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An End to Falsified Medicines

Posted by Dr. Aboubakrine Sarr on 13 October 2010

Medicines are an important factor in the management of the health of populations. The prescription and rational use of medicines ensure for patients a therapeutic outcome based primarily on the quality, effectiveness, and safety of the drugs themselves. In sum, results hinge on proper practices in terms of manufacturing, distribution, and dispensing. The effectiveness of medication depends on its traceability.

Nowadays, it is a truism to recognize the importance of counterfeit drugs commonly called falsified medicines. They represent roughly 10% of the world market; adding up to nearly 45 billion US dollars within a global pharmaceutical production that totals approximately 570 to 575 billion US Dollars. Predictions for 2020 foresee world production reaching a value of 1,200 to 1,300 billion US dollars. The tragic health, social, and economic consequences will certainly be considerable if we are not careful.

According to WHO, if counterfeit drugs in certain developed countries represent about 1% of their market, figures reach 30% in African markets (reaching as high as 50% of all available medicines in some countries).

Worse yet, in Africa, counterfeit medicines are likely to focus on products most in demand for the treatment of endemic diseases (malaria), chronic diseases (tuberculosis, diabetes, hypertension ….), and devastatingly lethal diseases (AIDS). For example, two thirds of all antimalarial drugs sold on the continent are falsified, for a disease that kills on average over one million people each year, 80% of them in Sub-Saharan Africa alone.

We must take into account that health policies, as are medicines, have always been a source of political competition worldwide, regardless of pharmaceutical or medical aspects. This principle is often used by industrialized countries to maintain their rank within the alliance of great nations. Nowadays, organizations (NGOs, IGOs,…) and institutions of defense and financing of human health such as the WHO, the Global Fund, the Fondation Chirac, the Bill & Melinda Gates Foundation, are mobilizing to improve access to safe medicines wherever they are lacking and in the exclusive interest of public health.

Moreover, the evolution and development of the pharmaceutical industry in emerging countries like China, India, Brazil, Russia, Turkey, South Africa, Nigeria, Indonesia, and Thailand have also contributed significantly to overcoming the challenges of global production, geographical accessibility, and affordability of essential medicines. However, it would be a shame to allow counterfeit medicines to increase exponentially at the hands of mafia networks, which often take advantage of the vulnerability of countries or emergency regulations and decisions at the international level (compulsory licensing, the Doha declaration, parallel imports … .. ) to accomplish their dirty work.

To fight falsified medicines at all levels (networks, channels, trafficking, local markets…), we need to mobilize global resources, with the support of national and international political will.

Such political will must first be nourished by strong and coordinated commitments. Then it must be rendered concrete through consistently consensual legal provisions, and finally be complemented by sustainable actions that are supported by all.

Dr. Aboubakrine CARS

Chairman of Private Pharmacists’ Union of Senegal

Secretary General of the Inter-African Association of Pharmacists (Ispharma)

SG of the Permanent Secretariat of the Pharmaceutical Forum International (FPI)

Priorities in the fight against falsified medicines:

On the African continent, throughout regional and subregional institutions, such as the African Union, the West African Economic and Monetary Union (UEMOA), the Economic and Monetary Community of Central Africa (CEMAC), The Customs and Economic Union of Central Africa (UDEAC), the cornerstones and priorities of the fight are threefold:

➢ At the Legislative and Regulatory level:

1 / the development of coordinated laws and regulations to streamline litigation (through the use of different emergency procedures), to assess damage in relation to the harm caused to the licensee or patent holder, and to make provisions for more deterrent and coercive fines and prison sentences.

2 / the development of new offenses in the Customs Code penalizing the importation, exportation, trading, and transit of counterfeit goods and giving Customs full jurisdiction over suspected counterfeit products and the capacity to appeal directly to the Public Prosecutor.

3 / drawing up and/or updating within the Health Code of legal, regulatory, and disciplinary measures that are context-specific, coordinated, and valid in all member countries of the sub-regional or regional institution.

➢ At the communicative, informational and educational level:

1 / the development and creation of tools adapted to informing and raising awareness of the different target audiences (government, national and/or community institutions, opinion leaders, public health officials, and even counterfeiters)

2 / organizing seminars and workshops and/or strengthening the capacity of institutional enforcement authorities (customs, police…) in terms of detection, quality control, and traceability of medicines.

➢ At the health and socio-economic level:

1 / encouraging local production of essential medicines that are geographically and financially accessible.

2 / harmonizing international financial and technical support for the implementation of horizontal projects and programs according to the principles of the 2005 Paris Declaration.

3 / the adoption in the different regional and sub-regional areas of principles harmonized according to GMPs, GPDs and Pharmacovigilance (currently part of the WAEMU since July 2010 with the development of the GMP Guide).

4 / The creation of national committees in all the countries of the different regional and sub-regional areas. This would include pharmacists, but also the various State departments and services involved in tracking and enforcing laws against counterfeiters and sellers of falsified medicines.

The African pharmacist has a major role to play in this great undertaking, through his continuing education and that of his agents; through information and awareness campaigns for his patients/clients on the complexity of drug stability, as well as the dangers of consuming counterfeit medicines including those purchased in illicit channels and on the Internet; and finally through the advice he offers his patients.

We have benefited, as others, from technical and financial support to strengthen our capabilities particularly in the field of drug quality control at the Central Humanitaire Medico-Pharmaceutique of Clermont-Ferrand. Today, our priority is on this area of control along with pharmacovigilance in order to ensure the quality of the pharmaceutical care offered to our population.

This is the moment to encourage and congratulate institutions such as the Fondation Chirac and the Council of Europe, which, with the Cotonou Declaration and MEDICRIME have finished bravely establishing the basis for this global desire to fight the perpetrators of the genocide of fake medicines.

“Fear has changed sides.”

Together, with ethics, equity, solidarity, and justice as their sole weapons, the determination of just men will soon overcome the greed of the merchants of death.

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