The difficulties to Access Quality Medicines in Africa

The reality of HIV patients dying without having seen a doctor, the great number of medicines sold in the markets, the decreasing quality of public health and the increase of traditional medicine are some of the consequences of a deeper problem, the lack of access to quality medicines for all inAfrica.

 

Despite the efforts done by national and international institutions, most patients in Africastill face difficulties to access quality medicines. We will look only at neglected diseases with a main incidence inAfrican countries e.g. malaria, TB, HIV, lashmaniasis, sleeping sickness, etc.

 

In the last decade the international environment related to medicines has gone through significant changes. New barriers have appeared with fatal consequences for individual and public health inAfrica, but there have been also new initiatives and successes. We will look at the different aspects that impact on the Access to Quality Medicines inAfrica; Research and Development (R&D); quality of medicines; appropriate delivery; cost of medicines and financial access; and lack of financial accessibility.

 

Research and Development of medicines

 

Research and Development of medicines is linked to intellectual property. Patents grant a monopoly on the production and sale of the invention, as a way to recover the cost of research. This means that the enterprise that produces a new medicine has 20 years of monopoly where it decides on the price and the countries where this medicine will be sold. The pharma industry prefers to invest in rich countries where the market and profits are big, while it neglects the needs of people in poor countries, because of the small market with minimum profits. *Of a total of 1.556 new medicines only 18 (1.3%) are dedicated to tropical diseases, while there are 55 millions persons at risk of suffering from sleeping sickness, and 350 millions from lashmaniasis. A new approach is needed, open to innovative initiatives. Charitable foundations, NGOs, among themAEFJNhave done a big effort through field programs and advocacy. Specific research private-public partnerships programs have been developed with different stakeholders, though still most of the funding comes from philanthropic organizations. Governments have a responsibility to ensure funds in proportion to their Gross Domestic Product (GDP). Research programs should ensure that the product outcome of the research is actually delivered to the target population. The report of the World Health Organization (WHO) on these issues urged the states to secure sustainable funding for developing and making accessible products to address diseases that affect mainly developing countries.

 

Quality of medicines

 

In each country there is an authority that guarantees that medicines are effective, safe and of appropriate quality. Unfortunately in mostAfrican countries, due to the lack of resources, these centres exert poor control on the quality of the medicines manufactured, imported and distributed in the country. Some international institutions have programs to supportAfrican governments in their choice of medicines. In 2002 the WHO started a pre-qualification project to asses the quality of AIDS, TB and malaria medicines. They publish the list of manufacturing sites and of products that have been approved. This initiative has introduced a regulation showing that international standards are applicable forAfricaand warning producers that quality verification must be a pre-requisite for purchase. Clinton and Gates foundations and Global Fund also make the list of products approved for supply. The European regulatory authority (EMEA) gives scientific advice on products developed for use outside the EU. All these initiatives are specific for three diseases (HIV, malaria and tuberculosis) and do not cover the essential medicines list of the WHO. The lack of resources of mostAfrican countries prevents them to thoroughly assess pharmaceutical manufacturing sites, products and distribution channels.

 

In some countries there is a strong control for medicines sold to western countries, while the medicines destined exclusively for export to poor countries do not follow the same practice. It is the country receiving the medicine that is responsible for the quality control. How canAfrican countries that have not enough resources do this control? The losers are the patients who have no guarantee of the quality and efficacy of the medicine bought even in pharmacies. The lobby of NGOs is pushing some countries to control the medicines for export.Belgiumhas a new legislation to control quality of drugs manufactured for export.Francehas a legal procedure allowing for “public health reasons” to refuse the export of non-authorised medicines.

 

Linked to the quality of medicines is the lack of visibility on the consequences of not-good-enough medicines for the health of the people. This is the reason why even donors and health staff underestimate this aspect.

 

InAfricaover the last years there has been a growing awareness of the problem of fake medicines.  Distributed through the black market these medicines with few or none active product mislead consumers about the identity or origin of the drug. To solve this plague we need not only to fight the “street medicines”, but even more to work at bettering the access to medicines.

 

 

Appropriate delivery in a globalized market

 

The globalization of the pharmaceutical sector has led to open international markets and lack international rules. New drugs, active ingredients and essential medicines are now produced and sold all over the world. The many distribution steps make it difficult to asses the “origin” of the medicine. All producers and distributors do not apply the standard regulations. As a result patients in poor countries are treated with medicines that are not sufficiently active or that cause prejudice to their health and which undermines the healthcare system.

 

Often inAfrican the centres that have to verify and enforce quality have a low budget and limited resources, and there is no guarantee that medicines will comply with appropriate standards.  The strong pressure on getting the lowest prizes, rather than the quality requirements, pushes some suppliers to reduce costs of raw materials, maintenance and quality assurance. Some donors unaware of the risks related to lack of quality, do not take into account quality requirements and medicines of unverified quality may reach the patients. A global solution should be a coordinated action of all the stakeholders: WHO, manufactures, distributors, control quality centres, governments, donors, etc. to establish international standards before the medicines reach the poor countries.

 

Cost of medicines and financial access

 

The TRIPS agreement of the World Trade Organization played a determinant role in the access to new medicines inAfrica. The monopoly of the patent delays the introduction of generics (cheaper medicines that contain the active ingredient of the medicine), keeping the prices high and preventing access to new medicines. The best example is the life-saving antiretroviral (ARV) therapies, which cost a decade ago was $10,000 to $15,000 a year, beyond the means of mostAfrican countries where the need was greatest, but thanks to an international outcry led to a court challenge, the price of Aids drugs resulted in being slashed to $150 a year in July 2006 and has even decreased later on. The voluntary pricing policies put in place by the pharma companies played a role in the initial phases, though insufficient. It was only when producer countries used the “compulsory license” to produce generics that the real breaking through of prices took place.

 

While in 1990 only 5% of pharmaceutical products were generics, today with the explosion ofIndiaandChinain the medicine market the generics are very numerous. Before, 90% of the active material was produced in Europe andUSA, today 80% of these materials come fromIndiaandChina. Most generics come also from these countries, some of which are of very good quality (but not all).

 

The DOHA Declaration encourages countries to use the “flexibilities” of TRIPS, especially compulsory licenses, to lessen the negative impact of patent protection. But in real life countries with manufacturing capacity find many difficulties to use these rights. WhenThailandissued 3 compulsory licenses the patent holder, Abbot, withdrew all its new medicines from the registration process in the country. Both the EU and theUSAofficially questioned the use of this flexibility by the Thai authorities. In 2006 Novartis challenged the right of the Indian Government to issue a “compulsory license” and took it to court. In August 2007 the Madras High Court ruled that the government had not violated the Indian Constitution, and was able to balance the commercial interests versus the right to health.

 

Lack of financial accessibility

 

As a consequence of the structural Adjustment Programs of the 80’s and the strict budgetary control imposed on the public healthcare, user fees were imposed. The cost for patients affected seriously individuals and the public health system. Patients not able to afford these charges will turn to the informal sector or lack care all together. This creates a place for the black market of counterfeit medicines and illegal health care.  Added to the fees the patient has to add transport, food, and other expenses. Access to healthcare is a social right for all. But the lack of access will be a break to the fulfillment of the Millennium Goals in Health. It is of great importance to find sources of sustainable funding.[1]

 

This article is based on “Access to Quality Medicines in Resource-Poor Countries” by Raffaella Ravinetto IMT Antwerp, Belgium