The Pharmaceutical Journal
Vol 269 No 7215 p372-373
14 September 2002

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World Congress of Pharmacy and Pharmaceutical Sciences summary

Ways of improving access to essential medicines in developing countries

One third of the world's population lacks access to essential medicines. In the poorest parts of Africa and Asia, this figure rises to one half. Ninety-five per cent of tuberculosis cases and 98 per cent of TB deaths occur in poor countries. World-wide, 79 per cent of people with TB do not have access to treatment. There are 300 to 500 million new cases of malaria each year, of which one to two million result in death. Ninety-five per cent of the 36 million people with HIV/AIDS live in developing countries. Research and development into diseases that affect the poor has stagnated because of the lack of economic incentives. The last major new TB drug was developed 30 years ago. Resistance to all infectious disease treatments is on the rise.

Many developing countries have pharmacy regulatory systems staffed with well-trained individuals that are unable to operate due to lack of resources, corruption or ineffective laws. Some countries are unable to stop the flow of counterfeit drugs despite possessing the appropriate technical knowledge and equipment to do so and others do not have the resources to test new drugs that come on to the market to ensure their quality. In many instances, countries do not have the drug management infrastructure and resources effectively and efficiently to procure, process and distribute medicines. Where systems do exist to ensure delivery of medicines, the lack of resources often limits the extent to which patients can afford treatment.

It was against that background that the Pharmacy Information Section of FIP and the World Health Organization jointly presented a symposium on 5 September entitled "Access and equity: the challenge of getting medicines to the people who need them".

Opening the symposium, David Lee, Centre for Pharmaceutical Management, Management Sciences for Health, Panama and United States, told the congress that access to medicines is a multidimensional concept. Dimensions of access include the medicine's geographic accessibility, availability, affordability and acceptability.

Mr Lee explained these terms. Geographic accessibility refers to the relationship between the location of the product or service and the location of the eventual user. Availability is the relationship between the type of product or service needed and the type and quantity of the product or service provided locally. Affordability is the relationship between the price of the product or service and the user's ability to pay for it. And acceptability is the fit between the user's attitudes and expectations about the product or service and its actual characteristics.

Improving access to medicines means increasing all four of these factors. "But if the quality or effectiveness of the medicines is low," said Mr Lee, "then all this is meaningless."

The second speaker outlined the World Health Organization's Essential Drugs Programme. Hans Hogerzeil, base at the WHO in Switzerland, said that the EDP, which is now in its 25th year, could point to several achievements relating to improved access to and use of essential medicines:

• National drug policies are being introduced at a growing pace in every region of the world

• The essential drugs concept is nearly universal

• Treatment guidelines and formulary manuals have put the essential drugs concept into clinical practice

• Training in rational prescribing has expanded in universities throughout the world

• The number of people with access to essential drugs has nearly doubled in the past 20 years

Elaborating on that last point, Mr Hogerzeil pointed out that at the same time, the world's population has increased and the actual number of people with no access to essential drugs has remained the same. "This shows that the poor have remained poor," he said.

However, at the same time, much remains to be done. Substandard drugs are common. (For example, analysis has shown that some 60 per cent of drugs available in developing countries have no active ingredient at all.) Irrational drug use remains a widespread hazard to health. He said that half of all countries have no regulation of drug promotion. Half of 15 billion injections given in developing countries are not sterile. Finally up to 75 per cent of antibiotic use is inappropriate and this is a huge problem for resistance in the long run — and that was in teaching hospitals. Finance, delivery and other constraints still limited access to essential drugs.

"These concerns, coupled with the fact that new essential medicines are expensive, reinforce the importance of ongoing and concerted actions being taken in relation to enhancing access to and use of pharmaceuticals," said Mr Hogerzeil.

As an example he mentioned that the cheapest antiretroviral treatment cost $300 to $600 per patient per year. But 38 countries have a drug budget of less than $2 per person per year. "This is a huge problem for AIDS treatment," he said. Another example was that Malarone treatment for malaria was some 400 times more expensive than chloroquine.

He went on to outline some promising developments:

• An access framework has been identified and work continues on the development of reliable indicators for measuring access

• The increased availability of price information promotes transparency and competition

• Advocacy, corporate responsiveness and competition have reduced the price of antiretroviral drugs by 95 per cent in three years

• There is an increased number of drug financing options with an increasing number of countries having some form of drug benefits as part of health insurance

• There are a number of successful experiences with local supply systems and regional bulk buying

"The essential drugs concept is more valid than ever, and the unfinished agenda is large," Mr Hogerzeil concluded.

Rafaella Ravinetto (Médecins Sans Frontières Campaign for Essential Medicines, Switzerland) discussed the impact of patents and prices on access to treatment in developing countries. She said that, currently, about one third of the world's population lacks access to essential medicines. One of the major reasons for this is their high prices, which are often related to patents. For instance, gross national income in Burkino Faso is about $210 per person per year and antiretroviral treatment costs much more than that.

Another major reason is that few new drugs are being developed to tackle the diseases of developing countries and some existing and new drugs are simply too expensive.

Ms Ravinetto pointed out that of nearly 1,400 new chemical entities examined between 1975 and 1999, only 16 were for tropical disease. Five of these had been discovered through veterinary research and four through United States army research. One was a traditional Chinese medicine and two were reformulations of older medicines.

Equity pricing

Ms Ravinetto believed that financial considerations should not limit appropriate use of essential drugs and suggested that a solution may be equity pricing.

"Equity pricing is the policy of dramatically reducing drugs prices so that the become truly affordable to people in need," she explained, adding that it can be achieved through a combination of strategies:

• Agreeing on a clear and standardised international guideline for differential prices offered by companies to developing countries

• Increasing competition on the world pharmaceuticals market by including generic products

• Raising awareness of TRIPS (Trade Related Aspects of Intellectual Property Rights, see also www.wto.org) safeguards and ensuring their full implementation according to the principles of the Doha Declaration (which, in November 2001, reasserted the primacy of public health interest over market-driven interests)

• Implementing a global or regional procurement and distribution system to support countries in need of external technical support

• Encouraging and strengthening local production by means of licensing agreements and technology transfer

Equitable access to medicines can be achieved, Ms Ravinetto declared, but political willingness is needed to put lives before profit.

The subject of drug donations was raised by Serge Barbereau, Réseau Médicaments et Développement (ReMeD), France. Could donations contribute to improved access? He said that reports have shown that the role of drug donations in this regard is not positive. In many instances the donation of medicine has become reflex, with the media often defining the need and creating an atmosphere that contributes to making people in developed countries feel guilty. "Although this is not necessarily bad, since there is a need to increase awareness about problems relating to lack of access, there is a danger that this approach will result in donations that are made quickly, without much thought, and based on what is available for donation — or surplus to requirements — as opposed to what is really needed," he said.

He outlined some of the many problems with drug donations:

• Provision of outdated medicines or providing excessive amounts of a medicine that will become outdated before it can be used

• Provision of drug samples

• Provision of medicines not matching a country's needs or not on the WHO's or a country's essential drugs list

• Donation of drugs to countries or institutions that do not have adequate storage or distribution capacities

• Inappropriate valuation of the donation — often the value is defined by the donor country and not by the recipient country

Another problem is that, just like all donations, the donation of drugs creates a dependence of the recipient on the donor.

Mr Barbereau concluded by saying that it is necessary to educate health care professionals and the general public about donation programmes, and to enhance these by basing them on appropriate pharmaceutical needs evaluation, awareness of essential medicines, advice of pharmacists and appropriate pharmaceutical care principles.

Professional and political issue

The final speaker was John Bell, president of the Commonwealth Pharmaceutical Association. Mr Bell, who is a community pharmacist in Australia, said that the issue of access to medicines has become a highly significant issue both professionally and politically, having been for some time a major topic of discussion within WHO and at other non-government forums. He believed that the profession of pharmacy is ignoring the fact that many of the impediments to access are technical barriers which have already been overcome in developed countries. These barriers included counterfeit medicines, ineffective distribution systems, non-existent or corrupt regulatory procedures, absence of rational drug use strategies and a lack of pharmacovigilance. "National pharmacy organisations and individual pharmacists have an important role in identifying and helping to break down these access barriers," he said.

Major impediments to progress are that there are too few pharmacists in developing countries who are inadequately train ed and who are insufficiently recognised by their governments, non-governmental organisations and other health providers.

Mr Bell suggested solutions to these problems. He said there should be proper workforce planning and better working conditions by way of remuneration and provision of ongoing continuing professional development, which currently is often not available.

Recognition could be increased by establishing collaborative projects and activities involving local pharmaceutical societies, the government and the industry and by gaining representation on government committees. The training issue could be helped by assisting poor countries to develop their pharmacy undergraduate curricula so that pharmacists would have the skills to manage drug supply. The provision of distance learning courses would also be helpful.

Both FIP and the CAP have a role to play in this, Mr Bell said. They could assist with education and training, foster young pharmacists and help to strengthen local pharmacy organisations. "Collaboration with developing countries is crucial," he concluded.