Anti-Counterfeiting Initiative Aimed At Protecting African Medical Industries

By Wagdy Sawahel for Intellectual Property Watch
West African people should establish a medical anti-counterfeiting task force to promote local herbal medicines by protecting indigenous knowledge and genetic property and establishing benefit-sharing systems in addition to tackling the spread of cheap, fake medicines that are causing an unnecessary loss of life, according to the communiqué from a recent meeting in Accra.

This was announced at workshop held in Accra, Ghana from 21-23 July under the theme “Protecting the consumer against counterfeit products through interagency and sub-regional collaboration,” organised by the Food and Drugs Board in collaboration with the Ghanaian Institute of Packaging and the coalition against counterfeit and illicit trade.

“Aside from being a threat to human life, counterfeit goods deny genuine products of their rightful market share, cost government significant amounts in lost tax revenue, threaten jobs and create lack of consumer confidence in products,” Ghanaian President John Agyekum Kufuor said at the opening session of the workshop. But nations are struggling with how to address the problem while also developing locally advantageous solutions.

The World Health Organization (WHO) currently defines a counterfeit drug as: “One which is deliberately and fraudulently labelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with correct ingredients, wrong ingredients, without active ingredients, with incorrect quantity of active ingredients or with fake packaging.”

Although the magnitude of counterfeiting is difficult to calculate, some experts have estimated that 10 percent of the global pharmaceutical supply may be counterfeit, rising as high as 25 percent in developing countries. A survey conducted by WHO between January 1999 and October 2000 found 60 percent of counterfeiting incidents occurred in developing countries and 40 percent in industrialised nations.

Task Force

To protect the local medical industries, the task force will prepare a mechanism for reporting counterfeit issues including its harmful effect on local economy and health and launch awareness creation programmes as well as advising governments and local companies on ways to increase the use of security features on their products including medicines, cosmetics and medical devices.

According to President Kufuor, this protection of intellectual property rights for local medical industries will sustain socioeconomic development that depends on investment and the growth of local industries, entrepreneurs and innovators who are willing to invest the capital needed to create brands and copyrights and to deploy money into research and development necessary to produce products which are accorded IP rights.

To promote international investment, the task force will help West African countries to comply with international standards set by the WHO, World Intellectual Property Organization (WIPO), and the International Trademark Association (INTA), a US-based industry group.

This is intended to increase investment by foreign research-based reputable multinational pharmaceutical manufacturers which are typically reluctant to manufacture their products in countries where counterfeiting is rampant, as they fear an inability to protect their IP rights, according to Courage Quashigah, Ghana’s Minister of Health. It is unclear how the task force will help grow local innovation and local IP rights.

Using the existing laws on counterfeiting and piracy, the task force will prepare a new anti-counterfeit/piracy legal and regulatory framework to cover all product categories and with graded punitive measures to recognise different levels of offence, according to the Accra communiqué.

Besides having a permanent secretariat and four subcommittees, namely, legislation and regulation, public education and awareness creation, information and intelligence gathering, and human resource and capacity development, the task force is expected to have representatives from government, industry, trade associations and consumers.

With a contact person nominated from Ghana to act as the liaison, the task force should derive its powers from the presidency by executive and legislative instruments, and should form a network with authorities within the sub-region and coordinate its operational activities.

Industry, government and regulators should identify the type of technology to be used for detecting fake medicines within three months, sourcing for proposals to be done within six months, while piloting of identified technologies should be done within nine months.

Fighting Drug Counterfeiting by Increasing Legitimate Drug Access

But some have raised concern that efforts also include improving access to medicines in developing countries. Speaking to Intellectual Property Watch, Morad Ahmed Morad, a professor of medicine at Tanta University in Egypt, said “the main reasons for increasing fake drug trade in developing countries are the high cost and short supply of important medicines.”

Morad added that “if the problem is to be tackled at its source, controversies surrounding the WTO [World Trade Organization] Trade-Related Aspects of Intellectual Property Rights [TRIPs] agreement and the debate over access to medicines for developing countries should end in favour of finding a way for providing developing countries with the required supply of needed drugs at affordable price.”

To solve this problem, Morad called for implementing the new WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property approved at the annual World Health Assembly held from 19-24 May.

The strategy called for improving access to all health products; and securing sustainable financing for R&D on diseases that disproportionately affect people in developing countries as well as outlining practical measures for using the intellectual property system to promote innovation to achieve public health goals, particularly on diseases which disproportionately affect developing country or underserved areas.

On the other side, Kristina Lybecker, a researcher at Department of Economics and Business of US-based Colorado College told Intellectual Property Watch “I believe that the problems of pharmaceutical counterfeiting are best addressed by securing the pharmaceutical supply chain, a process that is seemingly independent of the WTO’s TRIPS Agreement.”

Lybecker argued that the most effective ways to fight pharmaceutical counterfeiting include reducing the number of links in the supply chain between manufacturer and consumer. She added that nations should enforce their existing anti-counterfeiting legislation, punishing those who are caught as well as educating consumers about the dangers of counterfeit drugs, the importance of reliable suppliers, and how to recognise medicines that may be counterfeit.

Local Innovation and Protection for Local Herbal Medicines Industry

Hassan Moawad Abdel Al, former president of Alexandria’s Mubarak City for Scientific Research and Technology Applications, Egypt told Intellectual Property Watch, “it is unfair to provide legal protection in Africa for pharmaceutical products produced by the international drug and cosmetic industry and at same time some of these products have been produced from medicinal plant genetic materials that have been taken illegally from Africa and commercialised without any benefit sharing.”

Abdel Al indicated that the task force must focus its activities in launching a publicity campaign to make the public aware of indigenous knowledge or genetic property taken illegally from them as well as promoting sustainable use of traditional medicinal plants which is the only source of medication for about 75 percent of all Africans.

According to Abdel Al, the task force should also organise training programmes for promoting the conservation of the rich genetic diversity of Africa that offers new incentives to stakeholders in the new bioactive compounds found in botanicals.

Abdel Al said the task should focus on creating and protecting local agribusiness through the production of finished products rather than the export of raw materials as well as developing models for benefit sharing and formal systems for intellectual property rights which can be claimed on patents, through trade secrets, copyrights, trademarks. It also should focus on plant breeder’s rights and informal way of protecting IP rights through negotiating a know-how licence, which does not give worldwide rights or copyright but can be much more cost effective and acknowledges the partnership, he said.

Abdel Al concluded, “The fund generated from benefit-sharing schemes and intellectual property rights originating from the use of African medical plants should be used for investment in healthcare infrastructure which will help Africa to produce some of its needed drugs.”

Wagdy Sawahel may be reached at info@ip-watch.ch.