Friday, 16 February 2018

US Regulation of Homeopathy #1 - Manufacture etc

US regulation of homeopathic medicines and the practice of homeopathy is complicated to say the least. Part of the reason is the nature of the US law system and issues of demarcation of jurisdiction of regulatory bodies. This is a very complicated subject and well beyond the scope of this blog!

Suffice to say, there is Federal law and State law. Regulation of some aspects of the manufacture of homeopathic medicines is at the Federal level but licensing of manufacturers and wholesalers is often at state level, regulation of marketing claims for homeopathic medicines is at both the Federal and State level and the regulation of the practice of homeopathy is at State level. The latter is complicated by the fact that "homeopathy" as a practice is comparatively rare. It is more commonly encountered as one of types of treatment employed in naturopathy. The regulatory status of naturopathy varies considerably from state to state. The number of states makes this a huge exercise.

At the Federal level, in general the Food and Drug Administration (FDA)  is responsible for regulation of the manufacturing side of homeopathic drugs. It also deals with the placing on the market of those homeopathic drugs that are prescription only (see below). The Federal Trade Commission (FTC) deals with the marketing of over the counter products. It is not intended to go into detail explaining their function or powers.

Over the past year or so, there have been a number events, mostly at the Federal level, that could have big impacts on the market for homeopathic medicines.

How many posts it will take to cover the whole subject is unknown but it will likely be more than three and they will not be short. Nor will they be an easy read. No apologies are made for this.

The Federal Food Drug and Cosmetic Act
The FDCA is a complex piece of legislation. It has a long history and has been subject to many amendments over the years. It is necessarily large as it attempts to do in one Act what other jurisdictions tend to split across multiple pieces of legislation. It is also not structured in a particularly structured fashion.

It is worth pointing out that the status of homeopathic drugs has never been particularly clear. This excellent article written by the FDA's official historian clearly demonstrates this. 

Definition
It provides a definition of a "drug" in Section 321
(g)(1) The term "drug" means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in accordance with the requirements of section 343(r) of this title is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 343(r)(6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a statement.
So, a "drug" is essentially a drug because it appears in a list of drugs OR if not, 
  • it is intended for use of diagnois, cure, mitigation, treatment or prevention of disesase in man or animals OR
  • it is intended to affect the structure or function of the body
Or is an ingredient of any of the above. Food items are not drugs. Nor are "dietary supplements". Dietary supplements will be dealt with later.
(j) The term "official compendium" means the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, official National Formulary, or any supplement to any of them.
Does not add anything. 

The FDCA does not provide an explicit definition of "homeopathic". The implication is that if a monograph of a substance appears in the Homoeopathic Pharmacopoeia of the United States (HPUS), it is considered homepathic. HPUS will be discussed in great depth later but this is very different from, say, the EU definition of a "homeopathic medicine". EU regulations are methods based for one thing. It is partly the process by which a product is prepared that determines whether it homeopathic. Another part of EU regulations is the degree of dilution - which simply does not exist in the FDCA.

The FDA have produced consumer guidance on homeopathic drugs. It gives a brief and very partial explanation of what homeopathy is but in the section "What are homeopathic products and how can you tell you are taking one?" it states -
There are no FDA-approved products labeled as homeopathic; this means that any product labeled as homeopathic is being marketed in the U.S. without FDA evaluation for safety or effectiveness. These products are often marketed as natural, safe and effective alternatives to approved prescription and nonprescription products, and are sold online and in major retail stores. 
Products labeled as homeopathic can contain a wide range of substances, including ingredients derived from plants, healthy or diseased animal or human sources, minerals, and chemicals. 
Products labeled as homeopathic generally include:
  • The word “Homeopathic”
  • The ingredients listed in terms of dilution, e.g. 1X, 6X, 2C
Which is not very helpful.

The FDA's current Compliance Guidelines - CPG Sec. 400.400 Conditions Under Which Homeopathic Drugs May be Marketed - can be found here. Note that compliance guidelines in themselves do not represent the law itself but rather what the FDA thinks is necessary to comply with law. Enforcement guidelines are something different - they represent FDA enforcement priorities. The FDCA does not de facto treat homeopathic drugs any differently from other drugs - the FDA chooses not to enforce the letter of the law in some cases.

Although CPG Sec. 400.400 does not have force of law it states -
Homeopathic Drug: Any drug labeled as being homeopathic which is listed in the Homeopathic Pharmacopeia of the United States (HPUS), an addendum to it, or its supplements. The potencies of homeopathic drugs are specified in terms of dilution, i.e., 1x (1/10 dilution), 2x (1/100 dilution), etc. Homeopathic drug products must contain diluents commonly used in homeopathic pharmaceutics. Drug products containing homeopathic ingredients in combination with non-homeopathic active ingredients are not homeopathic drug products.
Again, the reliance on HPUS. If a homeopathic drug contains any ingredients that are not in HPUS, at the moment the FDA would not regard them as homeopathic. This is true even when ingredients are listed as "inactive". 

Homoeopathic Pharmacopoeia of the United States
The HPUS website is here. It is a very strange thing to say the least. That what is essentially a reference work that defines a group of drugs under Federal law is under the control of a non-statutory body is odd.
The Homœopathic Pharmacopœia Convention of the United States is an all-volunteer organization that is funded through member dues, subscriptions and charitable giving. HPCUS is a 501(c)3 corporation, and as such all donations are deductible for tax purposes. Thank you for your support of the HPCUS!
Access to what is contained in HPUS costs money. This makes it impossible for consumers to determine whether homeopathic drugs are "homeopathic" or not. Criteria for inclusion in HPUS can be found here. The criteria mention efficacy - but obviously this has a different meaning than the dictionary definition. They also mention safety.

One of the strange aspects of the HPUS is that classifies some products as prescription only when the FDCA does not recognise any distinction between homeopathic drugs as long as they are in HPUS.

Manufacturing - Registration of producers and inspection
The FDCA starts to become confusing at this point. It certainly doesn't flow - as will be seen from the out of order numbered sections.

Section 360 - Registration of producers of drugs or devices is very clear.

(a) Definitions
As used in this section-
(1) the term "manufacture, preparation, propagation, compounding, or processing" shall include repackaging or otherwise changing the container, wrapper, or labeling of any drug package or device package in furtherance of the distribution of the drug or device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer or user; and
(2) the term "name" shall include in the case of a partnership the name of each partner and, in the case of a corporation, the name of each corporate officer and director, and the State of incorporation.

The section then goes on to describe in detail - 
  • For already registered producers, the need renew their registration on an annual basis.
  • The need for new producers to register.
  • The need for additional premises to be registered
  • The issue of unique ID numbers
  • Registration details are available to any one.
It then talks about exclusions from registration -

(g) Exclusions from application of sectionThe foregoing subsections of this section shall not apply to-(1) pharmacies which maintain establishments in conformance with any applicable local laws regulating the practice of pharmacy and medicine and which are regularly engaged in dispensing prescription drugs or devices, upon prescriptions of practitioners licensed to administer such drugs or devices to patients under the care of such practitioners in the course of their professional practice, and which do not manufacture, prepare, propagate, compound, or process drugs or devices for sale other than in the regular course of their business of dispensing or selling drugs or devices at retail;(2) practitioners licensed by law to prescribe or administer drugs or devices and who manufacture, prepare, propagate, compound, or process drugs or devices solely for use in the course of their professional practice;(3) persons who manufacture, prepare, propagate, compound, or process drugs or devices solely for use in research, teaching, or chemical analysis and not for sale;(4) any distributor who acts as a wholesale distributor of devices, and who does not manufacture, repackage, process, or relabel a device; or(5) such other classes of persons as the Secretary may by regulation exempt from the application of this section upon a finding that registration by such classes of persons in accordance with this section is not necessary for the protection of the public health.

Compounding pharmacies were mentioned in a previous post and that post linked to this article. In essence, compounding pharmacies are permitted to formulate medicines in response to a prescription from a licensed medical practitioner. Placing drugs on the open market is not permitted. Compounding pharmacies are subject to State regulation. (2) and (3) also forbid the placing on the market. The degree of abuse of exemptions is unknown but sufficient that FDA that felt it had to act.

It then goes onto discuss inspections. It sets out a risk-based approach to the frequency and scheduling of inspections. Section 374 - Inspection discusses the nature of these inspections, the powers of inspecting agents, the potential outcomes of such inspections (eg improvement notices) and various exemptions. Inspections are carried out on the basis of compliance with current Good Manufacturing Practice (cGMP).


(i) Registration of foreign establishments
(1) Every person who owns or operates any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device that is imported or offered for import into the United States shall, through electronic means in accordance with the criteria of the Secretary-(A) upon first engaging in any such activity, immediately submit a registration to the Secretary that includes-(i) with respect to drugs, the name and place of business of such person, all such establishments, the unique facility identifier of each such establishment, a point of contact e-mail address, the name of the United States agent of each such establishment, the name of each importer of such drug in the United States that is known to the establishment, and the name of each person who imports or offers for import such drug to the United States for purposes of importation; and(ii) with respect to devices, the name and place of business of the establishment, the name of the United States agent for the establishment, the name of each importer of such device in the United States that is known to the establishment, and the name of each person who imports or offers for import such device to the United States for purposes of importation; and(B) each establishment subject to the requirements of subparagraph (A) shall thereafter register with the Secretary during the period beginning on October 1 and ending on December 31 of each year.(2) The establishment shall also provide the information required by subsection (j).(3) The Secretary is authorized to enter into cooperative arrangements with officials of foreign countries to ensure that adequate and effective means are available for purposes of determining, from time to time, whether drugs or devices manufactured, prepared, propagated, compounded, or processed by an establishment described in paragraph (1), if imported or offered for import into the United States, shall be refused admission on any of the grounds set forth in section 381(a) of this title.(4) The Secretary shall specify the unique facility identifier system that shall be used by registrants under paragraph (1) with respect to drugs. The requirement to include a unique facility identifier in a registration under paragraph (1) with respect to drugs shall not apply until the date that the identifier system is specified by the Secretary under the preceding sentence.
This requires foreign producers to register and also makes them subject to inspection.
(j) Filing of lists of drugs and devices manufactured, prepared, propagated and compounded by registrants; statements; accompanying disclosures
(1) Every person who registers with the Secretary under subsection (b), (c), (d), or (i) shall, at the time of registration under any such subsection, file with the Secretary a list of all drugs and a list of all devices and a brief statement of the basis for believing that each device included in the list is a device rather than a drug (with each drug and device in each list listed by its established name (as defined in section 352(e) of this title) and by any proprietary name) which are being manufactured, prepared, propagated, compounded, or processed by him for commercial distribution and which he has not included in any list of drugs or devices filed by him with the Secretary under this paragraph or paragraph (2) before such time of registration. Such list shall be prepared in such form and manner as the Secretary may prescribe and shall be accompanied by-(A) in the case of a drug contained in the applicable list and subject to section 355 or 360b of this title, or a device intended for human use contained in the applicable list with respect to which a performance standard has been established under section 360d of this title or which is subject to section 360e of this title, a reference to the authority for the marketing of such drug or device and a copy of all labeling for such drug or device;(B) in the case of any other drug or device contained in an applicable list-(i) which drug is subject to section 353(b)(1) of this title, or which device is a restricted device, a copy of all labeling for such drug or device, a representative sampling of advertisements for such drug or device, and, upon request made by the Secretary for good cause, a copy of all advertisements for a particular drug product or device, or(ii) which drug is not subject to section 353(b)(1) of this title or which device is not a restricted device, the label and package insert for such drug or device and a representative sampling of any other labeling for such drug or device;(C) in the case of any drug contained in an applicable list which is described in subparagraph (B), a quantitative listing of its active ingredient or ingredients, except that with respect to a particular drug product the Secretary may require the submission of a quantitative listing of all ingredients if he finds that such submission is necessary to carry out the purposes of this chapter;(D) if the registrant filing a list has determined that a particular drug product or device contained in such list is not subject to section 355 or 360b of this title, or the particular device contained in such list is not subject to a performance standard established under section 360d of this title or to section 360e of this title or is not a restricted device a brief statement of the basis upon which the registrant made such determination if the Secretary requests such a statement with respect to that particular drug product or device; and(E) in the case of a drug contained in the applicable list, the name and place of business of each manufacturer of an excipient of the listed drug with which the person listing the drug conducts business, including all establishments used in the production of such excipient, the unique facility identifier of each such establishment, and a point of contact e-mail address for each such excipient manufacturer.(2) Each person who registers with the Secretary under this section shall report to the Secretary, with regard to drugs once during the month of June of each year and once during the month of December of each year, and with regard to devices once each year during the period beginning on October 1 and ending on December 31, the following information:(A) A list of each drug or device introduced by the registrant for commercial distribution which has not been included in any list previously filed by him with the Secretary under this subparagraph or paragraph (1) of this subsection. A list under this subparagraph shall list a drug or device by its established name (as defined in section 352(e) of this title), and by any proprietary name it may have and shall be accompanied by the other information required by paragraph (1).(B) If since the date the registrant last made a report under this paragraph (or if he has not made a report under this paragraph, since February 1, 1973) he has discontinued the manufacture, preparation, propagation, compounding, or processing for commercial distribution of a drug or device included in a list filed by him under subparagraph (A) or paragraph (1); notice of such discontinuance, the date of such discontinuance, and the identity (by established name (as defined in section 352(e) of this title) and by any proprietary name) of such drug or device.(C) If since the date the registrant reported pursuant to subparagraph (B) a notice of discontinuance he has resumed the manufacture, preparation, propagation, compounding, or processing for commercial distribution of the drug or device with respect to which such notice of discontinuance was reported; notice of such resumption, the date of such resumption, the identity of such drug or device (each by established name (as defined in section 352(e) of this title) and by any proprietary name), and the other information required by paragraph (1), unless the registrant has previously reported such resumption to the Secretary pursuant to this subparagraph.(D) Any material change in any information previously submitted pursuant to this paragraph or paragraph (1).(3) The Secretary may also require each registrant under this section to submit a list of each drug product which (A) the registrant is manufacturing, preparing, propagating, compounding, or processing for commercial distribution, and (B) contains a particular ingredient. The Secretary may not require the submission of such a list unless he has made a finding that the submission of such a list is necessary to carry out the purposes of this chapter.(4) The Secretary shall require persons subject to this subsection to use, for purposes of this subsection, the unique facility identifier systems specified under subsections (b)(3) and (i)(4) with respect to drugs. Such requirement shall not apply until the date that the identifier system under subsection (b)(3) or (i)(4), as applicable, is specified by the Secretary.
A lot of words to state that registered producers must provide a list of drugs/devices and supporting documentation.

Towards the end of the section are a number of declarations that cite interstate commerce. This is an odd concept to those who do not live in US or other countries with a Federal system of goverment. To a degree, it sets limits on Federal jurisdiction - if acts occur purely within a State, they fall under its jurisdiction. If products and services cross State borders, they fall under Federal jurisdiction. This is gross over-simplification. It is also the case that in these days of effective distribution networks and mail order purchase via the internet that any infractions will fall under Federal jurisdiction.

The situation is complicated slightly by the fact that some States do implement the FDCA in their own legislation. Other states have similar legislation that covers much of what the FDCA does but differently worded, partial or with a particular emphasis. For example, the focus may on food. Again, an over-simplification.

New Drug
The FDA do not require homeopathic drugs to go through the New Drug Application (NDA) process. This can be subject to abuse. The legal requirements are long and complex and can be found in Section 355 - New drugs and the following sub-sections. There is also copious guidance.

No homeopathic drug of sufficient dilution would make it through the NDA process. If a product could make it through the process then it would not be regarded as homeopathic. 


Over the counter and Prescription drugs
Unlike some other countries, the US only has two categories of drugs. It does not have the equivalent of the UK Phamacy Only Medicine (POM) - which do not require a prescription but can only be purchased from a pharmacy. Over the counter (OTC) drugs - which corresponds to the UK General Sales List (GSL - although OTC is often used in UK) and can be sold anywhere and Prescription only (Rx) which can only be obtained from a pharmacy in conjunction with a prescription from a licensed medical professional with the appropriate prescribing rights. However, some States have laws that effectively render some OTC the equivalent of the UK POM. Also, although there is no legal requirement, some pharmacies de facto treat some OTC drugs in this way. 

The criteria for determing whether a drug is OTC or Rx are not set in stone. When an NDA (or an application for a change in status from Rx to OTC) for an OTC drug is made it is evaluated by FDA. The ultimate decision on OTC status is made by the Office of Nonprescription Drug Products.
OTC drugs generally have these characteristics:
  • their benefits outweigh their risks
  • the potential for misuse and abuse is low
  • consumer can use them for self-diagnosed conditions
  • they can be adequately labeled
  • health practitioners are not needed for the safe and effective use of the product
Homeopathic drugs would appear to fail to meet several criteria - they have no benefits and effective use is not possible yet they are treated as OTC. They are not evaluated by the Office of Nonprescription Drug Products.

In some jurisdictions, method of delivery affects OTC/Rx status - eg drugs for delivery by injection are considered Rx. Homeopathic drugs typically come in the form of lactose pillules although some for topical use come in the form of creams or gels (which may have a soothing effect for some conditions). Ear and eye drops do exist. As do transdermal patches and even inhalers of a kind. Suppositories too.

As mentioned above HPUS does make a distinction between OTC and Rx but this is not reflected in the FDCA. It is unknown whether HPUS recognises novel routes of delivery.

Restricted Ingredients
Although there are no specific prohibitions on what ingredients homeopathic can contain in FDCA per se, the Controlled Substances Act, for example, would make it legally difficult for manufacturers to obtain certain ingredients. Many controlled substances are relatively new so they will not appear in HPUS but older products such as Opium and some other opiates do.

Because of the lack of restrictions on dilution, products such as Opium 1x are in theory possible but would be subject to the CSA. 

Adulterated and Misbranded Drugs
These terms are not used in the same way as the dictionary definitions. They have broader and yet specific meanings.

Section 351 - Adultered drugs and devices states -
A drug or device shall be deemed to be adulterated— 
(a) Poisonous, insanitary, etc., ingredients; adequate controls in manufacture(1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (2)(A) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or (B) if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess; or (C) if it is a compounded positron emission tomography drug and the methods used in, or the facilities and controls used for, its compounding, processing, packing, or holding do not conform to or are not operated or administered in conformity with the positron emission tomography compounding standards and the official monographs of the United States Pharmacopoeia to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, that it purports or is represented to possess; or (3) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (4) if (A) it bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of section 379e(a) of this title, or (B) it is a color additive the intended use of which in or on drugs or devices is for purposes of coloring only and is unsafe within the meaning of section 379e(a) of this title; or (5) if it is a new animal drug which is unsafe within the meaning of section 360b of this title; or (6) if it is an animal feed bearing or containing a new animal drug, and such animal feed is unsafe within the meaning of section 360b of this title.
This would seem to indicate that nosodes and sarcodes would be considered "adultered drugs" as they are made from all sorts of unpleasant things. Excrement, pus and diseased tissue to name a few. More importantly, products are considered adultered if not manufactured to current Good Manufacturing Practice (cGMP) standards.
(b) Strength, quality, or purity differing from official compendium
If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium. Such determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in such compendium, except that whenever tests or methods of assay have not been prescribed in such compendium, or such tests or methods of assay as are prescribed are, in the judgment of the Secretary, insufficient for the making of such determination, the Secretary shall bring such fact to the attention of the appropriate body charged with the revision of such compendium, and if such body fails within a reasonable time to prescribe tests or methods of assay which, in the judgment of the Secretary, are sufficient for purposes of this paragraph, then the Secretary shall promulgate regulations prescribing appropriate tests or methods of assay in accordance with which such determination as to strength, quality, or purity shall be made. No drug defined in an official compendium shall be deemed to be adulterated under this paragraph because it differs from the standard of strength, quality, or purity therefor set forth in such compendium, if its difference in strength, quality, or purity from such standard is plainly stated on its label. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homoeopathic Pharmacopoeia of the United States it shall be subject to the requirements of the United States Pharmacopoeia unless it is labeled and offered for sale as a homoeopathic drug, in which case it shall be subject to the provisions of the Homoeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia.
This has implications for "homeopathic" drugs of low dilution that would be treated differently other jurisdictions.
(j) Delayed, denied, or limited inspection; refusal to permit entry or inspection
If it is a drug or device and it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.
In essence, if cGMP inspection is unable to be carried out, a drug can be declared "adultered".

Section 352 - Misbranded drugs and devices states -
A drug or device shall be deemed to be misbranded- 
(a) False or misleading label
(1) If its labeling is false or misleading in any particular. Health care economic information provided to a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis, carrying out its responsibilities for the selection of drugs for coverage or reimbursement, shall not be considered to be false or misleading under this paragraph if the health care economic information relates to an indication approved under section 355 of this title or under section 262(a) of title 42 for such drug, is based on competent and reliable scientific evidence, and includes, where applicable, a conspicuous and prominent statement describing any material differences between the health care economic information and the labeling approved for the drug under section 355 of this title or under section 262 of title 42. The requirements set forth in section 355(a) of this title or in subsections (a) and (k) of section 262 of title 42 shall not apply to health care economic information provided to such a payor, committee, or entity in accordance with this paragraph. Information that is relevant to the substantiation of the health care economic information presented pursuant to this paragraph shall be made available to the Secretary upon request.
Only the first sentence of (a) is of potential relevance.
(b) Package form; contents of label 
If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count: Provided, That under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary. 

(c) Prominence of information on label  
If any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Although general provisions, they equally apply to homeopathic drugs.
(f) Directions for use and warnings on label
Unless its labeling bears (1) adequate directions for use; and (2) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users, except that where any requirement of clause (1) of this paragraph, as applied to any drug or device, is not necessary for the protection of the public health, the Secretary shall promulgate regulations exempting such drug or device from such requirement. Required labeling for prescription devices intended for use in health care facilities or by a health care professional and required labeling for in vitro diagnostic devices intended for use by health care professionals or in blood establishments may be made available solely by electronic means, provided that the labeling complies with all applicable requirements of law, and that the manufacturer affords such users the opportunity to request the labeling in paper form, and after such request, promptly provides the requested information without additional cost. 
A drug is misbranded if it does not carry direction for use or adequate warnings. 
(g) Representations as recognized drug; packing and labeling; inconsistent requirements for designation of drug
If it purports to be a drug the name of which is recognized in an official compendium, unless it is packaged and labeled as prescribed therein. The method of packing may be modified with the consent of the Secretary. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homoeopathic Pharmacopoeia of the United States, it shall be subject to the requirements of the United States Pharmacopoeia with respect to packaging and labeling unless it is labeled and offered for sale as a homoeopathic drug, in which case it shall be subject to the provisions of the Homoeopathic Pharmacopoeia of the United States, and not those of the United States Pharmacopoeia, except that in the event of inconsistency between the requirements of this paragraph and those of paragraph (e) as to the name by which the drug or its ingredients shall be designated, the requirements of paragraph (e) shall prevail.
Not particularly interesting.
(i) Drug; misleading container; imitation; offer for sale under another name
(1) If it is a drug and its container is so made, formed, or filled as to be misleading; or (2) if it is an imitation of another drug; or (3) if it is offered for sale under the name of another drug.
This has particular implications for homeopathic drugs that purport to be equivalent in action to actual drugs - the most infamous example being "HCG Drops". These will be discussed in greater depth later.
(o) Drugs or devices from nonregistered establishments 
If it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 360 of this title, if it is a drug and was imported or offered for import by a commercial importer of drugs not duly registered under section 381(s) of this title, if it was not included in a list required by section 360(j) of this title, if a notice or other information respecting it was not provided as required by such section or section 360(k) of this title, or if it does not bear such symbols from the uniform system for identification of devices prescribed under section 360(e) of this title as the Secretary by regulation requires.
This seems a very indirect way to make the sale of homeopathic drugs manufactured in nonregistered facilities illegal.

Pharmacovigilence
Adverse drug reactions (ADRs) do happen. Most countries do have systems for the reporting of ADRs. Consumers may not be aware that regulatory bodies have schemes in place and sometimes will report ADRs to the manufacturer. The FDCA places a legal duty on manufacturers to pass ADRs on to the FDA.

There are problems with ADRs in that, generally, causation of an individual reaction are not known. Regulatory bodies therefore tend to look for patterns in ADRs for individual products. Frequency and/or severity of ADRs are what prompt regulators to carry out investigatory actions. If a drug is not commonly used and/or ADRs are rare (but severe) it can take time for sufficient data to accumulate.

The idea that homeopathic drugs do not have side effects may be a barrier to consumer reporting of ADRs. Of course, products of sufficient dilution correctly manufactured, are extremely unlike to cause ADRs but as discussed, some products are of low dilution. There is also the problem of contamination. The FDCA treat this as "adulteration".


Offenses and Penalties
The FDCA provides for a number of civil and criminal offences and sanctions against adultered drugs. Something that needs to be understood is that FDCA works on the principle of strict liability - ignorance of the law is no defence. 

Section 331 - Prohibited Acts states -


The following acts and the causing thereof are prohibited:
(a) The introduction or delivery for introduction into interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.(b) The adulteration or misbranding of any food, drug, device, tobacco product, or cosmetic in interstate commerce.(c) The receipt in interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.(d) The introduction or delivery for introduction into interstate commerce of any article in violation of section 344, 350d, 355, or 360bbb–3 of this title.(e) The refusal to permit access to or copying of any record as required by section 350a, 350c, 350f(j), 350e, 354, 360bbb–3, 373, 374(a), 379aa, or 379aa–1 of this title; or the failure to establish or maintain any record, or make any report, required under section 350a, 350c(b), 350f, 350e, 354, 355(i) or (k), 360b(a)(4)(C), 360b(j), (l) or (m), 360ccc–1(i), 360e(f), 360i, 360bbb–3, 379aa, 379aa–1, 387i, or 387t of this title or the refusal to permit access to or verification or copying of any such required record; or the violation of any recordkeeping requirement under section 2223 1 of this title (except when such violation is committed by a farm).(f) The refusal to permit entry or inspection as authorized by section 374 of this title.(g) The manufacture within any Territory of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.(h) The giving of a guaranty or undertaking referred to in section 333(c)(2) of this title, which guaranty or undertaking is false, except by a person who relied upon a guaranty or undertaking to the same effect signed by, and containing the name and address of, the person residing in the United States from whom he received in good faith the food, drug, device, tobacco product, or cosmetic; or the giving of a guaranty or undertaking referred to in section 333(c)(3) of this title, which guaranty or undertaking is false.
This clearly prohibits activities associated with manufacture, distribution and sale of adultered or misbranding drugs. It also prohibits refusal to allow inspection. It then goes on to talk about counterfiet drugs, various acts associated with margerine and tobacco. "Causing" in the context of this section has the meaning of instructing others to perform such acts.

Whilst the following Sections 332 - Injunctions and 333 - Penalties are important, they omit other sanctions open to the FDA. This, although it comes from part of the FDA website dealing with veterinary products, is very clear. The options opened to the FDA are -
Warning Letters - are sent to the individuals or firms, advising them of specific noted violations.; These letters request a written response as to the steps which will be taken to correct the violation. These letters constitute one form of warning that can be issued under current Agency policy. 
Seizure - An action brought against an FDA-regulated product because it is adulterated and/or misbranded within the meaning of the Act. The purpose of such an action is to remove specific violative goods from commerce. 
Injunction - An order by a court that requires an individual or corporation to do or refrain from doing a specific act. FDA may seek injunctions against individuals and/or corporations to prevent them from violating or causing violations of the Act. 
Criminal prosecution - may be recommended in appropriate cases for violation of Section 301 of the Act.; Misdemeanor convictions, which do not require proof of intent to violate the Act, can result in fines and/or imprisonment up to one year. Felony convictions, which apply in the case of a second violation or intent to defraud or mislead, can result in fines and/or imprisonment up to three years.
In the case of criminal prosecution, fines can be levied -
  • Up to $100,000 for a misdemeanor by an individual that does not result in death.
  • Up to $200,000 for a misdemeanor by a corporation that does not result in death.
  • Up to $250,000 for a misdemeanor by an individual that results in death, or a felony.
  • Up to $500,000 for a misdemeanor by a corporation that results in death, or a felony.
In all cases, a maximum of one year imprisonment is also possible.

Supplements
Homeopathic drugs are not supplements. Supplements are regulated as food to a large degree. To say the status of supplements is controversial is an understatement. The Dietary Supplement Health and Education Act of 1994 (DSHEA) defines supplements -

The term 'dietary supplement'— "(1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:(A) a vitamin; (B) a mineral; (C) an herb or other botanical; (D) an amino acid; (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C),(D),or(E);  

It then goes on to state that supplements can not contain certain substances (drugs etc), that they are not intended as food. The FDA regulate supplements with regards to cGMP compliance and adulteration and misbranding. This is too complex a subject to be discussed here.

What matters the most is terms of what claims are permitted for such products, the bar is set very low in terms of substantiation. Some products make claims that would be consistent with the FDCA definition of a drug but this is very grey area. 
Some homeopathic drugs are labelled as "homeopathic supplements". This is essentially meaningless and somewhat bogus. It may be done out of ignorance or it may be an attempt to avoid regulations (in particular the restriction to ingredients found in HPUS). Use of the term "homeopathic", use of dilution indicators etc, render a product a homeopathic drug. This is true for products described as dietary supplements or variations thereof.


Enforcement Actions
One way to determine what the FDA's approach to enforcement is by examining what enforcement actions have been taken and the which sections of the FDCA are cited. Typically, the FDA deals with infractions of the FDCA by warning letters and do not need to resort to prosecution. It is important to note that warning letters do not always contain an exhaustive list of infractions - the emphasis is on ensuring manufacturer/vendor compliance.

The most notorious example of problems with a "homeopathic" drug was the Zicam case although in other jurisdictions, Zicam would not be classified as such. The dilution levels are low and the product does contain significant levels of active ingredients - zinc acetate and zinc gluconate. Zicam caused anosmia - loss of sense of smell - in some consumers. the manufacturer Matrixx Initiatives was subject to a number of legal actions - some of which are still ongoing. In 2006, they settled with 340 customers for $12 million.

Cases of anosmia related to Zicam had been reported to the FDA from 1999 yet they only sent a warning letter to Matrixx Initiatives in 2009. The letter is no longer on the FDA website but it can be found here. The letter cites regulations relating new drugs and misbranding but also safety - the FDA state quite clearly that the product required approval that it did not have. Matrixx Initiatives were put under a great deal of pressure to recall the product. It was only in 2013 that the FDA closed out the case.

It is also the case that Matrixx Initiatives had received ADRs but did not pass them onto the FDA.

Less well known is the business of homeopathic hCG. This is a long story not all of which is in the public domain. Essentially there is a Very Low Calorie Diet (VLCD) that also involves the use of injections of human Chorionic Gonadotropin (hCG). It has been around since the 1950s. VLCDs are potentially dangerous and should only be conducted under medical supervision. hCG is Rx and licensed for treatment of female infertility. Any weight loss is due to the VLCD, not the hCG. Historically, the FDA have acted against those offering hCG for weight loss.

It is not clear who dreamed up the idea of homeopathic hCG. The idea that a dilution of hCG would have the same purported effect as hCG is nonsensical and violates the tenets of homeopathy. The marketing of these products represents a double lie. As hCG is not in HPUS, these products are not homeopathic drugs. The marketing of these products encouraged potentially dangerous behaviour - often not even mentioning the need for medical supervision. The products were sold by multiple internet vendors under various brands, even using Amazon and eBay. It is known that multiple complaints were made to the FDA. The FDA and FTC cooperated in enforcement actions. Warning letters were send to a number of vendors/manufacturers -
There were several other letters as well but they have proved difficult to track down but these letters provide more than enough information. Ignoring the FTC aspects of the letters (which will be discussed in a future post), the FDA stated that they considered the products new drugs. The FDA stated that disclaimers were meaningless and the marketing claims made meant that the products were drugs and Rx.

The FDA and FTC explicitly stating that homeopathic hCG products were illegal had a dramatic effect beyond these letters. Amazon and eBay would pull the products as soon as they were aware of them. If vendors used PayPal, they would suspend their accounts.

Some vendors changed the formulation of the products and the names changed but products still turn up from time to time. Nutri-Dyn Midwest, Inc had a warning letter in 2017. There are products still on the market and that website has this extraordinary page that brazenly violates both the FDCA and the FTC Act.

Another high profile case involves Hylands etc teething products. This was widely reported. These products contained belladonna, better known as deadly nightshade, which is a member of potato/tomato family. The plant is extremely toxic due to alkaloids such as atropine and hyoscine. The FDA has over the years recieved a number of ADRs related to the products  - including seizures.

The FDA carried out an inspection of Standard Homeopathic Products (parent company of the Hylands brand) in 2010. This inspection raised a number of issues. The FDA were concerned enough to issue a safety alert about teething products and advised consumers to dispose of them.

The FDA felt that Standard had not responded to the issues raised by the inspection and issued a warning letter in 2011. The letter cites numerous examples of cGMP non-compliance. The importance of cGMP compliance can not be overstated. The issue is not whether the products manufactured were safe or not but that there were inadequate controls to ensure safety. Put another way, safety became a matter of luck not judgement. Whilst the requirements of cGMP compliance are onerous, they are not impossible to acheive.

Then in 2013, the FDA looked at the Hylands website and found it contained a number of misbranded products. It issued a warning letter making it very clear that the marketing claims and indications for certain products were not permissable. This suggests that the FDA were keeping an eye on Standard.

In September 2016, the FDA inspected Standard and again found problems with belladonna products. Shortly afterwards, they issued a press release regarding belladonna teething products. The FDA also stated that there were analysing ADRs.

At roughly the same time, the FDA inspected Raritan and found problems with a similar product. Raritan launched a voluntary recall of the product in November 2016.

In January 2017 the FDA issued a laboratory report on belladona teething products marketed as Hylands and also CVS (manufacturered by Raritan). As the report makes clear, given the dilutions involved, these products should not have contained detectable levels of belladonna but they did. As a letter to Standard makes clear, Standard made no immediate attempt to recall the products. The letter is a formal request for Standard to issue a recall, which it finally did in April 2017.

The media became interested in the story at some point. Stories appeared even in the mainstream press - often couched in terms of as many as ten children having died as a result of being given these products. As mentioned earlier, ADRs do not always reveal causation.

The reactions of supporters of homeopathy varied. As might be expected, some painted the FDA actions as part of a conspiracy. Others stated that not all samples contained belladonna and those that did contained very little. Bizarre justifications were also made although the lines of those critical of homeopathy could not state that homeopathy is ineffective and that these products were potentially dangerous. Supporters seemed to fail to grasp that the issue was failure of process controls. Anyone familiar with statistical process control would tell you that.

GUNA, Inc and King Bio Inc have both been sent waring letters jointly issued by the FDA and the FTC as part of a clampdown on vendors offering products for the treatment of opioid addiction. Offering useless products in the climate of increasing problems with opioid addiction in the US can only be regarded as incredibly cynical. As above, the FTC element will be discussed in the next post. The Guna product would not be considered homeopathic in other jurisdictions as it is a combination product that contains several very low dilutions - but they are in HPUS. The FDA state that neither of these products are permitted on the basis that narcotic addiction is not amenable to self-treatment. The products would be considered Rx.

  


Wednesday, 14 February 2018

The true nature of CEASE Therapy

Normally I don't use the "I" pronoun. But during research into CEASE therapy, I came across something very disturbing. Below is a verbatim extract from the CEASE therapy book.
... All kinds of detoxification reactions may occur. The most common are eliminative reactions with an increase of reactivity (fever). Fever should not be treated with medication, as it is a healthy reaction of the organism and not a disease! It helps greatly to overcome an acute disturbance, shortens the healing process, stimulates reactivity and avoids complications. Eliminations like diarrhea, flu, expectoration, and bad-smelling and cloudy urine should also be left alone, because they are a part of the healing process.
A case of diarrhea as a cleansing reaction
I remember an autistic child who got diarrhea during the detoxification of his vaccines. The diarrhea relieved his system so much, that his autism almost disappeared instantly. After ten days the mother started to worry and went to the family doctor because I was absent at that moment. He prescribed Immodium (Loperamide) to stop the diarrhea by paralyzing the peristaltic motions of the bowels. Almost immediately the child had a setback and became autistic as before. The diarrhea was a perfect detoxification for his bowels and brain. Neither the doctor not the mother understood this, and the medication interfered with the progress of the cure.
No comment is necessary. 
 
 
 

Tuesday, 30 January 2018

A Modest Proposal #1

This will be very short.

Something that became very clear from research into CEASE Therapy is that there are few legal restraints on homeopaths using it on autistic children. It has also become clear that none of the homeopathic trade associations want to do anything about members who use it.

The last post (which is a work in progress) is a translation of the Swedish Patient Safety Law (Law). It is suggested that some of the provisions should be incorporated into UK law.

Proposal - Restricting Treatment by Non-Medically Qualified
The Law restricts treatment of certain conditions such as cancer and certain groups of people to the medically qualified (and those people under their supervision - for example, what in the UK would be called healthcare assistants).

It would be perfectly possible to do the same in UK law. It may even be possible to "improve" on the law by, for example, creating a more extensive list of conditions that can not be treated. It would also be possible to extend the list of persons who can not be treated from children under 8 years old etc to include anyone who lacks the capacity to give consent.

It would be a criminal offence under UK law for the medically unqualified to treat listed conditions/groups of people.

Proposal - Defining Medically Qualified
The Law includes Chiropractors and Naprapaths. It would be unwise for UK legislation to treat them as medically qualified. Unfortunately, UK law doesn't treat psychotherapists as "qualifed". Many in the profession have called for statutory regulation and "psychotherapist" being a protected title.

If SR status for psychotherapists can not be acheived in the short term, transitional measures could be put into place.



Sunday, 28 January 2018

Patientsäkerhetslag (2010:659)

This is the Swedish Patient Safety Act 2010. It is an important piece of legislation in that it controls who can treat certain patients for certain conditions. It could be viewed as a model for legislation in other countries - although in most countries there is existing legislation that covers most of the provisions.

Google Translate does do a reasonable job of translation but not perfect. This is a work in progress - it is published before the translation is actually finished because there is an immediate need to share some of this. Help with improving translation would be much appreciated.

No analysis is made here although some explanatory notes are given. Some comparisons to UK legislation/regulation are made. Use of a serif font indicates content is not from the translation of the original document.

Chapter 5 is the most important.

Content:

  • Chapter 1 Preliminary provisions
  • Chapter 2 Registration of business etc.
  • Chapter 3 Caregiver's obligation to conduct systematic patient safety work
  • Chapter 4 Eligibility Questions
  • Chapter 5 Restrictions on the right of non-health professionals to take certain health care measures
  • Chapter 6 Obligations for healthcare professionals and others
  • Chapter 7 Health and Social Care Inspectorate
  • Chapter 8 Probation and revocation of registration, etc.
  • Chapter 9 Healthcare Responsibility Board
  • Chapter 10 Penalties and appeal, etc.
  • Transitional

Chapter 1 Preliminary provisions

The purpose and content of the law

Section 1 This Act aims to promote high standards ofpatient safety in health care and related activities. The Act contains provisions on
- notification of activities, etc. (Chapter 2),
- the duty of the healthcare provider to conduct a systematic patient safety work (Chapter 3),
- competence issues (Chapter 4),
- restrictions on the right of healthcare professionals to take some health care measures (Chapter 5),
- obligations for healthcare professionals, etc. (Chapter 6),
- Health and Social Care Inspectorate (Chapter 7),
- Probation and revocation of registration, etc. (Chapter 8),
- Healthcare Responsibility Board (Chapter 9), and
- penalties and appeal, etc. (Chapter 10)
General provisions on health and dental healthcare goals and requirements are contained in the Health Care Act (2017: 30), the Patient Act (2014: 821) and the Dentistry Act (1985: 125). Law (2017: 62) .

Definitions

Section 2 Healthcare refers to activities covered by the Health Care Act (2017: 30), the Dental Care Act (1985: 125), the Act (2001: 499) on the circumcision of boys and drug retailing activities under the Act (2009: 366) on trade in pharmaceuticals. Law (2017: 62) .
Section 3 The term "health care provider" in this Act means state authority, county council and municipality in respect of such healthcare as the authority, county council or municipality is responsible for, as well as any other legal person or individual healthcare practitioner.
The Swedish healthcare system is structured differently from the UK. For one thing, responsibility falls on the various tiers of national and local government rather than the health service existing outside of it.
Section 4 Healthcare professionals are referred to in this Act as
1. A person who has certification for a health care profession;
2. Employees working at hospitals and other healthcare institutions who participate in the healthcare of patients.
3. the person who, otherwise, in the healthcare of patients, supports a legitimate professional,
4. pharmacist who manufactures or expedites pharmaceuticals or provides advice and information;
5. staff at the Poison Information Center providing advice and information; and
6. staff at the emergency department and healthcare counseling which provides help or advice and information to the care-seeking.
For the purposes of the first subparagraph, paragraphs 1 and 3 shall be treated as legally qualified persons who, in accordance with specific regulations, have the corresponsing qualifications.
The Government may issue regulations requiring other groups of healthcare professionals to be covered by the Act. Law (2016: 150) .
Section 5 For the purposes of this Act, "bodily injury" means suffering, bodily or mental injury or illness, as well as deaths which could have been avoided if adequate measures had been taken in connection with the patient's contact with the health service.
Serious healthcare injury refers to a personal injury that 
1. is permanent and is not trivial, or 
2. has led to a significantly increased need for care or death of the patient.
Section 6 Patients' safety means protection against personal injury in this Act.

Chapter 2 Registration of business etc.

Notification of business

Section 1 The person who intends to carry out activities covered by the Health and Social Care Inspectorate in accordance with this Act shall report this to the inspection no later than one month before the activity commences. Law (2012: 957) .
Section 2 If the activity is changed or moved completely or substantially, this must be reported to the Health and Social Care Inspectorate within one month after the implementation. If the activity is closed, it must be reported to the Inspectorate as soon as possible. Law (2012: 957) .
Section 3 The government or government authority determined by the Government shall issue regulations regarding the fulfillment of the notification obligation under sections 1 and 2.
"Business" has a broader meaning here than purely commercial enterprise. The Health and Social Care Inspectorate is similar to the English Care Quality Commission.

Register

Section 4 The Health and Social Care Inspectorate shall maintain an automated register of activities reported under this chapter. The register may be used for supervision and research as well as for the production of statistics.
The Health and Social Care Inspectorate shall also maintain an automated register of healthcare facilities and entities referred to in Chapter 7. Section 7. The registry may be used for supervision, research, preparation of statistics and placement of patients.
The Health and Social Care Inspectorate is the person responsible for processing personal data in the registry.
The government announces regulations on which authorities may have direct access to the data in the Health and Social Care InspectorateLaw (2012: 957) .
Section 5 The Government shall issue regulations concerning the
first limitation of the information that the registers under section 4 may contain, and
2. the deletion of data in the registers pursuant to section 4.

Chapter 3 Care provider's obligation to conduct systematic patient safety work

General provisions

Section 1 The care provider shall plan, manage and control the activities in such a way as to maintain the requirement of good care in the health care act (2017: 30) and the dental care Act (1985: 125). Law (2017: 62) .
Section 2 The healthcare provider shall take the measures necessary to prevent patients from suffering healthcare injury. For actions that can not be taken immediately, a schedule must be established.
Section 3 The care provider shall investigate events in the business that have caused or could have caused a healthcare injury. The purpose of the investigation shall be to
1. as far as possible clarify the course of events and the factors that have influenced it, and
2. provide a basis for decisions on measures intended to prevent similar occurrences from occurring or to limit the effects of such events if they can not be completely prevented.
Corresponding investigative obligation has the activity of the person referred to in Chapter 7. Section 7 for events in the business that has caused or could have caused such serious damage as referred to in Section 6.
Section 4 The care provider shall provide the patients and their families with the opportunity to participate in patient safety work.

Notification to the Health and Social Care Inspectorate

Section 5 The care provider shall, unless otherwise specifically prescribed in accordance with the third paragraph, report to the Health and Social Care Inspectorate that events that have resulted or could have caused a serious healthcare injury. Corresponding notification obligation, the person who is engaged in activities referred to in Chapter 7, Section 2. The notification must be made as soon as the event has occurred.
The care providers shall, at the same time as the notification or immediately thereafter, submit to the Health and Social Care Inspectorate the investigation of the event as prescribed in section 3, first paragraph.
The Government or the authority determined by the Government may, pursuant to Chapter 8, Section 7 of the Government Form shall issue regulations on notifications from healthcare providers within the Armed Forces and the Defense Material Works. Law (2017: 786) .
Section 6 If any person has suffered or been exposed to the risk of suffering from a serious injury other than a healthcare injuries due to safety deficiencies in the activities of a healthcare institution or unit referred to in Chapter 7, Section 7, the healthcare provider or unit shall report this to the Health and Social Care Inspectorate as soon as the event has occurred.
The care provider or the unit shall, at the same time as the notification or immediately thereafter, submit to the Health and Social Care Inspectorate the investigation of the event as prescribed in Section 3, second paragraph. Law (2012: 957) .
Section 7 A healthcare provider shall notify the Health and Social Care Inspectorate without delay if there is reasonable reason to fear that a person who has a healthcare professional who is active or has been in charge of the healthcare provider may constitute a danger for patient safety. Law (2012: 957) .

Obligation to inform patients of the occurrence of healthcare injuries

Section 8 The care provider shall as soon as possible inform a patient who has suffered a healthcare injury if:
1. there has been an event that has caused a personal injury;
2. what measures the healthcare provider intends to take that a similar event should not occur again,
3. the healthcare provider's obligation to handle complaints and views;
4. the task of the patient committees pursuant to section 2, first paragraph, of the Act (2017: 372) on complaints against health care to assist the patient to raise complaints and to have their complaints answered by the healthcare provider;
5. the ability to report complaints to the Health and Social Care Inspectorate in accordance with Chapter 7. Section 10, and
6. The possibility of requesting compensation under the Patient Injury Act (1996: 799) or from the Medical Insurance.
The information should be provided to a patient, if the patient requests it or can not access the information.
Information about the information provided must be noted in the patient record. Law (2017: 378) .
8 a § The care provider shall receive complaints from and against their patients regarding their own activities. Law (2017: 378) .
8b §  The care provider must respond promptly to complaints from patients and their relatives. Complaints must be answered appropriately and with regard to the nature of the complaint and the individual's ability to access information.
The care provider shall provide the complainant with an explanation of what has occurred, and 
2. a description of the measures that the care provider intends to take to prevent a similar event from occurring. Law (2017: 378) .
8 c §  Information under 8 or 8b § may not be given to the patient or any related person in case of confidentiality or professional secrecy. Law (2017: 378) .
8th § The care provider is obliged to assist the Board to the extent necessary for the Board to fulfill its mission under Section 2, first paragraph, of the Act (2017: 372) on complaints against Healthcare. Law (2017: 378) .
8th § If it is clear that the complaint should be handled by another healthcare provider than the person who has received the complaint, the recipient may hand over the case to the other care provider for further processing. In such cases, the case shall be handed over promptly. Law (2017: 378) .

Documentation Requirement

Section 9 The care provider shall document how the organizational responsibility for patient safety work is distributed within the activities.
Section 10 The care provider shall draw up a patient safety report by 1 March each year, indicating
1. how patient safety work has been carried out during the previous calendar year,
2. what measures have been taken to increase patient safety, and
3. what results have been achieved.
The Patient Safety Report shall be kept available to anyone wishing to share it.

Authorization, etc.

Section 11 The government or government authority determined by the government may issue regulations on the elements to be included in the healthcare provider's systematic patient safety work.
Section 12 The government or government authority determined by the Government shall issue regulations on
1. Compliance with the obligation to notify in accordance with sections 5-7 and
2. What information should be included in a patient safety report under section 10.

Chapter 4 Eligibility Questions

Accreditation

Section 1 A person who, as stated in the table below, has completed a university degree or has completed a course of education and, as appropriate, practical experience shall, upon application, receive a certificate of professional accreditation.
Certificates may not be notified if the conditions are such that the credentials would have been revoked under the provisions of Chapter 8. if the applicant had been accredited.
An accredited psychotherapist must indicate his or her basic education in connection with his or her professional activity.
The government or government authority determined by the government may, in the cases specified in the table, provide regulations on the training and practical experience required for accreditation.

Title
Pharmacist
Occupational Therapist
Audiologist
Midwife
Biomedical Scientist
Dietitian
Physiotherapist
Chiropractor
Speech Therapist
Doctor
Naprapath
Optician
Orthotist
Psychologist
Psychotherapist
Dispenser
Radiographer
Medical Physicist
Nurse
Dental Hygienist
Dentist


The government may issue regulations requiring that other education programs other than those listed in the table be given the right to credentials. Law (2013: 1149) .

Section 2 Any person who, in any other way than through such education or practical experience as referred to in section 1, has acquired equivalent qualifications, may be credited to the profession upon application.
Section 3 The protected title may only be used by the person who has received accreditation under sections 1 or 2.

Regulated medical professions in Sweden are largely the same as in the UK and some other European countries. Naprapthy is almost unheard in the UK - it can be thought of as akin to both chiropractic and osteopathy but without some of the more vitalistic overtones. Dispenser (Receptarie) is a role only found in Sweden, Norway, Finland and Russia. Pharmacists have a Masters degree, a Dispenser has a Bachelors degree - so they are more qualified than a UK pharmacy technician.

Exclusive right to profession

Section 4 Ability to practice a profession as a pharmacist, midwife, doctor, dispenser and dentist is confined to those who have a license for the profession or who is specifically instructed to practice it.

Protected job title

Section 5 A professional title referred to in Section 1 may be used only by the person who has a certificate for the profession or undergoes the prescribed practical experience.
Section 6 In occupational activities in the field of healthcare, the person who, according to section 5, has no jurisdiction to use a protected professional title, may not use a title that may be confused with such a title.
Section 7 has been repealed by law (2012: 310) .

Specialist

Section 8 A certified medical practitioner or dentist who has undergone certain further training shall, upon application, receive accreditation of specialist competence.
Unless otherwise specifically stipulated, a physician or dentist may indicate that he or she has specialist qualifications in the specialty of his profession only if he or she has a certificate of specialist competence as referred to in the first paragraph. Law (2016: 150) .
Section 9 Unless otherwise specifically stipulated, a nurse may use a title equivalent to a specialist nurse's degree only if he or she has obtained such a degree. Law (2016: 150) .

Competent authority

Section 10 The National Board of Health and Welfare examines applications for accreditation, in particular the appointment of a profession and certificate of specialist competence. Law (2012: 310) .

Other authorizations

Section 11 The government or government authority determined by the Government may issue regulations on accreditation and other qualifications for healthcare professionals.
Section 12 The Government may issue regulations on fees for examining the application for accreditation and other qualifications.

Chapter 5 Restrictions on the right of non-health professionals to take certain health care measures

Section 1 Other than healthcare professionals no-one may professionally examine another's health condition or treat someone else for illness or equivalent condition by taking or prescribing any of the following measures for prevention, cure or mitigating purposes:
1. treat such infectious diseases as according to infectious diseases (2004: 168) are notifiable diseases,
2. treat cancer and other malignant tumors, diabetes, epilepsy or conditions in connection with pregnancy or childbirth;
3. examine or treat another person during general anesthesia or during local anesthesia by injection of anesthetics or under hypnosis,
4. treat someone else with radiological methods,
5. Without personal examination of the person seeking him or her, provide written advice or instructions for treatment; 
6. examine or treat children under eight years; or 
7. try out contact lenses.

Chapter 6 Obligations for healthcare professionals and others

General obligations

Section 1 Healthcare professionals shall perform their work in accordance with science and proven experience. A patient should be given expert and caring healthcare that meets these requirements. Care should be designed and implemented as far as possible in consultation with the patient. The patient should be shown care and respect.
Section 2 The healthcare personnel are responsible for the performance of their duties.
The first paragraph does not constitute a limitation on the healthcare provider's liability under this Act or other constitution.
Section 3 The healthcare staff may delegate a task to someone else only when it is in accordance with the requirement for good and safe care.
The person who delegates a task to someone else is responsible for the fact that he has the ability to fulfill the task.
Section 4 Healthcare professionals are required to contribute to maintaining high patient safety. To this end, the staff shall report to the healthcare provider risks for personal injury and events that have caused or could have caused a healthcare injury.
Healthcare professionals have the same reporting obligation, even in case of harm other than healthcare injuries resulting from safety deficiencies in the activities of such healthcare institution or unit referred to in Chapter 7. Section 7.
Section 5 Healthcare professionals shall, in matters relating to children who are ill or at risk, do not interact with social organizations, organizations and others concerned. Regarding disclosure of information, the restrictions contained in sections 12-14 and the Public and Privacy Act (2009: 400) apply.
Healthcare professionals should pay particular attention to a child's need for information, counseling and support for the child's parent or any other adult the child lives permanently with -
1. has a mental disorder or mental disability, 
2. has a serious physical illness or injury, or 
3. are addicts of alcohol or any other addictive agent.
The same applies if the child's parent or any other adult the child lives permanently with unexpectedly dies.
Provisions concerning the obligation to report to the Social Council that a child may need the protection of the committee is contained in Chapter 14, Section 1 of the Social Services Act (2001: 453). Team (2017: 62) .
Section 6 The person responsible for the health care of a patient shall ensure that the patient and his or her family are given information in accordance with Chapter 3. patient layers (2014: 821). Team (2014: 828) .
Section 7 The person responsible for the health care of a patient shall contribute to the patient being given the opportunity to choose treatment options and aids for persons with disabilities as specified in Chapter 7. 1 and 2 of the Patients Act (2014: 821).
The person responsible for the health care of a patient shall contribute to the patient receiving a new medical assessment as specified in Chapter 8. Section 1 of the Patient Act.
This section does not cover dental care according to the Dental Care Act (1985: 125). Team (2014: 828) .
Section 8 If a patient has died, the healthcare personnel shall perform their duties with due respect for the deceased. Associates should be given consideration and consideration.
Section 9 A doctor or dentist employed in the public health service is required to, to the extent that other duties in the professional activity do not prevent it or there are no special reasons for doing so, conduct investigations and give statements on them on request by county administrative board, court, prosecutor's office, police authority or supervisor.
A physician active in the public health care sector is obliged, at the request of the police, to insofar as other duties in the profession do not prevent it or there are no special reasons for doing so, conduct a survey involving the physical examination of someone who is suspected of a crime that may impose a custodial sentence.
The limitation of the obligation to conduct investigations and to give statements does not apply to doctors who are mainly active in open-minded care and, in the case of examination and opinion on alcoholic influence, neither to any other physician.
The Act (2005: 225) on Criminal Matters contains specific provisions on statements in some cases. Team (2014: 888) .
Section 10 Any person who, in his occupational health care profession, issues a certificate of health or care, shall design it with care and care.

Notification obligation for healthcare professionals who administer medicines

Section 11 If a prescription of a narcotics drug, other special medicines, alcoholic drugs or technical liquor by a legitimate professional may reasonably be contravened with science and proven experience, the healthcare professional who administers drugs must report this to the Health and Social Care Inspectorate.
The government or government authority determined by the government may issue regulations on what is meant by specific drugs. Team (2012: 957) .

Confidentiality, etc.

Section 12 The person belonging to or belonging to healthcare professionals within the health care sector may not disclose the unauthorized person what he or she has learned about an individual's state of health or other personal circumstances. As unauthorized disclosure, no person is deemed to fulfill such disclosure obligations as provided for by law or regulation.
Confidentiality that applies to a patient's health condition also applies in relation to the patient himself, if it is of particular importance that the task is not given to the patient in view of the purpose of health care.
For the public's activities, the Public and Privacy Act (2009: 400) applies.
Section 13 Any person belonging to or belonging to healthcare professions in the individual health care service may not disclose to an unauthorized person a statement from an individual about the health status or other personal circumstances of another person, if there is a risk that the who has left the task or any related person to the reporting provider is subjected to violence or other seriously but if the task is void. As unauthorized disclosure, no person is deemed to fulfill such disclosure obligations as provided for by law or regulation.
For the public's activities, the Public and Privacy Act (2009: 400) applies.
Section 14 The person belonging to or belonging to healthcare professionals in the individual healthcare service may not disclose or use such information on the manufacture or content of a particular product which he or she has received in the business and has been provided there for use as an information or basis for treatment or other similar measure. As unauthorized disclosure, no person is deemed to fulfill such disclosure obligations as provided for by law or regulation.
For the public's activities, the Public and Privacy Act (2009: 400) applies.
Section 15 Except as otherwise provided by law or regulation, healthcare professionals are obliged to disclose such information as
: 1. Whether a person resides in a medical care institution if the information in a particular case is requested by a court, a prosecutor's office, the police authority, the security police, Enforcement Authority or the Swedish Tax Agency,
2. needed in the business for personal protection for members of parliament, Head of State and other members of the royal family, cabinet ministers, minister of State and cabinet Secretary, if the data in a particular case requested by the Security Service, the
third is needed for a forensic examination,
4. National Board advice for some legal, social and medical issues need for their business,
5. is required for examining a case to separate a student from college education or the police program; or 
6. is required to test someone's aptitude to have driving license, tractor card or taxi driver identification under the Tax Law Act (2012: 211). Team (2014: 768) .
Section 16 Any person who, without consulting the healthcare staff, as a result of employment or assignment or on other similar grounds, participates in or has participated in an individually managed health care, may not disclose to an unauthorized person what he or she has learned about an individual's health condition or other personal circumstances. As an unauthorized disclosure, no person is deemed to be required to fulfill the obligation to provide information pursuant to law or regulation.
For the public's activities, the Public and Privacy Act (2009: 400) applies.

Authorization

Section 17 The government or government authority determined by the government may issue regulations on the obligations of healthcare professionals necessary for the protection of human life, personal safety or health.

7 chap. Inspection for Care and Care Supervision

General provisions

Section 1 Healthcare and its personnel are supervised by the Inspectorate for Care and Care.
The health service within the Armed Forces and the Defense Material Workshop is supervised by the Defense Inspector for Health and the Environment. The Government or the authority determined by the Government may, pursuant to Chapter 8, Section 7 of the Government Form shall issue regulations on this supervision. Team (2017: 786) .
Section 2 Any person who, without carrying on healthcare, receives health services from a sample, analysis or other investigation which forms part of the assessment of a patient's health or treatment, is also under the supervision of the Inspectorate. for care and care. Team (2012: 957) .
Section 3 Supervision pursuant to this Act means that the activities and staff referred to in sections 1 and 2 meet the requirements and objectives of laws and regulations as well as decisions issued pursuant to such regulations.
Supervision shall focus primarily on review that the healthcare provider fulfills its obligations under Chapter 3.
Provisions under sections 20 and 24 and prohibitions under sections 26-28 may be used only when the activities do not comply with the requirements of laws and regulations.
Section 4 The Health and Care Inspectorate shall, within the framework of its supervision,
1. Provide advice and provide guidance,
2. Verify that deficiencies and maladministration are remedied,
3. Provide knowledge and experience gained through supervision, and
4. Inform and advise the public . Team (2012: 957) .
4a § / Entry into force: 2018-01-01 / The Health and Safety Inspectorate shall, in the context of its supervision, consult patients and their relatives on the conditions under which they are supervised, unless this is inappropriate or unnecessary. Team (2017: 378) .
Section 5 When supervising children's circumstances, the child may be heard if it is assumed that the child does not hurt the conversation. The child may be heard without the custodian's consent and without the custodian being present.
Section 6 / Termination valid for U: 2018-01-01 / The Inspectorate for Care and Care shall systematically retrieve information provided by Patient Committees pursuant to Section 4 of the Act on Occupational Disability Act (1998: 1656), etc.Act (2012: 957) .
Section 6 / Entry into force: 2018-01-01 / The Care and Care Inspectorate shall ensure that patients' experience is continuously used as a basis for decision-making on the purpose of supervision.
The inspection shall continuously cooperate with the patient boards and systematically retrieve information provided by patients' disputes pursuant to section 7 of the Act (2017: 372) on support for complaints against health care. Team (2017: 378) .
Section 7 The Health and Care Inspectorate supervises the safety of healthcare facilities where care is provided under the Act (1991: 1128) on psychiatric care or the law (1991: 1129) on legal psychiatric care and in units of legal psychiatric examination.
The government or government authority determined by the government may issue regulations on safety and safety classification of healthcare facilities and entities referred to in the first subparagraph. Team (2012: 957) .

Notifications from healthcare provider

Section 8 The Care and Care Inspectorate shall ensure that events notified to the Authority in accordance with Chapter 3, Section 5 has been investigated to the requisite extent and that the healthcare provider has taken the necessary measures to achieve high patient safety.
The first paragraph also applies, as appropriate, to notifications under Chapter 3. Section 6. Team (2012: 957) .
Section 9 The Health and Care Inspectorate shall disseminate information to healthcare providers and relevant authorities about events that have been reported to the Authority in accordance with Chapter 3. Section 5, and otherwise take the measures motivated by the notification to achieve high patient safety.
The first paragraph also applies, as appropriate, to notifications under Chapter 3. Section 6. Team (2012: 957) .

Complaint

Section 10 / Termination valid for U: 2018-01-01 / The Inspectorate for Care and Care shall, after notification, review complaints against the health care and its personnel. Team (2012: 957) .
Section 10 / Entry into force: 2018-01-01 / The Health and Care Inspectorate shall, after notification, review complaints against the health services and its personnel.
The application may be made by the patient in question or, if the patient is unable to report the matter, a relative to him or her. Team (2017: 378) .
Section 11 / Termination valid for U: 2018-01-01 / The Health and Care Inspectorate shall carry out the investigation necessary for the purpose of examining the complaint. The Authority may investigate and investigate circumstances that have not been invoked in the notification. Team (2012: 957) .
Section 11 / Entry into force: 2018-01-01 / The Care and Care Inspectorate shall, if the concerned healthcare provider has been given the opportunity to fulfill its obligations under Chapter 3. 8b § investigate complaints relating to
: 1. bodily or psychological injury or illness arising from healthcare which is permanent and not invalid or has led to a significantly increased need for care or death;
2. compulsory care according to The Act (1991: 1128) on psychiatric care or the law (1991: 1129) on legal psychiatric care or isolation under the Prison Protection Act (2004: 168), and
3. healthcare events seriously and negatively affected or threatened patient self-determination, integrity or legal status.
The Inspectorate for Care and Care may investigate complaints even if the conditions in the first paragraph are not met.
Complaints referred to in the first paragraph 2 need not be investigated if 
: 1. the complaint is manifestly unfounded; 
2. the complaint is of direct relevance to patient safety and there is no reason to consider a duty to report pursuant to section 23 or section 29; or 
3. it is a decision that is possible appeal by virtue of any of the laws referred to in the first paragraph.
The Inspectorate for Care and Care may refrain from investigating complaints if the event is more than two years back in time. Team (2017: 378) .
Section 12 / Suspension of U: 2018-01-01 / The Health and Care Inspectorate may refrain from investigating a complaint about
1. It is obvious that the complaint is unjustified, or
2. The complaint is of direct relevance to patient safety and there are no reasons to consider duty notification pursuant to section 23 or 29.
The Inspectorate for Care and Care shall not investigate events that last more than two years in the absence of special reasons. Team (2012: 957) .
Section 12 / Coming into force I: 2018-01-01 / If the care provider has not been able to fulfill its obligations under Chapter 3, 8b §, the Inspectorate for Care and Care may hand over the complaint to the healthcare provider or the patient board. Team (2017: 378) .
Section 13 / Suspension of U: 2018-01-01 / If a complaint concerns shortcomings in the contact between a patient and healthcare staff or any other similar relationship within the activities referred to in section 1 of the Act on Occupational Disability Affairs (1998: 1656) , the Health and Care Inspectorate may hand the complaint to the affected patient committee for action. However, only if the conditions in section 12 for non-investigation of the complaint are met. Team (2012: 957) .
Section 13 / Entry into force: 2018-01-01 / The Health and Care Inspectorate shall carry out the investigation necessary to review the complaint. The Authority may investigate and investigate circumstances that have not been invoked in the notification. Team (2017: 378) .
Section 14 Complaints should be notified in writing. The notification should state
: 1. the healthcare provider or healthcare personnel to which the complaint is addressed,
2. the event to which the complaint relates,
3. the date of the event, and
4. the name and address of the notifier.
Section 15 / Termination valid for U: 2018-01-01 / The Health and Care Inspectorate shall transmit the notification as soon as possible and, if applicable, the documents attached to the notification to the healthcare provider or healthcare personnel to whom the complaint is directed or may be considered directed against.
The first paragraph does not apply if the Inspectorate for Care and Care determines the case under section 12. Team (2012: 957) .
Section 15: Entry into force 2018-01-01 / If the Inspectorate for Health and Care is initiated by a complaint, the Authority shall promptly submit the notification and, if applicable, the documents attached to the notification to the healthcare provider or health and healthcare professionals whose complaints are directed against or may be considered to be directed against. Team (2017: 378) .
Section 16 / Suspension of U: 2018-01-01 / The person to which the complaint relates, the patient and, if the patient has not been able to report the matter, a relative to him or her, has the right to know what has been added to the case and shall, before deciding on the matter, be given the opportunity to share and comment on what has been added to the matter.
If the complaint concerns healthcare professionals, the affected healthcare provider should be heard in the case, unless it is obviously unnecessary.
The notification obligation does not apply if the Inspectorate for Health and Care issues determines the matter under section 12.
The right to receive information and the duty to notify is subject to the restrictions set out in Chapter 10. Section 3 of the Public and Privacy Act (2009: 400). Team (2012: 957) .
Section 16 / Entry into force: 2018-01-01 / The person to which the complaint relates, the patient and, if the patient has not been able to report the matter, a relative to him or her, has the right to know what has been added to the case and shall, before deciding on the matter, be given the opportunity to share and comment on what has been added to the matter.
If the complaint concerns healthcare professionals, the affected healthcare provider should be heard in the case, unless it is obviously unnecessary.
The notification obligation only applies if the Inspectorate for Care and Care has initiated an investigation of the complaint.
The right to receive information and the duty to notify is subject to the restrictions set out in Chapter 10. Section 3 of the Public and Privacy Act (2009: 400). Team (2017: 378) .
Section 17 The Health and Care Inspectorate shall, when transmitting documents for the opinion, specify the time within which the opinion shall be submitted to the Authority.
The person who is given an opportunity to comment shall be informed that the matter may be resolved even if no opinion is received within the prescribed time.
The procedure of the Inspectorate for Care and Care is in writing. If it appears appropriate from the investigative point of view, the Authority may obtain information orally in a matter. Information obtained orally and relevant to the investigation shall be documented. Team (2012: 957) .
Section 18 / Expiry of U: 2018-01-01 / The Inspectorate for Care and Care shall determine the complaints cases under this Act by decision.
In such a decision, the Health and Safety Inspectorate may decide whether an action or failure of healthcare professionals or healthcare professionals is in violation of law or other regulations or is inappropriate for patient safety. Such a decision may not be taken without the notifier and the party to whom the complaint relates has been given an opportunity to comment on a proposal for a decision on the matter.
The inspection for the care and care decision must be in writing and include the reasons for the decision. The decision shall be sent to the notifier, the party to whom the complaint relates and the relevant healthcare provider. Team (2012: 957) .
Section 18 / Entry into force: 2018-01-01 / The Inspectorate for Care and Care shall determine the complaints cases under this Act by decision.
If a complaint has been made, the Inspectorate for Health and Care shall declare whether an action or omission by healthcare providers or healthcare professionals is in violation of law or other regulations or is inappropriate for patient safety. Such a decision may not be taken without the notifier and the party to whom the complaint relates has been given an opportunity to comment on a proposal for a decision on the matter.
The inspection for the care and care decision must be in writing and include the reasons for the decision. The decision shall be sent to the notifier, the party to whom the complaint relates and the relevant healthcare provider. Team (2017: 378) .

initiatives Issues

Section 19 If the Inspectorate for Care and Care on its own initiative initiates an investigation against a healthcare provider or against healthcare professionals, the person concerned by the investigation shall be given the opportunity to submit an opinion. However, the inspection does not need to hear a patient affected by the investigation unless there is reason for it.
Before determining a case, the healthcare provider or healthcare professionals who are the subject of an investigation shall be given an opportunity to comment, unless obviously unnecessary. Otherwise, Section 12, second paragraph, Section 17 and, where applicable, Section 18 shall apply. Team (2012: 957) .

Common provisions on the Inspectorate for Care and Care

Section 20 The supervised person under this chapter and healthcare professionals are required to submit to the Inspectorate for Care and Care, requests, samples and other material relating to the business and provide information about the activities that the inspection needs for its supervision.
The Health and Safety Inspectorate may instruct the operator or healthcare staff to submit what is requested. A decision on injunction may be combined with a fine. Team (2012: 957) .
Section 21 / Termination valid for U: 2018-01-01 / The Inspectorate for Care and Care, or the person appointed by the inspection, is entitled to inspect the activities under the supervision of this chapter and the professional activities of the healthcare professionals. The person who performs the inspection is entitled to access premises or other spaces used for the business, but not housing. The person who performs the inspection is entitled to temporarily dispose of documents, samples and other material relating to the business. The person whose activity or professional activity is inspected is required to provide the necessary assistance at the inspection. Team (2012: 957) .
Section 21 / Entry into force: 2018-01-01 / The Inspectorate for Care and Care, or the person appointed by the inspection, is entitled to inspect the activities under the supervision of this chapter and the professional activities of the healthcare professionals. An inspection may be notified or unannounced. The person who performs the inspection is entitled to access premises or other spaces used for the business, but not housing. The person who performs the inspection is entitled to temporarily dispose of documents, samples and other material relating to the business. The person whose activity or professional activity is inspected is required to provide the necessary assistance at the inspection. Team (2017: 378) .
Section 22 In the case of an inspection referred to in Section 21, the inspector is entitled to receive the assistance required by the police authority for the purpose of the inspection.
Such assistance may only be requested for 
: 1. Due to special circumstances, the action can not be carried out without the special powers of a police pursuant to Section 10 of the Police Act (1984: 387), or 
2. There are other special reasons. Team (2014: 768) .

Measures against caregivers and others

Section 23 If the Inspectorate for Care and Care becomes aware that someone has violated a provision relating to activities under the supervision of the Inspectorate, the Authority shall take steps to comply with the provision and, if necessary, make a notification of prosecution. The same applies if someone who does not belong to healthcare professionals has violated any of the provisions in Chapter 5. 1 § 1-7. Team (2012: 957) .
Section 24 If the Inspectorate for Care and Care finds that a healthcare provider or entity referred to in Section 7 does not fulfill its obligations under Chapter 3, and if there are grounds to suspect that the failure causes patient safety or safety to others, the inspection shall instruct the healthcare provider or the entity to discharge its obligations if it is not obviously unnecessary. A decision on injunction may be combined with a fine. This also applies to activities referred to in Section 2 if the activities are at risk for patient safety. Team (2012: 957) .
Section 25 An injunction pursuant to section 24 shall contain information on
: 1. the measures deemed necessary by the Inspectorate for Care and Care for the remedies to be remedied, and
2. when the measures are to be carried out by the end. Team (2012: 957) .
Section 26 If an injunction pursuant to Section 24 is not complied with and if the misconduct poses a danger to patient safety or otherwise is of a serious nature, the Health and Care Inspectorate may decide to ban all or part of the activity.Team (2012: 957) .
Section 27 If there is a significant danger to patients' lives, health or personal safety in general, the Inspectorate for Care and Care, without prior notice, may decide to ban all or part of the activity. Team (2012: 957) .
Section 28 If there are likely reasons for the operation to be prohibited in whole or in part pursuant to sections 26 or 27 and such a decision can not be waived, the Health and Care Inspectorate may decide to completely or partially prohibit the activities until further notice.
Such a decision is valid for a maximum of six months. If there are special reasons, the validity of the decision may be renewed once for another six months. Team (2012: 957) .

Measures against healthcare professionals

Section 29 If the Health and Safety Inspectorate becomes aware that healthcare professionals do not fulfill their obligations under this Act or any other provision applicable to healthcare activities, the Inspectorate shall take steps to ensure that the obligations are met.
If healthcare professionals are reasonably suspected of having committed a crime for which prison is prescribed in the profession, the Inspectorate for Care and Care shall, subject to Chapter 9, Section 17, make an application for prosecution.
In Chapter 8, Section 3, second paragraph, the Genetic Integrity Act (2006: 351), contains special provisions that general prosecution for certain crimes may be brought only after the consent of the National Board of Health. Team (2012: 957).

Measures against legitimate healthcare professionals

Section 30 If the Inspectorate for Care and Care considers that there are grounds for decision-making on probation periods, revocation of identification, revocation of other qualifications for occupational health care or limitation of prescription rights under Chapter 8, the inspection shall report this to the Health- and the health services board. Team (2012: 957) .

8 ch. Trial period and revocation of identification, etc.

Probationary

Section 1 A trial period of three years shall be decided for the person who has a license to practice a profession in the health care sector, if the legitimate person
1. has been unfair in the exercise of his occupation and the ignorance may be considered to be of importance to patient safety;
2. in or in in connection with professional practice has committed crimes committed to affect him / her,
3. intentionally or negligently has violated any provision that is essential to patient safety, or
4. due to other circumstances, may be claimed to be inappropriate to practice the profession.
Probation times shall also be decided if it is considered that a licensed professional because of illness or similar circumstance will not be able to exercise his profession satisfactorily.
If there are special reasons, decision-making time may be omitted.
Section 2 In a probation decision, a plan shall be laid down by the legitimized if such a probation schedule is deemed to be of significance in order to overcome the misconduct that gave rise to the decision on probation. Proposals for a trial schedule are prepared by the Inspectorate for Care and Care, if possible in consultation with the legitimized.
The government or the authority determined by the government may issue regulations on the measures or conditions that may be included in such a plan. Team (2012: 957) .

Revocation of ID

Section 3 Identification of a profession in the health care sector shall be revoked if the legitimate person
1. has been grossly unfair in exercising his or her occupation;
2. in or outside the occupation has committed a serious crime committed to affect the trust of he or she, or
3. has otherwise been shown to be incapable of exercising the profession.
If there are special reasons in the cases referred to in the first paragraph 2, revocation may be omitted.
4 § Papers should also be withdrawn if the registered
first because of illness or some similar circumstance can not practice the profession satisfactory,
2. has been granted probation under § 1, first paragraph and during the probation period again proved unfit to practice his profession,
third has been notified probation time with a trial schedule and failed to comply with the plan; or
4. requests that the credentials be revoked and there are no barriers to recall from a public point of view.
If there are special reasons in the cases referred to in the first subparagraph 2 or 3, revocation may be omitted. If revocation is refused, trial period may be decided once more.
Section 5 has been repealed by law (2016: 150) .
Section 6 If there are probable grounds for revocation in a case pursuant to section 3, first paragraph or section 4, first paragraph 2 or 3, the credentials shall be revoked until the question of revocation has been finalized. However, this only applies if it is necessary to ensure patient safety or else it is necessary from a public point of view.
A decision pursuant to the first paragraph shall apply for a period not exceeding six months. If there are special reasons, the validity of the decision may be renewed once more for a further six months.
Section 7 If there is reason to believe that a revocation is required pursuant to section 4, first paragraph, the authorized professional may be ordered to be examined by the doctor appointed by the Health Service.
If a medical examination order has been decided, the identification must be revoked until the issue of revocation has been finalized. However, this only applies if it is necessary to ensure patient safety or else it is necessary from a public point of view.
If the registered professional has not followed an injunction for medical examination within one year of receiving the injunction, the credentials may be revoked.

Revocation of other privileges

Section 8 Other jurisdiction to pursue a profession in health care than the certificate issued under Chapter 4 shall be revoked if the person entitled
1. has been unfair in exercising his or her occupation;
2. in or outside of the profession has been guilty of to a serious crime committed to affecting him or her confidence, or
3. has otherwise proved inappropriate to exercise the profession.
Revocation shall also take place if the person who has obtained the qualification can not exercise the profession satisfactorily due to illness or similar circumstance.
Section 9 If there is reason to assume that the jurisdiction shall be revoked pursuant to Section 8, the jurisdiction shall be revoked until the issue of revocation has been finalized. However, this only applies if it is necessary to ensure patient safety or else it is necessary from a public point of view.

Limitation of prescription rights

Section 10 If a doctor or dentist has abused his / her ability to prescribe narcotics, other special medicines, alcoholic drugs or technical spirits, this authorization shall be withdrawn or restricted. The authorization should also be withdrawn or restricted if your doctor or dentist so requests. Team (2014: 828) .
Section 11 If there are probable grounds for suspicion of such abuse of prescription rights as referred to in section 10, the jurisdiction shall be withdrawn or limited until the question of termination or limitation of jurisdiction has been finalized. However, this only applies if it is necessary to ensure patient safety or else it is necessary from a public point of view.
A decision pursuant to the first paragraph shall apply for a period not exceeding six months. If there are special reasons, the validity of the decision may be renewed once more for a further six months.

New identification, etc.

Section 12 If a credential has been revoked or an authorization to prescribe narcotics, other special medicines, alcoholic drugs or technical liquor has been withdrawn or restricted, a new ID or authorization shall be issued upon application, subject to the requirements of Chapter 4. are met. Team (2011: 1190).

Competent authority

Section 13 The Health Services Board of Appeal examines questions under this chapter.

9 ch. Healthcare Responsibility Board

Composition and decision-making, etc.

Section 1 On notification of the Inspectorate for Health and Care, the Health Services Board of Health examines the matters referred to in Chapter 8, 1-11 §§.
At the request of the practitioner the matter applies to the Board of Appeal the questions referred to in Chapter 8. Section 1, Section 4, first paragraph 4, and sections 10 and 12.
Provisions for the right of the Ombudsman for the Riksdag and for the Registrar of Justice to make a notification in cases referred to in the first paragraph are contained in Section 6, third paragraph, of the Act (1986: 765) with instructions for the Ombudsman of the Riksdag and in Section 6, first paragraph, of the Act (1975: 1339) supervision. Team (2012: 957) .
Section 2 The Board of Responsibilities consists of one chairman and eight other members.
For the chairman one or more vice chairpersons shall be appointed. For each other member there must be a sufficient number of substitutes. Team (2016: 519).
Section 3 The Responsibility Board is decided with the chairman and at least six other members. At a meeting with the Board, all members shall be called. If a member notifies a barrier, a replacement shall be called.
Section 4 The chairman may make a decision
1. which does not include final decision in substance, but no decision for injunction to undergo a medical examination under Chapter 8. Section 7, first paragraph, or temporary revocation of identification or jurisdiction pursuant to Chapter 8, Section 6, Section 7, second paragraph, section 9 or section 11;
2. revocation on own request of credentials or jurisdiction in cases where there are no barriers to revocation;
3. revocation of credentials under Chapter 8; Section 7, third paragraph, when the legitimized did not follow the order for medical examination, or
4. if notified pursuant to Section 18.
Cases decided in accordance with the first paragraph shall be notified at the next meeting with the Board. Team (2016: 150) .
Section 5 In the case of disqualification against the person handling cases in the Board of Appeal, the provisions of Chapter 4, the trial of jail against judges is applied.
Section 6 In the case of voting in the Board of Appeal, the provisions of Chapter 29, The Code of Conduct on Judgment in Courts with Only Legislative Members Applied. The chairman makes his opinion first.

The proceedings in the Board of Appeal

Section 7 A notification to the Board of Appeal shall be made in writing and contain information of
1. whose notification concerns and details of his occupation, address and workplace,
2. what is required in the case, and
3. the circumstances relied on in support of the notification.
The notifier shall also submit the investigation made in the case.
If a party is represented by a representative, proxy shall be submitted.
Section 8 An application to the Board of Appeal shall be made in writing and shall be signed in its own right and shall contain information on
: 1. the applicant's name, social security number and postal address;
2. what is required in the case; and
3. the facts relied on in support of the application.
If a party is represented by a representative, proxy shall be submitted.
Section 9 If a notification or application is so insufficient that it can not be used as a basis for a substantive examination, the Board of Appeal shall order the notifier or the applicant to submit supplementary information within a certain period of time. In the order it must be noted that the case is not inadmissible.
Section 10 The procedure is in writing. Oral negotiations may, however, be deemed to be of benefit to the investigation.
Section 11 Notification and, where applicable, the attached documents shall be communicated as soon as possible to the party to whom the notification relates. The recipient must be submitted to reply within a certain time.
Submission and submission pursuant to the first paragraph is not necessary if it is clear that the notification can not be accepted or that the notification is unnecessary.
Section 12 The person who has been prepared to respond shall do so in writing, unless the Board of Appeal determines that the answer may be given in an oral hearing.
The answer will indicate if the respondent accepts or opposes the claimant's claim in the matter. If the defendant opposes the claim, he or she shall state the reasons for his attitude and the circumstances relied upon and, if applicable, file the documents referred to in the case.
Section 13 If a question requires special expertise, the Board of Responsibilities may obtain opinions from authorities and others with such special expertise.
In the case of experts, 40 chapters apply. Sections 2-7 and 12 of the Code of Conduct, applicable.
Those who are required to submit an opinion are entitled to compensation for their statement only if specifically provided.
Other experts are entitled to compensation of public funds for their assignment. The board may grant advances on such compensation.
Section 14 If the Board of Appeal finds that a witness or expert needs to be heard under oath or a party is heard under the guarantor's assurance or that someone is required to provide a written document or object as evidence, the board shall request that from the district court in whose area the person is staying which will be heard or otherwise affected by the measure.
If there are no barriers to it, the court shall hold a hearing or give notice. In the case of such measures, the applicable provisions shall apply to the taking of evidence in proceedings other than the main proceedings.
Section 15 For an oral hearing, the parties shall be called. A single party may be instructed to attend personally. In the order it must be stated that it does not prevent the case's further processing if he or she fails.
An individual party, who has agreed to an oral hearing, may be granted by the Board of Appeal a reasonable remuneration of general funds for travel and subsistence expenses. The board may grant advance payment.
The government announces detailed rules for compensation and advances.
Section 16 The provisions of sections 20 and 21 of the Administrative Act (1986: 223) shall also apply to decisions pursuant to Chapter 8 of the Act. Section 6, first paragraph, Section 7, first and second paragraphs, Section 9 and Section 11, first paragraph.

Application for prosecution

Section 17 The Board of Appeal finds in a case that there are conditions for notification of prosecution under Chapter 7. Section 29, second paragraph, the Board shall make such notification unless the Inspectorate for Care and Care has already reported the matter to prosecution. Team (2012: 957) .

Disclosure requirements

Section 18 On the Board of Appeal or a General Administrative Court under Chapter 8, decides on revocation of credentials, probationary period or withdrawal or limitation of prescription rights, the Board of Appeal shall decide to inform the competent authorities of other States of the European Economic Area (EEA) and Switzerland of the decision or judgment. The authorities shall be informed not later than three days after the date of the decision or judgment. If this decision or this judgment ceases to apply, the Board of Appeal shall without delay inform the competent authorities of other states in the EEA and in Switzerland.
Notifications under the first paragraph shall be made via the Internal Market Information System (IMI). Team (2016: 150) .

10 ch. Penalties and appeal, etc.

penalty provisions

Section 1 Anyone who intentionally or negligently commences, moves, or substantially changes an activity subject to supervision under this Act without having made the prescribed notification under Chapter 2, Section 1 or 2 shall be fined. Team (2013: 276) .
Section 2 Anyone who intentionally or negligently continues to conduct an activity contrary to a prohibition under Chapter 7, 26, 27 or 28 shall be sentenced to a fine or imprisonment for a period not exceeding six months.
Section 3 A physician whose identification has been revoked or whose jurisdiction has otherwise been terminated or restricted and who, as unauthorized and for compensation, exercises the medical profession, shall be sentenced to fines or imprisonment for a maximum period of six months.
Section 4 The unauthorized and reimbursed practitioner of the dental profession shall be sentenced to a fine or imprisonment for a period not exceeding six months.
As an unauthorized practice of dental practice, no professional activity is exercised by a person who has a dental hygienist or who has the required qualifications as a dental hygienist or dentist.
Section 5 Anyone who contravenes any of the provisions of Chapter 4, 3, 5 or 6 shall be sentenced to a fine.
Section 6 To a fine or imprisonment for a maximum of one year, it
shall be deemed to be a violation of one of the provisions of Chapter 5. 1 § 1-7, or
2. under the exercise of activities mentioned in Chapter 5, Section 1 intentionally or negligently
(a) adds or treated a non-insignificant injury, or
b) causes danger of such damage.
The first paragraph 2 applies irrespective of whether the injury or danger has been caused by inappropriate treatment or by interruption or delay in medical treatment.
The fact that the offender has failed to realize the nature of the disease or to predict the injury or the danger does not release him or her from liability due to lack of education and experience.
If the offense is punishable by punishment pursuant to section 3 or 4, it shall instead be held liable under these provisions.
Section 7 Liability under any of the provisions of sections 3-6 shall not be judged if the act is subject to stricter penalty in another law.

Witnesses etc.

Section 8 If any person has committed a crime referred to in section 6, the Inspectorate for Care and Care may decide to prohibit him or her for a certain period of time or forever to pursue activities as referred to in Chapter 5, Section 1. Such a decision may be combined with knowing.
Anyone who contravenes such a prohibition of prohibition shall not be sentenced to punishment for acts covered by the prohibition of prohibition. Team (2012: 957).

Appeals against the decision of the Health Services Board

Section 9 The Board of Health's Board of Appeal's decision under this Act may be appealed to the General Administrative Court.
A test permit is required in appeal proceedings.
Section 10 Decisions of the Board of Appeal that do not mean that a case is settled may be appealed only in connection with appeal against the final decision in the matter.
However, a decision that is not final may be appealed, in particular, when the Board 
: 1. dismissed opposition to a member of the Board or objection to opposition; 
2. rejected a representative or assistant; 
3. ordered the matter in pending the decision being made; 
4. instructed anyone to undergo a medical examination under Chapter 8. Section 7, first paragraph, or 
5. Order for compensation for participation in the case.
Section 11 The final decision of the Board of Appeal may only be appealed against by the
Inspectorate for Care and Care for the Protection of General Interests, and
2. the Occupier to whom the decision is addressed.
Provisions for the right of the Ombudsman for the Riksdag and for the Registrar to appeal against a decision on probation or jurisdiction are contained in Section 7 of the Act (1986: 765) with instructions for the Ombudsman of the Riksdag and in Section 7 of the Act (1975: 1339) on the supervision of the Attorney General. Team (2012: 957) .
Section 12 Decision on matters referred to in Chapter 8 and 9 chap. Section 18 applies immediately, unless otherwise stated in the decision. Team (2016: 150) .

Appeal of the Inspectorate for the care and care and social welfare decision etc.

Section 13 The Inspectorate for Care and Care's decision may be appealed to the General Administrative Court if the decision concerns the
first order under Chapter 7. Section 20, second paragraph, to provide information, documents or other material;
2. Order under Chapter 7. Section 24 to make correction,
3. Prohibition under Chapter 7. Section 26, 27 or 28, or
4. prohibiting the pursuit of activities pursuant to section 8, first paragraph.
Other decisions of the Health and Care Inspectorate under this Act may not be appealed.
A test permit is required in appeal proceedings. Team (2012: 957) .
13 a § The National Board of Health's decision on identification or other jurisdiction under Chapter 4 may be appealed to the General Administrative Court.
Other decisions of the National Board of Health pursuant to this Act may not be appealed.
A test permit is required in appeal proceedings. Team (2012: 957) .
Section 14 Decisions that the Inspectorate for Care and Care and the National Board of Health notifies under this Act shall apply immediately, unless otherwise stated in the decision. Team (2012: 957) .

Handling in General Administrative Court etc.

Section 15 The Inspectorate for Care and Care is the counterparty of the professional who appealed against the final decision of the Board of Appeal or a court pursuant to Chapter 8. 1-12 §§. This applies, however, unless otherwise provided in Section 7, second paragraph, of the Act (1975: 1339) concerning the supervision of the Attorney General or Section 7, second paragraph, of the Act (1986: 765), with instructions for the Ombudsman of the Riksdag. Team (2014: 62) .
Section 16 If the execution of a decision on probationary term has been terminated or inhibited as a result of a court decision following an appeal, but thereafter a trial period shall be decided, only the period during which probationary time is in progress shall be included in the probationary period.
Section 17 Decisions by the Public Administrative Court pursuant to this Act shall apply immediately, unless otherwise specified in the decision.

Transitional

2010: 659 
1. This Act enters into force on January 1, 2011, when the Occupational Occupational Health Act (1998: 531) shall expire. 
2. Those who received a dental exam in accordance with the provisions in force prior to 1 July 1994 shall perform practical service in accordance with the provisions in force at this time in order to obtain a dental qualification. 
3. For cases of probation, revocation of credentials and other permissions or limitation of prescription right appealed to by the Health Services Board before 1 January 2011, the provisions of the repealed Act still apply. 
4. If trial time has been decided on the basis of the repealed Act, Chapter 5 still applies. Section 7, first paragraph, 4 of that Act.
5. The Health Board's Board of Appeal shall submit to the National Board of Health and Welfare the actions in the disciplinary proceedings initiated by the Board before 1 January 2011 and which have not yet been resolved. At the National Board of Health's handling of these cases, Chapter 7 applies. 10-18 §§ the new law. 
6. The repealed Act shall continue to apply for examination of disciplinary disciplinary proceedings following an appeal or by the Health Service Board of Appeal after referral from court.
2011: 1190
This law enters into force on January 1, 2012 but is applied for time from January 1, 2011.
2012: 957 
1. This Act shall enter into force on 1 June 2013. 
2. For the purposes of applying Section 7a of the Administrative Procedure Act (1971: 291), the Inspectorate for Care and Care shall be the counterparty of the individual if the inspection after the entry into force is authorized to handle that type of question under review. 
3. For acts referred to in Chapter 10, Paragraphs 1 and 2 and committed before the entry into force apply 2 chapters. Sections 1 and 2 and chapter 7 Section 26-28 in its earlier version. Team (2013: 276) .
2013: 1149 
1. This Act enters into force on 1 January 2014. 
2. Applications for identification as a physiotherapist who have been admitted to the National Board of Health before 1 January 2014 but have not yet been resolved shall apply as applications for identification as a physiotherapist. 
3. When applying for a certificate as a physiotherapist, the degree in physiotherapy shall be regarded as equivalent to a physiotherapist exam. 
4. Older provisions still apply to legitimate physiotherapists and for occupational physiotherapists.
2014: 62 
1. This Act shall enter into force on 1 March 2014. 
2. It shall also apply to decisions notified prior to the entry into force.
2017: 378 
1. This Act shall enter into force on 1 January 2018. 
2. For cases initiated by the Inspectorate for Care and Care before 1 January 2018, Chapter 7 applies. Sections 11-13, 15, 16 and 18 in the earlier version.