Strengthening the Biological Weapons Convention
Briefing Paper No 8: Article X : Pharmaceutical Building Blocks
Executive Summary
Series Editors, Graham S. Pearson and Malcolm R. Dando
Department of Peace Studies, University of Bradford
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Attention is being given by the Ad Hoc Group (AHG) to measures to implement Article X of the Convention in accordance with its mandate. As progress is being made on the development of the rolling text for the Protocol to strengthen the Convention, it is timely to consider how the implementation of Article X might contribute to the strengthening of the effectiveness of the Convention. Briefing Paper No 6 considered some of the developments that have occurred nationally, regionally and internationally in respect of the use of bacteriological (biological) agents and toxins for peaceful purposes. It noted that there is increasing awareness world-wide because of public health and environmental concerns of the need to control the handling, use, storage and transfer of such biological agents. That Paper examined some of the current controls and regulations for biological agents and the international initiatives that are ongoing to strengthen biosafety around the world. Briefing Paper 7 considered the national regulations in the UK, the EEC and in the United States as well as some other countries in respect of micro-organisms and biosafety with the aim of providing some further building blocks to be considered in the strengthening of the BTWC and the implementation of Article X of the Convention. These were seen as building blocks which might be considered from a point of view of strengthening the BTWC as well as contributing to the implementation of Article X.
This Briefing Paper addresses pharmaceutical building blocks. It outlines national regulatory systems, using that of the UK as an example, and how this has developed into a regional European Union (EU) regulatory system. Various international harmonization initiatives are addressed, ranging from the International Conference on Harmonization (ICH) which seeks to harmonise the data requirements for product licences between the EU, Japan and the US, Mutual Recognition Agreements (MRAs) being developed between the EU and several other countries, the Pharmaceutical Inspection Convention (PIC) and the PIC/Scheme, to the WHO Certification Scheme. There are common elements between these schemes, notably in respect of the Good Manufacturing Practice guidelines being adopted in many countries. The contribution that can be made to the strengthening of the BTWC through the promotion of such standards internationally is considered.
NATIONAL AND REGIONAL REGULATORY SCHEMES
The controls which apply to the manufacture and supply of medicinal products -- for humans or animals -- within the United Kingdom are outlined. These have been subsumed into the EC regulations which apply to all Member States of the EC. It is evident that there are specified standards, including requirements for Good Manufacturing Practice that apply throughout the European Community for the manufacture of human and veterinary medicinal products. Any such products that are to be marketed require both a marketing authorization (or product licence) and a manufacturing authorization (or manufacturer's licence). Compliance with both of these is monitored by repeated inspections by the appropriate inspectorate.
INTERNATIONAL REGULATORY SCHEMES
As might be expected, following the regional harmonization of regulatory controls such as that achieved within the European Community, attention has been directed to wider harmonization. There are basically two strands: one relating to the harmonization of data requirements for product licences or for manufacturing licences, and the other relating to the international acceptance of inspections and inspection reports. In essence, there are four principal initiatives which have progressed to some extent in parallel. These are:
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a. The Pharmaceutical Inspection Convention (PIC) which was signed in 1970 and sought to enable regulatory authorities in one country to accept the results of inspections carried out by another regulatory authority in the other country. Its provisions, however, were incompatible with the legal requirements of the European Community. Consequently, the Pharmaceutical Inspection Convention in 1995 developed into the Pharmaceutical Inspection Co-operation Scheme (PIC/S) which avoided the clash with the European Community requirements. A related scheme is that for the Mutual Recognition of Evaluation Reports on Pharmaceutical Products (PER Scheme).
b. The International Conference on Harmonisation (ICH) of technical requirements for registration of pharmaceuticals for human use. This brings together the regulatory authorities of Europe, Japan and the US and representatives from the pharmaceutical industry association representatives in the three regions to address how harmonisation of technical guidelines and requirements for product registration might be achieved. Many such technical guidelines and requirements have now been agreed.
c. Mutual Recognition Agreements (MRAs) which are being developed between countries and between the European Community and other countries. These are aimed at recognizing that conformity with the regulatory standards in one country is acceptable in the other country. They are thus equivalence agreements.
d. The World Health Organization (WHO) Certification Scheme on the quality of pharmaceutical products moving in international commerce. In this, at the request of a commercially interested party, a Member State will attest to the competent authority of another Member State that a specific product is authorized to be placed on the market within its jurisdiction, that the plant in which it is produced is subject to regular inspections to establish that the manufacturer conforms to GMP as recommended to the WHO and that all submitted product information is currently authorized in the certifying country.
CONCLUSIONS
It is clear that in pharmaceutical and biotechnological production facilities engaged in manufacturing licensed products, these facilities will increasingly be inspected at regular intervals by national regulatory authorities to monitor their compliance with internationally harmonised standards for GMP in order for these facilities to be licensed. Insofar as the Protocol being negotiated by the Ad Hoc Group is concerned, the information as to whether a production facility is licensed to GMP standards should be part of the information to be provided in declarations of such facilities. This information, together with the GMP standard to which it has been inspected, and the date of the last such inspection by the national regulatory authority will help to build confidence that the facility is compliant and is engaged in permitted purposes.
It follows that measures to assist developing countries establish a national regulatory system of product and manufacturers' licences to internationally agreed standards would both directly implement Article X of the BTWC and also contribute to building confidence in compliance with the Convention. Such measures would also be in accord with the actions being taken by developed countries following the Rio Summit of 1992 and the emphasis on aiding capacity building in developing countries.
These building blocks together with those addressed in Briefing Papers No 6 and No 7 are all measures that improve national, regional and international standards of health and safety so bringing clear public health and environmental safety benefits to all States. They also help to ensure that microorganisms and toxins are not misused for prohibited purposes and hence directly contribute to building increased transparency and enhanced confidence that the States concerned are in compliance with the Convention thus providing both national and international security benefits.
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The Biological and Toxin Weapons Convention Database forms part of the Project on Strengthening the Biological and Toxin Weapons Convention and Preventing Biological Warfare, which is based in the Department of Peace Studies, University of Bradford, UK.
Updated 21 August 98.