Reference legislation on medicines

Regulators who wish to develop or amend regulation for their respective jurisdiction might wish not to start from scratch, but to learn from other jurisdictions. Therefore we present here some legislation on medicines / pharmaceuticals / drugs of different jurisdictions as models. The models have different degrees of complexity. We start with rather simple models and go up to the quite complex models.

Of course we are not sure that we identified “the best of all” legislation, the more so as we limited the exercise for practical reasons to legislation available in English. But we were selective. We recommend only less than one third of the legislation we have screened. Knowing about its imperfection, we still hope that the result provides some orientation for regulators investigating the pharmaceutical sector.

 

I. Six models – from simple to complex

1. Nepal

Nepal has an extremely light, but very systematic law on drugs. It concentrates on basic principles and the most essential aspects. We have not found any “lighter” legislation wherefore we list it here whilst having some doubts about whether such a low level of details can make it.

2. Azerbaijan

Azerbaijan has a relatively light, but still quite complete law covering all major aspects, from licensing of activities like manufacturing to distribution. The law contains also provisions on medicines themselves, the import and export thereof, publicity for medicines, the enforcing authority, penalties and liability. The only downside might be that the law is maybe too light in terms of substantial requirements and procedural provisions, opening thus room for manifold interpretative views or even corruption. However, we suppose that secondary regulation can easily fill-in the gap, provided that there is a regulatory empowerment therefore. Hence, the law which was adopted in 2006 can be recommended as a light and relatively complete model. Still we also recommend to check whether further empowerments both for fine-tuning regulation and administrative actions are needed.

3. Tanzania

The law of Tanzania is situated somewhere in between the still relatively light law of Azerbaijan and the very recommendable medium detailed law of Bhutan. Its special performance is to cover also food, cosmetics and medical devices, following thus the U.S. regulatory and administrative system. It also has some nice features like adequately detailed provisions on sample-taking and enforcement, presumptions as to the intended use “for human consumption” (110.I.), the protection of informants (sometimes also called “whistleblowers”, see 119.-41.), and the empowerment to publish the name and the address of offenders (120. – see our Manual for more information on the last two regulatory techniques).

4. Bhutan

Bhutan has an act and supplementing regulations that cover many aspects at an appropriate / medium level of detail. The law of Bhutan goes beyond the usual topics such as requirements for medicines, the import and export thereof, publicity for medicines, incident reporting, product recall, and penalties. The regulations are excellent in defining the roles of various committees, persons and institutes in a system which is based on a board and many committees. The regulations contain a range of specific provisions that can help greatly in practical terms, e.g. on simplified renewal or transfer of registrations from one person to the other. It is complete regarding administrative empowerments, sanctions and liability provisions. The regulations provide for a simplified procedure for medicines previously authorised by a group of foreign medicines agencies. This is a good feature for countries which have less than top-level technological competency. However, it should be ensured that a certain medicine or substance can already be banned or its licence be withdrawn if one of the foreign medicines agencies has done so (and not just when the last one of the group has done so) and that the foreign medicines agencies provide for updates on their bans and licenses. Altogether we find the law of Bhutan being top class for its structure, preciseness, moderate length, and completeness.

5. Iceland

The law of Iceland on pharmaceuticals is complete in so far it covers many product-specific needs.  At the same time, the law of Iceland is not overly lengthy and has no superfluous “add-ons”.

6. Canada

The Canadian Food and Drug Regulations are very complex and very precise, e.g. by indicating even minimum and maximum dosage of substances in medicines and detailed labelling requirements. Obligations of economic operators are also precisely defined. One particular feature that few other jurisdictions provide are the minimum and maximum dosage prescriptions. The Regulations are particularly appropriate to be partly normatively referred to or copied by jurisdictions that wish to build on a well-established system without necessarily disposing of broad domestic administrative and scientific competence. The Canadian Regulations are also to be recommended to jurisdictions which wish to orient their domestic economic operators towards the NAFTA market.

II. Further legislation worthwhile being studied for particular aspects:

7. Georgia

Georgia has the law with the most detailed regulatory and administrative empowerments and detailed requirements regarding persons involved in the processing of and trade with pharmaceuticals. The law contains some useful features like the specific provisions on license transfers for pharmacists from other jurisdictions. However, generally speaking, the law might be regarded as going slightly over the top. Therefore, we recommend it at best for completing.

8. Thailand

Thailand has almost as detailed provisions on the persons involved in the trade with pharmaceuticals as Georgia. These provisions are well structured. However, we cannot recommend it for other topics or aspects.

9. Namibia

Like the law of Bhutan, the law of Namibia has a medium level of detail and is excellent in defining the roles of various committees, persons and institutes. The law of Namibia contains a range of specific provisions that can help greatly in practical terms, e.g. provisions on the transfer of registrations from one person to the other, provisions on preferred selling of generic drugs, provisions empowering the disclosure of health relevant information and provisions permitting to declare certain medicines or substances as “undesirable”. However, the law of Namibia is less complete than the law of Bhutan wherefore it should be better used as an inspiration for complementing rather than as a basis for developing regulation.

10. New Zealand

The law of New Zealand and supplementing regulations contains extremely detailed and sub-divided empowerments and other over-detailed provisions. Furthermore, many provisions are country specific and not needed elsewhere. However, we recommend studying it in so far it shows how medical devices can easily be covered in the same act as pharmaceuticals. Furthermore, it contains the most detailed definitions and some nice features, e.g. provisions on how to procure samples, fine-tuned provisions on labelling and branding, storage conditions, and practical application forms.

11. Australia

Like Tanzania, Australia regulates in one strike on medicines, medical devices, cosmetics and food. Thus it follows also the U.S. regulatory and administrative model. Australia has a more complex system than Tanzania and is thus even more similar to the U.S. model.

12. Bangladesh

The law of Bangladesh contains extensive regulatory and administrative empowerments. It might be used as reference to verify whether the empowerments foreseen in draft regulation are complete.

Further regulation can be found by search engines (Country name + legislation + regulation + pharmaceuticals + medicines + drugs) or by the following link:

http://www.who.int/medicines/areas/quality_safety/regulation_legislation/ListMRAWebsites.pdf

III. Other links useful for developing or amending regulation on pharmaceuticals / medicines / drugs:

WHO: systematic information on what can be regulated with regard to pharmaceuticals/drugs/medicines: http://apps.who.int/medicinedocs/documents/s19583en/s19583en.pdf

Panamerican Health Organisation: systematic information on what can be regulated or what can be requested prior to registration / authorisation with regard to pharmaceuticals/drugs/medicines: http://www.paho.org/hq/index.php?option=com_docman&task=doc_view&gid=22484&Itemid=

International Harmonisation Forum: systematic information on what can be regulated with regard to pharmaceuticals/drugs/medicines: http://www.ich.org/home.html

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