The example legislative scheme is structured on the basis of certain assumptions.

Most small developing countries have only a few qualified health professionals and are thus compelled to assign a variety of functions and responsibilities to every available official. This is quite in contrast to the situation in developed countries, and even in developing countries with adequate health manpower, where there is always a group of officials - operating often within a hierarchical structure supported by advisers and committees - entrusted with regulatory responsibilities for different health care products or products with health implications such as drugs, food, devices, herbal medicines, cosmetics, pesticides, chemicals, narcotics, etc.

In the regulatory arena, it is customary to work through institutional mechanisms such as boards, committees or commissions consisting of several professionals. In countries without any regulatory system in place, members of a newly created mechanism will normally have to function almost on a day-to-day basis until most of the preliminary work is completed. With only a handful of qualified health professionals available to attend to all the functions in the Ministry of Health and even in the hospitals, it will be difficult for some of the small developing countries to ensure that such boards or committees will have even a quorum. Even if such boards or committees were to be created, it may well be that one or two officials will have to undertake most of the routine work.

This legislative scheme envisages the establishment of a Drug Regulatory Authority or of a Medicinal Products Board. The latter mechanism is appropriate particularly for those countries which are able to assign a sufficient number of personnel to serve on such a Board. In this event, provision can be made for the appointment of a Secretary to the Board.

The scheme applies only to “medicinal products’ (hereinafter referred to as medicinal products or as products). But there is flexibility to extend the scheme to cover other health-related products, if so desired. It may well be that some countries might wish to extend the same (or similar) control regimes as are applicable to medicinal products to other products such as devices, herbal medicines, food and cosmetics, with a few additional provisions and regulation-making powers.

The Drug Regulatory Authority or the Board will be the authority in charge of the day-to-day implementation of the Law. The legislative scheme provides for the creation of a small advisory committee to provide guidance on general or specific policy and other related issues. The nature and composition of the Board and the advisory committee depend essentially on the expertise available in the country and which can be mobilized for the purpose. For this reason, the size, composition and other details are not specified in the scheme itself, but left to be addressed in the regulations.

The control system provided for by the legislative scheme is structured around an “inventory’” of the medicinal products available in the country. Regulation is not possible unless information is available, at some point in time shortly after the law has come into operation, of available products (i.e. imported and/or manufactured).

The first step towards regulation of medicinal products is essentially the compilation of the inventory. Manufacturers and importers can be required, by law, to transmit to the Drug Regulatory Authority or the Board relevant information concerning the products placed on the market on or before a particular date (appointed date) as may be specified in an official publication such as the gazette.

Notification will have the effect of “provisional authorization/registration” for the product. Notified products will be listed in an inventory which will be published or made available for public inspection.

After the appointed date, a medicinal product in respect of which information had not been provided and which does not have the status of being provisionally authorized/registered may not be imported or manufactured without the written permission of the Drug Regulatory Authority or the Board, thus facilitating the exercise of control over the medicinal products currently on the market.

Provisionally authorized/registered medicinal products listed in the inventory will be subjected to a rapid screening process, primarily to secure the withdrawal of those products that do not meet admissible standards of quality, safety and efficacy. The definitive assessment of provisionally authorized/registered medicinal products will have to be planned in accordance with established priorities.

New products (i.e. those not provisionally authorized/registered) may be imported or manufactured only with the prior written permission of the Drug Regulatory Authority or of the Board. Products which are the subject-matter of applications, after the appointed date, for their import or manufacture, will be subjected to technical assessment before a product authorization/licence is granted.

While the proposed legislative scheme is primarily concerned with controls in respect of medicinal products that are being imported or manufactured or sought to be imported or manufactured, the scheme provides for controls in respect of products for export as well.

Modern information technology, using desk-top computers, facilitates the recording, updating and retrieval of information and entries. In the not too distant future it should be possible to access regulatory information provided by selected regulatory authorities and by relevant international organizations such as WHO.

As regulatory decisions affect the interests of parties involved in manufacture, import, export or distribution, the legislative scheme provides for a right of appeal to the Minister or to another Administrative Authority against any decision of the Drug Regulatory Authority or the Board. The Minister or such other Authority may, upon considering the facts of the case, decide to affirm, modify, or rescind the decision of the Drug Regulatory Authority or the Board or to refer it to the Drug Regulatory Authority or the Board for reconsideration. The right of appeal to the Minister or to another Administrative Authority is an administrative safeguard, as an aggrieved person will always have the right to appeal to a court of law, in accordance with the general laws of the country. As the decision of the Minister or of such other Authority will be subject to scrutiny, subject to applicable legal principles, the Minister or the Authority will be expected to bring to bear on the decision an objective and unbiased perspective based on sound policy, scientific knowledge and the particular facts of the case. Courts of law are not normally concerned with technical decisions determined by those with the necessary scientific or technical experience and skills.

Critical to the success of the approach on which this legislative scheme is based is maximum use, through the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce, of regulatory information in respect of individual medicinal products available through drug regulatory authorities. Regulatory information disseminated by the World Health Organization will also be of particular value in this context (see Appendix 2).

Besides regulating medicinal products, the legislative scheme also provides for regulating - through a auhtorization/licensing system - those who manufacture, import, export, store, dispense or distribute medicinal products. The scheme provides for regulations to be made to specify who may be eligible for authorizations/licences and the procedures for applying for such authorizations/licences.

It is important to note that the legislative scheme contains only the minimum or the basic provisions which a law must contain to provide a sound legislative basis for regulating drugs or medicinal products. In adapting this Law to suit individual needs and circumstances additional provisions may have to be included. The provisions of the legislative scheme will be in addition to those already contained in other legislation dealing with health practitioners, such as medical practitioners and pharmacists, although a chapter on the latter is included.

Due to constitutional or administrative law principles, the laws and regulations of some countries do not necessarily apply to the State or public sector, unless there is specific provision to the contrary. Even if they do apply, sometimes they are not strictly followed to the same extent as by the private sector or the general public. This legislative scheme provides for the State or the public sector to be bound to the same extent as the private sector or the general public. There is no scientific basis to exempt from regulatory and control regimes medicinal products procured or manufactured by or on behalf of the State or the public sector.

POTENTIAL VALUE OF THE SCHEME

The scheme on which the legislative scheme is structured is of particular value to small national drug regulatory authorities with limited manpower and other resources for a number of reasons:

1. The scheme envisages the compilation of an inventory of medicinal products on the market, by placing the burden of providing the necessary information on importers, manufacturers and exporters. After the appointed date, a medicinal product in respect of which the necessary documentation had not been submitted may not be imported, manufactured or exported without the written permission of the Drug Regulatory Authority or the Board, thus facilitating supervision over the movement of medicinal products on the market.

2. The inventory can be compiled by using a small desk-top computer with a software programme tailor made for the purpose.

3. After the appointed date, the Drug Regulatory Authority or the Board can decide on the type of regulatory action to be taken in respect of any individual medicinal product or group of medicinal products by having regard to the country’s national drug policy and the health care needs and the nature of regulatory action to which the product is subjected to in other countries that have comprehensive systems in place for the assessment and regulation of medicinal products. The scheme provides for a system of ‘provisional authorization/registration’ in respect of medicinal products for which information was provided on or before the appointed date, and for a system of product licensing for medicinal products sought to be imported, manufactured or exported after the appointed date. Provisionally authorized/registered medicinal products qualify for product licences/marketing authorizations, after evaluation or such products may have to be withdrawn from the market if a decision to this effect is made by the Drug Regulatory Authority or the Board. The process for such evaluation has to be phased in as small national drug regulatory authorities without trained manpower and adequately equipped laboratories will find it difficult to undertake the assessment and registration of drugs, similar to procedures followed in countries where regulatory systems had evolved over many decades and which are able to rely on qualified manpower for the assessment of medicinal products.

4. The scheme has the flexibility to permit provisionally authorized/registered medicinal products to remain on the market until such time that a decision is taken to prohibit or otherwise regulate them, thus preventing any sudden or artificial shortages. This approach has the advantage over those which do not permit any medicinal products to be marketed unless authorized, registered or licensed; constraints of manpower for assessment and authorization will not permit the speedy assessment of medicinal products. Under the scheme the market will be gradually regulated through a process of assessment leading to product registration or withdrawal of the provisionally registered status. As described in section 2.2 of the Guiding Principles for Small National Drug Regulatory Authorities (2) entitled “Screening of provisionally registered products”, there must be a rapid initial screening process to secure the withdrawal of products which simply on the basis of a review of their ingredients and indications are judged not to meet admissible standards of safety, quality and efficacy. This must be followed by the phased-in definitive assessment of all provisionally authorized/registered products on the basis of priorities. Applications for products which are to be imported, manufactured or exported for the first time after the appointed date will be assessed simultaneously.

5. In addition to screening individual medicinal products, or groups of medicinal products, the legislative scheme provides for regulatory action of a general nature. Through regulations or orders provision can be made for compliance with good manufacturing standards; the use of the WHO Certification Scheme on the Quality of Pharmaceuticals Moving in International Commerce; compliance with international nonproprietary names, labelling and advertising requirements etc.