Improving equity of access to medicines. (Pharmaceuticals).

The issue of access to medicines by developing countries around the world is one of great significance. Good health is vital for the economic development of nations, and promoting the health of their citizens is one of the most important duties of Governments. As the use of pharmaceutical products can be very effective and a practical means of promoting health, it is not surprising that access to medicines is a hotly debated and politically charged topic. It is therefore important to understand the real factors that affect such access and consider how best to facilitate it for the benefit of populations worldwide. In particular, the question of access to quality medicines for resource-poor countries is especially important as they are most affected by major diseases, such as HIV/AIDS, tuberculosis and malaria, which particularly affect developing countries. An effective response to the special needs of these countries requires broad-based partnerships of actors from all sectors.

The global research-based pharmaceutical industry, which the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) represents, fully supports efforts to improve real access to essential drugs for developing countries, especially the poorest. In fact, this industry has contributed circa $2 billion in products since 1998 to healthcare efforts in developing countries, which is significantly more than the contributions of several industrialized countries. Indeed, company access initiatives and partnerships have saved the lives and health of literally tens of millions of people around the world.

For example, Merck's MECTIZAN(R) programme has saved over 30 million people from river blindness since 1987. Aventis Pasteur's donations of 50 million doses of polio vaccine have been key to the global effort to eliminate polio in the world--a goal which is now within reach--thanks to partners such as Rotary International, the World Health Organization (WHO) and others. In the fight against the global AIDS pandemic, the Accelerating Access Initiative (AAI) for AIDS drugs has significantly increased the number of patients receiving antiretroviral treatment in Africa--the continent hardest hit by the pandemic. AAI has been a pioneering effort to harness the resources and expertise of the public and private sectors to effectively respond to the broad challenges of AIDS. It is a joint initiative of six pharmaceutical companies--Abbott Laboratories, Boehringer-Ingelheim, Bristol-Myers-Squibb, GlaxoSmithKline, Merck & Co. Ltd., F. Hoffmann-La Roche--and five UN agencies--joint UN Programme on HIV/AIDS, WHO, UNICEF, UN Population Fund and the World Bank.

The Initiative is active in over twenty countries and about eighty more are in discussion with the United Nations to become part of this Initiative.

Boehringer-Ingelheim is providing its antiretroviral product, VIRAMUNE(R), free of charge to Governments in developing countries for their programmes designed to prevent the mother-to-child transmission of HIV. Other major international companies are offering their AIDS products at cost, below cost or even free of charge in those countries.

These efforts have been particularly helpful for poor developing countries and have had an important effect on improving equity of access for their populations. Details about these partnership programmes and many more are available at the IFPMA web site (http://www.ifpma.org).

While these initiatives have improved access to needed medicines, they have also shown the real barriers to be overcome to improve and promote equity of access among and within countries. In particular, there is a dramatic need to increase health-care funding and infrastructure development in many developing countries. Indeed, experience has shown that even freely donated pharmaceuticals cannot reach intended recipients if the infrastructure is not there to handle them. Thus, three key priorities must be set:

Additional funding for low-income developing countries. Resource-poor countries, some of which have a per capita income of less than $1 per day, face particularly difficult challenges in providing quality health care for their populations. Even free medicines require safe transport, administration and monitoring to be used effectively, the costs of which can be beyond the means of some public health authorities. Thus, it is very important that international and bilateral donors increase their support to poor countries for improving their healthcare systems. Experts in the field have estimated that over $10 billion annually is needed in additional resources to fight AIDS alone. In addition, the new Global Fund for AIDS, Tuberculosis and Malaria could become an important facilitator in building up the national health-care capacities of poor countries if used effectively and run efficiently. Partnership efforts which aim at improving access for the poorest countries will play a major role in improving equity of access among countries.

Higher prioritization of health care nationally. Government commitment to improving health care is a vital component in any attempts to expand access to medicines and improve the equity of access within countries. However, populations, even within mid-income developing countries, are not receiving necessary medicines, often due to disproportionate access to health-care facilities; rural populations may suffer if hospitals and clinics are concentrated in urban centres, for example.

In some countries, governments do not put health-care spending as a high enough priority in their budgets or expenditures. For example, commentators in South Africa have noted that the Government paid billions of dollars for new high-tech submarines, warships and fighter aircraft in 2000 when, in the Archbishop of Capetown's phrase, "... the question has always been whether so much should be spent on arming ourselves for some future possible threat when there is so much internal threat now present". But antiretroviral treatment was (and still is) widely inaccessible, despite company offers of their products at favourable terms.

Commitment to pharmaceutical quality and effective and appropriate use of medicines. When one speaks of "access to medicines", it must be clear that what is meant is access to quality medicines which meet international standards of safety, efficacy and quality. The international research-based pharmaceutical industry is firmly committed to ensuring that all their medicines meet the high standards needed to ensure patient safety--our companies do not believe in "poor drugs for poor people" or double standards. Furthermore, the multinational companies provide market monitoring to catch possible adverse reactions. Finally, they commit significant resources to educating health-care professionals regarding the benefits and appropriate use of their medicines. All of these efforts lead towards improving the quality of health care worldwide and help ensure that poor people also will have access to quality medicines.

Efforts to improve access and equity will thus need the firm commitment and resources/expertise of a variety of partners: international agencies, bilateral and multilateral donors, national authorities, private-sector enterprises, including pharmaceutical companies, and responsible non-governmental organizations. One potential set of partners, however, has not been very visible in the current access debate--generic pharmaceutical manufacturers. While much of the public debate over access and equity of access has focused on newer patented medicines, most of the problem actually concerns non-patented medicines. In fact, over 95 per cent of the medicines on the WHO Model Essential Drugs List--the basic list of drugs which are considered important for the majority of the population in developing countries--are off-patent worldwide. Also, drugs that may be patented in industrialized countries may not be in many low-income or least-developed countries due to individual company decisions not to patent in those count ries in light of individual market considerations or company policy.

For example, Professor Amir Attaran of Harvard University clearly showed in a landmark article ["Do Patents for Antiretroviral Drugs Constrain Access to AIDS Treatment in Africa?", Journal of the American Medical Association, Vol. 286, No.15, 17 October 20011 that antiretrovirals were not patented in many sub-Saharan African countries. Yet, access to unpatented essential drugs is lacking in many poor countries and among poor populations. In India, for example, even though there are no product patents on pharmaceuticals and over 22,000 local manufacturers, access to essential medicines is sorely lacking for large populations within the country. This deficiency is further proof of the importance of overcoming these barriers. However, if one wishes to further promote the "equity" of access, generic producers could play a major role in producing generic copies of unpatented drugs in poor countries or even transferring technology to low-income countries to promote the growth of a quality generics industry to manuf acture such non-patented products.

Finally, a key and often overlooked aspect of equity in access to pharmaceuticals concerns innovation for new medicines. Improved and innovative products that can provide new cures and treatments for diseases are extremely important for public health. Furthermore, easier-to-administer drugs or more efficient treatment regimes can make it easier for public health authorities to reach out to wider populations. However, this requires strong intellectual property rights such as patents, as it would provide the necessary incentives and protection that are vital for continued innovation. By stimulating new research and significant improvements in medicines, intellectual property rights provide greater equity of access by supplying more medicines and a better portfolio of medicines to meet public health needs.

In conclusion, equity of access to medicines is a complex issue requiring many partners to work together to improve access for poor populations in the developing world and in poor countries, and the global research-based pharmaceutical industry is committed to continuing its efforts in this regard. It is also important to focus on the real barriers to improving access and resolving inequities of access. We look forward to continuing, in partnership with international organizations, national governments and responsible members of civil society, to help bring the benefits of pharmaceuticals to needy populations around the world.

Eric Noehrenberg is Director of the International Trade and Market Issues at IFPMA. He also worked at UNAIDS, where he facilitated partnerships with the private sector and conducted negotiations, and has authored many articles on intellectual property and health issues.