11th International Conference of Drug Regulatory Authorities

keynote address

Madrid, Spain
16 February 2004

Señora Pastor, colleagues, ladies and gentlemen,

It is a pleasure to be with you today for this important meeting. You, and your colleagues in the drug regulatory authorities around the world, play a vitally important part in ensuring the safety, quality and efficacy of medicines, blood products, vaccines and biologicals.

The greatest achievements in our time have involved wide and effective coverage with immunization and treatment. They would not have been possible without your effort, and the world will need that effort even more for the work that lies ahead.

The increase in volume and complexity of trade in pharmaceutical products continues to accelerate. Not only the products but the starting and intermediate materials used for making them are all traded internationally. The finished products in their turn may be repackaged and re-traded several times before they reach their end users. Speed can make the difference between success and failure, both in trade and in medicine, so there is pressure to make regulatory procedures quick and minimal.

Especially where there are demands for medicines on a large scale, at short notice, to fight an epidemic or support a campaign, manufacturers can also find themselves under intense pressure to skip some of the mechanisms designed to ensure safety and quality.

In addition, patients and their carers are increasingly turning to the Internet for alternative treatments, lifestyle drugs and cheaper medicines. This exposes them to products that may not have been subjected to any regulatory control.

All these trends combine to help substandard or counterfeit medicines circulate more and more easily, presenting a growing threat to public health. Regulatory authorities increasingly find themselves in difficult situations, with strong but conflicting demands coming from government, business and the public.

All the stakeholders need to make a full review of this situation and find new ways to tackle it. Your discussions here this week can make a valuable contribution to this process.

An initial step towards making drug regulation manageable internationally is to enable more countries to have their own effective authorities. At present, only half of them do, and almost a third of the countries in the world have no regulatory system at all. It is the countries most in need of safe and affordable medicines that lack this regulatory facility.

The gap can be bridged in part by making all existing regulatory information publicly available and easily accessible. This can save time and avoid duplication of effort for other regulators, prescribers, pharmacists, health workers and consumer groups.

Especially where medicines are being used to fight diseases that are killing thousands, regulatory activities have to be made as simple as possible. In many cases, assessments made in other countries can be valid where there is harmonization of regulatory requirements. Harmonization can facilitate access and lower prices, and is developing rapidly in some parts of the world. But, harmonization lags far behind for multi-source generic drugs and these include most of the affordable essential medicines.

In all countries, adverse drug reactions are a major concern. They are the fifth leading cause of death in the USA, and elsewhere up to 17% of the health care budget is spent on dealing with them. A good pharmacovigilance system costs only about one dollar for every thousand spent on the purchase of medicines.

The challenges include preventing the adverse reactions that can be caused by unsafe herbal medicines, ensuring the safety of products derived from blood and plasma and making an ever-expanding array of vaccines available to those who need them. Regulation, in these and other areas you will be discussing, requires the development of special expertise.

International negotiations, though slow and unpredictable, can present new opportunities to make safe and effective drugs more accessible. The World Trade Organization's decision last August, on Paragraph 6 of the Doha Declaration on TRIPS and Public Health, has the potential to facilitate the export of affordable medicines to the countries that need them most. Much depends on how this decision is implemented in countries without their own pharmaceutical production facilities. They need all the support we can give them, both through WHO and through your own organizations.

A catalyst and focus for many of the activities needed in this field is our current campaign to get three million people in developing countries onto antiretroviral treatment by the end of 2005. To assist countries in obtaining the products they need for this, we have established an AIDS Medicines and Diagnostics Service. It builds on work carried out over a number of years by WHO, UNAIDS, UNICEF, the World Bank and the Global Fund, to bridge the treatment gap in developing countries. The AMDS is based at WHO in Geneva and is run jointly with our UN partners.

This service will provide buyers with up-to-date information on the sources, prices and regulatory status of antiretrovirals. It will continue to purchase diagnostic tests as part of its bulk procurement scheme and will be keeping manufacturers informed of anticipated needs. It will also be working with you and your colleagues to support product specification and registration, prequalification of antiretrovirals and diagnostics, and quality assurance for local production.

The same partnership also provides a mechanism to ensure safety, efficacy and quality through the prequalification of products for HIV, malaria and tuberculosis control. It has helped to make nearly 100 reliable products available worldwide to date. Thanks to the support and expertise of many regulatory authorities around the world, this has become a highly effective and technically robust service.

During the twentieth century, technical innovation made an enormous contribution to improving health status. Progress has continued for some tropical diseases such as African trypanosomiasis and visceral leishmaniasis, but for malaria and tuberculosis innovation fallen well behind current needs. The older drugs are failing either because they encounter resistance or because they do not meet present-day standards of safety. In many countries, even where there are potential new products, regulators do not have the capacity to assess their safety and efficacy.

Slow progress in developing malaria and tuberculosis medicines is a major problem area, and one that will benefit from your particular attention during this week. Recently, the European Medicines Evaluation Agency has been authorized to advise on products for use outside Europe. This is but one example of how regulators globally can help the countries most in need.

To establish new drug regulatory authorities and strengthen those that are not yet working properly will require more of this kind of solidarity, as well as innovative thinking and a realistic investment. Your discussions during the next three days provide a valuable opportunity for sharing ideas and information on what works.

To sum up, it is in the interests of everyone to have reliable national and international drug regulatory systems. The health authorities, the health workers and the public cannot do without this assurance, nor can the pharmaceutical companies.

Your work can rightfully claim the wholehearted support of all concerned. You certainly have that of WHO and I wish you every success in your discussions here this week.

Thank you.