A week after African ministers of health adopted a treaty for the establishment on the African Medicines Agency, an international conference held on the side of the World Health Assembly denounced the rampant and increasing issue of fake medicines in Africa, and the lack of adequate action and political will. The Benin president said Benin’s efforts to fight traffickers is so far unsupported, and called developed countries to commit to the fight. Other speakers insisted on the importance of local production of medicines, and the need for biting legislation to defeat fake medicines.

One child dies every five minutes as a result of fake anti-malarial medicine, Michaelle Jean, general secretary of the International Organisation of la Francophonie (Organisation Internationale de la francophonie – OIF), said at the start of an International Conference (in French) on access to quality medicines and other medical products in francophone Africa. The event took place on the margin of the World Health Assembly, on 22 May.

The conference was organised in collaboration with UNAIDS, and supported by the World Health Organization. A Declaration [pdf] containing actions items to fight fake medical products is currently being signed by countries.

Last week, African ministers of health, who were meeting as a Working Group of the Specialised Technical Committee on Health, Population and Drug Control adopted a treaty for the establishment of the African Medicines Agency (AMA), according to an African Union press release.

The AMA was praised at the OIF conference, which was meant to bring to the international attention the issue of falsified and sub-standard medicines, everywhere in the world, but in particular in francophone Africa, and what is needed to curb the rampant criminal trade.

Michel Sidibé, executive director of UNAIDS, opening the conference, said Africa is bearing 25 percent of the global weight of disease, but only produces about 3 percent of the medicines it needs. He called for a criminalisation of fake medicines manufacturers and distributors.

Benin Committed, Asks for Sincerity, Jibes Industry

Benin President Patrice Talon insisted on the fact that the primary victims of fake medicines are the poorest in the population. If nothing is done about fake medicines, he said, undefeated illnesses and microbes will not fail to become rampant everywhere in the world, including in developed countries.

The scourge of fake medicines continues to wreak havoc, and is only increasing, he said. the 2009 Cotonou Declaration [pdf] (Benin) against the traffic of falsified medicines, did not lead to a decrease of the traffic of fake medicines, as criminal organisations swiftly reorganised themselves he said, underlining the fact that the high prices of medicines is encouraging fake medicines consumption.

For the last two years, he said, Benin has committed to eradicate illicit fake medicines distribution channels, President Talon explained, adding that although the fight is far from over, the country has won significant victories.

Benin’s determination is irreversible, he said but the country on its own cannot win the fight against fake medicines, he said, calling for an international effort combining information, training, investment and sincerity.

He said the pharmaceutical industry has to stop developing production chains for the exclusive use of poor countries. Such discrimination is immoral, he said, and weakens the fight against fake medicines. Is it possible that in the same country some medicines are manufactured for the poor, which are not recommended for the rich, he said.

Some 70 to 80 percent of fake medicines are not manufactured in hidden corners, or in basements, he said. They are produced in known units, and in developed countries. They are not produced in small countries, in poor countries, he added. Developed countries have yet no real determination to fight fake medicines, he said.

For the last two years, Benin has launched into an implacable fight against the traffic of fake medicines, he said, adding that the war is a long way from being won but great victories have been achieved so far. However, he said Benin feels quite alone in this fight. In Benin, he added, some deputies are in prison because they were barons of the fake medicines traffic, as well as expatriates who were implicated in the traffic. He said Benin is facing “enormous pressure” to ease off the effort.

“This is very serious,” he said, adding that narcotic drugs trafficking seems less dangerous than the fake medicines traffic, why is it not possible to mobilise the same energy countries deploy to fight narcotic drugs trafficking to fight fake medicines, he asked.

Asked about specialised production lines for poor countries, the International Federation of Pharmaceutical Manufacturers and Associations told Intellectual Property Watch that the pharmaceutical industry is one of the most regulated industries around the world. The IFPMA vigorously denied any possibility of double standard.

[Updated:] “The R&D-based biopharmaceutical industry does not have double standards between developed and developing countries,” an IFPMA spokesperson said. “IFPMA members only manufacture medicines and vaccines that conform to highest quality standards for all patients.”

Better Awareness, Lack of Action

Jean reminded the audience of two resolutions taken by the francophonie countries about fake and falsified medicines, one in 2010 in Montreux (Switzerland), and the other one in Dakar (Senegal) in 2014.

She also noted the 2011 Council of Europe Convention Medicrime on the counterfeiting of medical products and similar crimes involving threats to public health, which entered into force on 1 January 2016. Jean deplored that only 12 countries have ratified the convention so far, while some 140 countries are concerned by fake medicines.

Despite a notable awareness raising, she said, actions which have been deployed are simply not matching the challenge. Some one million people perish each year because of fake or falsified medicines, she said, adding that all types of medicines are concerned. Every five minutes, she said, a child dies from a falsified anti malarial medicine.

The fake medicine traffic is very lucrative, she said, about 10 to 25 times more lucrative in fact than the traffic of cocaine, with a potential profit closing on US$200 billion. It is a financial windfall for organised crime and terrorist organisations, she added.

Fake medicines are a burning health emergency in developing countries and emerging economies, she said. Fake medicines risk undermining hard-earned progress accomplished in areas such as AIDS and tuberculosis, she said, adding that however, criminals are facing low risks in the absence of strong laws.

Claude Chirac, daughter of former French President Jacques Chirac, and vice president of the Chirac Foundation, said fake medicines kills more than malaria. The Foundation, which co-launched the Cotonou Declaration with African leaders, has been active in denouncing the issue, she said.

The international response is mainly composed of declarations of intent but remains insufficient, as illicit trade of fake medicines is thriving, she said. She called countries to join Medicrime, which she said entered into force thanks to the ratification by African countries.

War on Health Declared, No War on Pharma

At the beginning of the afternoon on 22 May, an expert meeting was organised. Marc Gentilini, of the Chirac Foundation on Access to Quality Medicines and Healthcare, and former president of the French Academy of Medicine, reported on the discussions. He underlined the need to raise the population awareness, as well as policymakers. Experts also recommended training for all health professionals, in medical and veterinary schools, for judges, policemen and customs officials. “The war against health has been declared,” he said, adding this war involves a widespread mobilisation of all actors, at all levels, adding that repression tools are necessary, and means for countries to destroy seized fake medicines before they are stolen by other traffickers.

He said fake medicine trafficking comes essentially from India and China, interpreting the statement of President Talon. Making a case against the pharmaceutical industry is a dangerous initiative on the short and long term, he said.

Raymonde Goudou Coffe, Health and Public Hygiene Minister of Côte d’Ivoire, advocated for the promotion of generic medicines, for cheaper medicines, and for local production of medicines. This was echoed by Jacqueline Lydia Mikilo, Minister of Health of Congo said the country is undertaking reforms including a central purchasing office for medicines, set up in August 2017, and efforts to create local production of medicines, with a first experience on anti-malarial medicines.

The importance of local production was also stressed by Benjamin Djoudalbaye, Head of Policy and Health Diplomacy at Africa Centres for Disease Control and Prevention, He called for technical assistance for countries, a strengthening of international collaboration, and support for regional harmonisation efforts.

Simon Kaboré, director of the African Essential Medicines Access Network (Réseau Accès aux Médicaments Essentiels), also suggested local production as a tool against fake medicines, which would allow for the traceability of medicines. He warned against TRIPS-plus measures in bilateral trade agreements, citing the European Union agreement on economic partnership in Africa.

He also said generic medicines produced under compulsory licences should not be considered as counterfeit, citing originator manufacturers lodging a complaint for patent infringement. Generic medicines can be challenged on their quality, he said, but not on their legality.

Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), said no country is spared from fake medicines. The most substantial increase of fake medicines is found in essential medicines, such as antibiotics, cardiovascular, AIDS medicines, and tuberculosis, but in essence all medicines are affected, he said.

The question of fake medicines has nothing to do with intellectual property, he said, it is a menace for public health and it is essential to understand how fake medicines penetrate legal supply networks. A concerted approach is necessary to fight the scourge, he said, underlining the advantages of public-private partnerships in the face of a vast and complex traffic, and porous distribution chains. He underlined the IFPMA’s initiative Fight the Fakes mobilising actors from the beginning to the end of the value chain.

Local Production Need Support

Aurélie Nguyen, managing director, Vaccines & Sustainability at Gavi the vaccine alliance, also reporting on expert discussions said accessible does not automatically means cheaper. It is sometimes difficult for local producers to deliver cheaper medicines than those imported, she said, underlining the needed support for local producers, in particular financial support to reach strict quality standards.

Anas Doukkali, Moroccan Minister of Health said the country as a history of local production and is trying to create a favourable ecosystem, in particular through fiscal and customs incentives, and investment premiums, to encourage generic, biosimilar and vaccine production (biosimilar medicines are medicines similar to biomedical product, since an identical copy is not possible).

Diane Gashumba, Rwanda Minister of Health said the country imports 90 percent of its medicines, but has a strict regulations and a quality control system. Rwanda is also investing in research, she said, and conducts clinical trials on imported medicines to measure their impact. Rwanda recently established a food and drug authority, she said, which is collaborating with agencies from other countries with more experience.

Isabelle Durant, deputy secretary-general of the United Nations Conference on Trade and Development (UNCTAD), said UNCTAD has been working for years with some countries to help them develop local production. The organisation provides legal and regulatory advice, she said.

Local production is interesting as it allows traceability of medicines and provides a country with the control over its production and the ability to benefit from that production. It is also important to work with governments on licensing contracts, she said.

She underlined the value of traditional medicines, and encouraged their protection so they could become an export product.

Franck Von Rompaey, UN Industrial Development Organization (UNIDO) representative in Geneva, said results are lagging behind in the fight against fake medicines, adding that pharmacies “on the ground” (par terre) are proliferating. He remarked on the loss of plant species, which is weakening the recourse to traditional medicine, and push population toward pharmacies on the ground. He said UNIDO has been helping member states facilitate access to quality pharmaceutical products, and said local production has a direct effect on economic development.

(Note, all statements were originally delivered in French)

Image Credits: Catherine Saez.