1 Still introduction As we have seen, drug regulatory affairs are governed either by laws or...

1

Still introduction

• As we have seen, drug regulatory affairs are governed either by laws or decisions of competent authorities

• We should be familiar how to handle them!

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How to read laws?

• The majority of rules governing drug affirs is written in pieces of law

• Inevitably we should consult one or more

• How to read them (not to miss what may be important)?

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Taking a piece of law in our hands...

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How to read it?

What should not be missed when reading a piece of law?

• its very beginning (Preamble)

• its definitions

• its legal power

• coming into force

• what is repelled or changed

Law

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“naturally”...

…the bulk of the law contains the specific provisions themselves, but these are, as a rule, read and studied…

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Preamble

• Act (higher piece of law): as a rule: the “philosophy” of the provisions

• Decree (lower piece of law): – the same or– only a reference to the

authorisation given by an Act (of Parliament)!

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Hungarian example for the Preamble 1

25th Act of 1998 on medicines for human use

“The Parliament, as a part of the State responsibility for the protection and restoration of human health as well as directed by the responsibility thereof, has adopted this Act:”

(Philosophy: “medicines are special (Philosophy: “medicines are special commoditiescommodities”!)”!)

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Hungarian example on the Preamble 2

Decree No 61/1999 (on 1st December 1999) EüM of the Minister of Health on the wholesaling activities with medicines

“On the basis of the authorisation given by Article 24 paragraph 2 f) of the 25th Act of 1998 on medicinal products for human use, I order as follows:”

In Hungary, singular first person must be used!

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Definitions in law 1“When applying this piece of law, (this

term) means (that)..”

It may be different in another pieces of law!

HEE-HAW! I do not understand

it!

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Definitions

There must be definitions of the most important terms in every law, for the same terms

• are used in the everyday life• may be used by another piece of lawin a different meaning!

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Definition: „drug”

• Do you know what a drug is?

• Surely you know!

• But try to define it…

• (The following slides are purely illustration of a process of finding the exact definition!)

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(Human) Drug• Any substance that treats or prevents disease in human beingsNot exact! Drugs do not treat 100% of the patients!• Any substance that may be used to treat or prevent disease…Not exact in English! „May” has double meaning: „maybe (or may

not be)” as well as „permitted”! If the latter, it suggests authorisation. If so, e.g. non-authorised substances could be advertised as drugs?!

• Any substance presented as having properties for treating and preventing…

Not enough! What is a disease? You have physiological functions that can be modified a little or considerably! Where start a disease? (To define disease in general is more problematic than to define drug!)

• Any substance presented as having properties for treating and preventing disease or restoring, correcting or modifying physiological functions…

Still problems! An artificial tooth or even a spectacle restores your body functions!

(continued)

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(Human) Drug(continued)• Any substance presented as having properties for treating… or

modifying physiological functions by exerting pharmacological, immunological or metabolic action…

Whoops! Tablets comprise more than a single substance (even more than one active principles possible!)

• Any substance or combination of substances… in human beings.But… We said „in human beings”. What about non-absorbed local

dermatologic drugs?• …used in or administered to human beings.Still incompelete! What about in vivo diagnostics?• Any substance or combination of substances presented as having

properties for treating or preventing disease, or restoring, correcting or modifying physiological functions, by exerting pharmacological, immunological or metabolic action, used in or administered to human beings, or to making a medical diagnosis.

O.K., but this definition is extremely complicated!• (GO TO HELL!)

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Other part of the law: its power

• What (e.g. what kind of products, activities) and who (e.g. what persons, institutions or authority) is regulated

• Sometimes divided: “The power of this [law] comprises the…” while “not this law is applied for the…”

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Example

• The law specifies duties of „healthcare professionals”

• You are advised to go to the „Definitions” part and check whether this term is defined.

• E.g., is a local „healer” a healthcare professional? If not, the duties of the former can not be imposed to him…

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Sometimes combined power and definition

“(2)… nutritives for special dietary needs are those [definition]…

(3) In the application of this Decree the products listed below are not taken as nutritives:

a) food as defined in the Act on food-staffes,

b) medicines.” Often, when the definitions give room for

interpretation!

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It should often be clarified:

Which are the products that the present law is not applicable to:

• those complying with another definition or

• those already qualified as another product type

(often other pieces of law should be consulted to decide!)

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Examples

• Drug: treats diseases• Food: has nutritive valueThen, in case of doubts, you should consult the

product characteristics: which of these two applies to the given product

• Drug: any product authorised as such• Food: any product qualified as suchThen your first task is to clarify whether did a

competent authority issue a „drug” authorisation or „food qualification” (provided the latter is needed at all)

• etc.

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Coming into force

It is specified at the end of the piece of law (under various headings). Many possibilities, sometimes tricky:

• E.g. “This law comes into force on the first day of the third month following its publication.”

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Coming into force and temporary decisions 1

“(1) This Act comes into force on 1st January 1999.

(2) Provisions of Article 7 paragraph 5 apply to submissions filed after this Act has come into force.

(4) Medicines authorised for marketing before this Act came into force provisions of Articles 11 and 12 apply from 1st January 2003.”

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What is repelled?

(“Deregulation”)

“This Decree comes into force on …, simultaneously Article 8 of the Decree No. 20/1972 (on 20 December 1972 EüM, (…) as well as the Decree No. 6/1988. (on 15 June) SZEM become invalid.”

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Sometimes only words become outdeted...

• Modifying Act: 70th Act of 2001 modifying [many Acts relating health-care]

• Article 42 para 1 … c): “in Article 11 para 1 of the MA the text ‘together’ becomes outdated”

• What is MA? You shuld find it in the text before! (Actually, it was specified in Article 13 of this modifying Act as the Medicines Act)

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Modification of sentences or single words is also possible

E.g. ‘…in Article 6 para 1 [of the Act on the establishment of new pharmacies] the word “establishment” is replaced by the words “personal concession authorisation”,… in Article 30 para 3-4 the “National Public Health Service” is replaced by “the Chamber”...’ Nightmare!

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Modifying laws

• As a rule, when there are changes, not the new law is issued but a modifying law

• Sometimes it creates very complicated situations

• It is advisable to take a closer look to it

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Modifying laws 1

• Single modifying laws E.g. “1st Act of 2001 on the modification of the 58th Act of 1997 on the economic advertising activities”

This is the simplest form. One should only take care that numbering of the modifying and modified Articles and paragraphs are different! After modification the new text is taken as the “original”!

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Modifying laws 2

So-called “salad law” modifying many laws at the same time

E.g., in Hungary, the 70th Act of 2001 modified not less than 7 Acts at the same time

It may happen in another countries

Difficult to handle

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Modifying laws 3

There may be also a very nasty legal technique, when the title of the modifying law is ambiguous (you must go through it to know what has modified actually) A Hungarian example: The 14th Act of 2002 „modifying certain laws in the field of pharmacy”

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Modifying laws 4

Even nastier: if it is not in the law-making plan of the Parliament, a modification may be put into another law, issued to rule a completely different issue

Extremely difficult to spot

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Conclusion

If you are in the position that you should check something in a piece of law (Act of Parliament or different Decree, Ordinance, etc.), you should consider the before mentioned carefully!

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(Public) Authority decisions

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New chapter• Not only laws but also authoritative

decisions regulate our professional life

• I.e. some activities with drugs need authorisation. You have applied for it. The authority either authorise or refuse it

• But such decisions may have formalities…

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Decision of a Public Authority

…….I decided that….

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Is it important?

• Yes, by all means!• You should identify the formal

requirements prevailing in your country!

• It is equally important if – you are a civil servant yourself (and

issue such decisions) or – a decision is made against you!

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Public authority decision 1

In many countries: if there are formality defects = you loose the case! USA crimes: “the murderer was not informed about his personal rights…”

• In some countries: singular 1st person

• Addressee and others to be sent - unambigously

• Is there a (general) deadline?

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Formal requirements of a public authority decision 2

• Reference to the authorisation to make this decision [exact reference to law, Article, paragraph]

• It should be clear that this is a public authority decision

• The content of the decision can be: authorisation or rejection or requesting additional data (deficiency letter)

As a rule, no more possibility!

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Formal requirements of a public authority decision 3

• In a democratic system legal remedy against it is always possible. It should be pointed out in the decision, e.g.

appeal to the (e.g. Minister) or

no appeal is possible but it may be challenged in the Court

In both cases “within a specified period of time”. As a rule, specified by a general law (e.g. the Civil Service Act)

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Formal requirements of a public Authority decision 4

• Signature (as a rule, the Head of the Authority or “for” if deputy or “on behalf of” - e.g. the Minister)

• Logo and in certain countries also stamp/seal

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Types of Community laws in the European Union

It is interesting to know!

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And the laws of the European Union (EU)?

• Co-existence of Community law and national law

• National law:– taken from Community directives

– if no Community law: Member States are empowered to issue national law

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And the laws of the European Union (EU)?

Community law-makers: • the EU Parliament and the EU Council (as a

rule, together)• the EU Commission (if supported by the 2/3

of the Member States in the Standing Committee)

Types of Community law:• Regulation issued in all Member States’

languages, coming at once into force• Directive every Member State must place it into

its legislation (+2-3 years)

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Characteristics of the EU legal techniques

• The “soft law” is very important

• Case law!

• No special features in the structure of laws

• Details will be discussed at the different regulated topics

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Perhaps it will be easier now to find our way in medicines regulatory affairs...

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New Chapter: the national pharmaceutical/Drug

legislation(Basics for Drugh Regulatory

Affairs

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Drug legislation forms the basis of regulatory affairs

WHO: it should be• comprehensive (to cover every relevant

issue)„„unregulated” issues „regulate themselves” in the unregulated” issues „regulate themselves” in the

worst way, as a ruleworst way, as a rule

• enforceable (if not: it is worse than no legislation)

people will get accustomed to say: „O.K., this is the regulation but the life is different” – actually no rule is obeyed

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Introduction of new drug legislation/regulation

• Different levels of development, in the order of priorities = what to cover

• Levels 1, 2, 3, 4 (WHO)

• Check your home country:– which level you are at?– is it functioning?

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Level 1 drug regulation, a)

• formulate the drug legislation• establish a drug regulatory authority• create mandatory licensing of drug

importers, wholesalers, retailers and dispensaries of healthcare facilities, both private and public

(continued)

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Level 1 drug regulation, b)

• create product inventory or simple „licensing by accepting”, e.g. based on registrations in selected countries

• control imports by defining points of entry, issue permit for all consignements, request batch certificates

• establish inspectorate for drug distribution channels

• test drug quality when needed (identify contract lab sources, e.g. in Universities)

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Level 2 drug regulation, a)

• revise and update the existing drug legislation

• develop licensing for local manufacturers• introduce more stringent drug registration

measures such as chemistry-pharmacy assessment for generics,

• request information from exporting countries (information for physicians and patients, etc.)

(continued)

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• start performing GMP inspections (see later)

• establish a national drug QC laboratory to perform standard chemical and physico-chemical tests

• Start post-marketing quality monitoring system

• establish a drug info system for the public

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Level 3 drug regulation, a)• revise existing laws and regulations• develop capacity to register also premises

and practices in pharmaceutical trade (wholesale distributors and retailers such as pharmacies)

• develop capacity to make full assessment of applications for registration (including animal tests and human clinical trial results)

• develop capacity to make complete pharmacopoeial physical and chemical analyses

(continued)

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Level 3 drug regulation, b

• develop capacity for post-marketing quality surveillance of all drugs

• establish post-marketing safety (side-effects) surveillance

• initiate local clinical trials of local drugs

• initiate control of drug promotion and advertising

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Level 4 drug regulation, a)• review existing legislation• maintain strong regulatory authority• introduce full assessment of all new

drug applications, incl. biologicals• introduce all types of inspections (see

later: inspetction of distributors and retailers, incl. pharmacies)

• develop QC Lab also for biological control tests

(continued)

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• initiate and promote drug research (with a view to local sources!)

• develop national drug info centre

• enter international collaboration (WHO, regional, etc.)

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General Health-care legislation and drug-specific legislation

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What should be identified in your (any) legislation:

• General health-care legislation and regulation (comprising also drug regulatory affairs) or

• also Drug-specific legislation, regulation (if any)

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What can we find...

...in the general health-care legislation?

(Some parts are not specific to, but may be valid to drug affairs, too!)

??

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General health-care legislation, 1

Standard terms:

PATIENT who uses the health-care services? Or the patient buying non-prescription drugs is taken as “consumer”?

HEALTH-CARE PROVIDER any definition? E.g. who was authorised for such services by [a named] authority?

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Are the patient rights defined?

E.g. right to receive any information needed for his/her health and deny giving such info any other person? (Important! Can a sickness be held in secret? E.g. sexually transmitted diseases and possible infecting persons…)

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• Patients’ right for relieving pain, equity in health-care services

• Patient’s right to choose the practitioner (except urgent cases), keep patient waiting only when there is no bed or the service may not be provided elsewhere (if any such clause)

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Patients’ right for dignity which may be restricted in life-threatening cases exclusively. E.g. keep him/her waiting when it is inevitable, naked when it is necessary for the examination, etc. “The Nurse calls him Bed number two” - sampling at doping test...

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Patients’ right for human relations visitors, also during the night in serious cases, father present at birth, priest

Patients’ right to leave the health-care facility, informing the doctor accordingly naturally, it is restricted for psychiatric patients…

Right for information (doctor’s name, diagnosis - if not rejected by the patient)?

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Right to accept/reject the treatment. Written or verbal (witnessed?) The same for invasive and non-invasive treatments? (Of course, accidents…) For mentally handycapped: legal representative(s) (sequence!)

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Patients’ right for keeping his/her personal data in secret

Only the necessary health-care personnel may be present when examined

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Non-conventional treatments - do they exist, defined? Physicians and/or traditional healers, where is the (is there a) borderline? NCT complimentary (additive) or alternative?

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Chinese reflex zone massage Mongolian samanism

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Only registered health-care professionals? Any Exemption? Mandatory membership in the professional bodies (e.g. Chamber)? Recognition of foreign diplomas? Mandatory documented postgraduate training (“continuous education”, “life-long learning”)?

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Any mandatory internal quality assurance system?

Any supervision, inspection (e.g. by the Ministry, local authorities)?

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Health-care professional legally required to provide primary treatment at the level may be expected from him/her? E.g. in case of urgency (also a pharmacist!)

Defined Public Service Liability (e.g. for a defined region): appointment to be on duty (also pharmacy!)

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Selection of diagnostic or treatment methods - at the doctor’s discretion? Or among the scientifically accepted ones exclusively?

May a doctordoctor reject a patient by directing him/her to another doctor? E.g. when it were violate the law or professional rules or when it is against his/her ethics or when the patient insults him/her (except it is the consequence of the sickness)

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May another health-care professional (not a doctor) reject the care of a patient? Same cases as before?

E.g. non-prescription, ephedrine-containing nasal drops drank/injected by young addicts in front of the pharmacy - serving them?

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Biomedical research on human beings. Only for health-care reasons? On the basis of previously authorised protocol? When only human trial is convincing? Informed patient/volunteer consent (written, verbal-witnessed)? Mandatory pre-clinical research? Specification of vulnerable subjects (children, pregnant and breast-feeding women, arrested, soldiers and other dependants, etc.)? - insurance needed? Gene manipulation?

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• Patient-foreigners - on the basis of reciprocal agreements (except urgent cases)

e.g. foreign prescriptions in the pharmacies• Only authorised export-import of human

organs and tissues (except blood and its products)

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Medicine-specific legislation, regulation

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The 1st to identify: which Act(s) and regulations?

• Medicines Act, MoH Decrees• Financial pieces of law? Drug pricing,

reimbursement, procurement• Legislation on drug manufacture and

distribution wholesalers, pharmacies• Customs, narcotics, psychotropic legislation? • Borderline products (with pharmaceutical

action) , traditional/alternative medicine?

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The 2nd to identify: who are the stakeholders?

• MoH (various names)

• Ministry of Finance? Trade?

• National Insurance and Regulatory Body (inside or outside of MoH)?

• National Institutions (Public Health inspectors, etc.)

• Official Committees?

• Professional Societies, Chambers, etc.?

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Public and private sector in drug affairs

• Do they exist?

E.g. Governmental drug procurement and distribution versus private factories, importers and distributors

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Health (WHO)

More than drugs and physicians!

• adequate sanitation

• safe water supply

• proper nutrition

• drugs: efficacy, safety, quality, cost-effectiveness (particularly in the primary health-care)

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Some specific drug issues

• availability (Q, S, E) versus IP rigths (Patent, Data Exclusivity)

• affordability (budgetary constraints)

• equity• rational use (resistance - essential drug

concept)

• Independent drug info for prescribers and dispensers

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WHO: drug = product + information

substance = drug (can not be taken)

this is still environmental waste (how to take it?)

regis-tered Drug

registered, approved patient and prescriber information = drug

Exam topics!

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Content of law and Public Authority decisions

Define and speak about different parts of law:• preambles of different sources of law• definitions• its legal power• coming into force• repelled and changed pieces of law

Discuss possible formalities of Public Authority decisions

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Content of Pharmaceutical Legislation• Levels of its development according to WHO• General health-care legislation

– who is „patient”, „health-care provider” (HCP)

– patients” rights (mention at least 5)

– non-conventional treatments (describe the situation in your country!)

– registration of health-care professionals (in your country?)

– defined Public Service Liability (e.g. mandatory on-duty service)

– rigths for rejecting patients

– patient-foreigners

• Medicine (drug) specific registration– what kinds of legislation may exist?

– issues to be regulated

– who are involved (the stakeholders)

– public and private sector (the situation in your country?)

– drug issues (availability, affordability, equity, rational use – define and discuss them

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1 Still introduction As we have seen, drug regulatory affairs are governed either by laws or...

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