Anti-counterfeiting initiatives might have a negative impact on access to medicines while not addressing the problem of fake medicines, particularly in developing countries, according to panellists at a recent event organised by the Open Society Institute.

Confusion between legitimate generic medicines, poor quality medicines and those illegally copying the trademark of a brand-name product could have a devastating impact, and a precise definition and scope of counterfeiting is needed, they said. IP enforcement measures should only be used against drugs with trademark violations, they added.

According to a Médecins Sans Frontières document, counterfeit medicines are products that are packaged to intentionally look like a legitimate product but are not. This is a trademark infringement. On the other hand, substandard medicine is a legitimately produced medicine that does not meet the standards set by the relevant drug regulatory authority. This is an issue of quality control. Finally, a generic drug is a legitimately produced medicine that is the same as the original brand-name product usually not under patent and contains the same active ingredients.

Generics are generally much cheaper than the patented version and play a significant role in providing essential medicines affordably to poorer population.

“When we speak about anti-counterfeiting initiatives, we are basically referring to the global IP enforcement agenda,” Sangeeta Shashikant, senior legal advisor at the Third World Network, said at the 25 September event.

According to Shashikant, there is a strategic “forum-shifting” concerning counterfeit, which is now addressed in several instances. It is a focus of the Group of Eight industrialised countries, one of whose key agenda items is technical assistance to developing countries on global IP enforcement. The issue also is being addressed in the plurilateral negotiation for an Anti-Counterfeiting Trade Agreement (ACTA).

In addition, anti-counterfeiting is a focus of the International Criminal Police Organisation (Interpol), whose activities in this area have led observers to express concern about the scope of the definition of counterfeiting being used by the agency. The Brussels-based World Customs Organization too took a decision in 2006 to develop provisional standards for uniform rights enforcement, though those efforts have been scaled back under pressure.

The issue is also being addressed by the World Intellectual Property Organization (WIPO) whose Advisory Committee on Enforcement will meet in the first week of November.

At the national level, there is a push for IP enforcement measures in developing countries, especially in Africa, Shashikant said, as in Kenya, for example, which passed an anti-counterfeiting bill while Uganda is discussing it. Tanzania and Zambia might be considering it, said Els Torreele, director of the access to essential medicines initiative of the Open Society Institute.

Counterfeiting should not encompass all IP Infringements

The problem, according to Shashikant, is the scope of such legislation. In the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), counterfeit is defined as pertaining to trademark infringement. In the Kenyan bill, it goes beyond TRIPS by referring to all IP infringements such as patents, trademarks, copyrights, industrial designs, and even plant variety protection. This has never happened before, she said, that a violation of plant variety could be called a counterfeit.

Such legislation does not recognise that there is a difference between trademarks and patents. Patents protect the invention, the subject matter and rights and obligations are different.

The Kenyan bill also goes against existing IP legislation on specific areas of IP rights (like copyright) whose limitations and exceptions are not recognised in the counterfeit bill, she said.

The quality of medicine should be dealt with by drug regulatory authorities, not customs authorities, as customs officers do not have the capacity to determine if a good is infringing IP rights, she said, arguing that IP infringement should be addressed by IP offices.

Customs officials have no capacity to judge a quality of a medicine, agreed Partha Satpathy, counsellor at the Permanent Mission of India. Mere suspicion from the IP right holder can lead to goods seized at the border and detained for months, said Shashikant. This happened several times over the past year in Europe, mainly the Netherlands. There is a question of what penalty there is if a wrong decision is taken, said Satpathy, who said counterfeit is strictly a trademark issue.

When it comes to public health, it is dangerous when every kind of IP infringement is assimilated to counterfeit and IP rules need to be tailored in the context of public health. TRIPS flexibilities are important to protect public health, he added, urging countries to avoid “TRIPS-plus” measures (with more stringent IP protection measures than in TRIPS).

Essential medicines should also not only be focused on tropical medicine (like malaria) in developing countries, but also on non-transmissible ailments (like cancer and chronic diseases) that are a growing concern there, added Satpathy.

Confusion between IP Enforcement and Safety

There must be no confusion between substandard drugs and generic drugs although there is sometimes a deliberate attempt to perpetuate the confusion, said Elio Cardoso, counsellor at the Permanent Mission of Brazil.

It is important that even if a branded or generic drug has not been licensed for international trade by the drug regulatory authority of one country, it can be licensed by the authority of another country and the transit of this drug must be guaranteed, Cardoso said.

The focus should be on access to quality medicine, he said, as patients are the main victims of fake drugs, not the pharmaceutical industry. “The preoccupation should be about the effectiveness of the medicine never on the profit of the industry,” he said.

All participants agreed on the fact that access to safe medication should not be included in an IP framework but should be addressed in the public health framework. “Access to medication at the World Health Organization (WHO) should focus on issue of public health and not on IP questions,” said Cardoso.

Moreover, the nature of the infringements in seizures of shipments is not clear, said Shashikant, for example, WHO has no data about seizures. “If there is no data, no concrete evidence, why do we have an entire body dealing with counterfeit?” she asked.

For Michelle Childs of Médecins Sans Frontières, the question is to access existing treatments but also new treatments. With anti-counterfeiting legislation, “we are in danger of ending up with the worst of both worlds, pushing IP rules, which are very effective at stopping access to life-saving drugs but are very bad at stopping or preventing fake drugs,” she said.

“The world is changing,” Childs said. India, the world’s biggest supplier of lower-priced generic drugs now has new IP rules and some new HIV drugs are under patents. “How do we get access to new drugs?” she asked.

Council of Europe Gets in the Anti-Counterfeit Game

Bart Wijnberg, adviser for the Dutch ministry of health, mentioned that the Council of Europe, in a pharmaceutical crimes initiative, is at the end stages of making a draft convention [pdf] against counterfeiting of medical products, and that this draft convention took a very staunch public health approach.