Isolda Agazzi

GENEVA, Jul 19 2010 (IPS) – The World Health Organisation (WHO) agrees that the anti-counterfeit legislation that has been adopted or that is under consideration in East Africa threatens the accessibility of affordable generic medicines.

Richard Laing: There is considerable concern about ACTA after the recent seizures of legitimate generic drugs in Europe. Credit: Isolda Agazzi/IPS

National legislation on counterfeit medicines has to be very carefully drafted. If the definition of counterfeits is too wide, it may lump together actual counterfeit and fake medicines with generic medicines, Hans Hogerzeil, WHO director of essential medicines and pharmaceutical policies, told IPS in an interview.

Examples of laws that err in this regard are the draft laws in Kenya and Uganda that have been proposed but have been challenged and are now being reviewed , said Hogerzeil.

Dr. Richard Laing, editor of the WHO journal Essential Medicines Monitor , said there may be a disjunction between the concerns of health and trade (in these bills and laws). Our national programme officers are giving information to the countries that are involved to make the best choices .

Hogerzeil added that, WHO is concerned about the public health aspect of counterfeit and fake medicines .

While WHO leaves the intellectual property aspect to the other organisations, such as the World Intellectual Property Organisation (WIPO) and the World Trade Organisation (WTO), it is consulting with member states to draft model legislation, including a model definition for counterfeit medicines, which will specifically deal with public health and prevent that anti-counterfeit legislation is misused to frustrate the trade in legitimate generics .
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Hogerzeil was one of the speakers at a technical symposium on access to medicines jointly organised by the WTO, WHO and WIPO on Friday Jul 16 in Geneva.

Michelle Childs, director of policy and advocacy at Médecins Sans Frontières (MSF), said that, in Kenya, MSF relied on a 2001 Kenyan law that allows import but now we are under threat because of the anti-counterfeiting law, which has an ambiguous definition of counterfeit.

MSF is one of the largest international medical and humanitarian aid organisations in the world.

Our HIV projects rely on the importation of medicines but also on the use of Kenya as a hub for our projects in Africa. It must remain viable, Childs explained.

She also clarified that, by far the biggest problem we have is substandard and low-quality, rather than fake or counterfeit medicines.

Patrick Durisch, intellectual property officer at the Berne Declaration, explained that counterfeiting is a violation of trademark law and it can happen even in the case of an excellent product that does not harm anybody.

In contrast, substandard and bad quality medicines are a serious public health problem. Therefore this problem should not be addressed by adopting stricter intellectual property provisions, but by strengthening national regulatory authorities, for example.

The Berne Declaration is a Swiss nongovernmental organisation specialising in trade and intellectual property issues. It has actively lobbied governments during the last round of the negotiations on the Anti-Counterfeit Trade Agreement (ACTA) that took place in Switzerland at the beginning of July.

Industrialised countries fight against counterfeiting through the enforcement of stricter intellectual property rules has taken on a new momentum in the past two years.

ACTA negotiations, which started in mid-2008, involve the EU, U.S., Switzerland, Australia, Canada, Japan, Korea, Mexico, Morocco, New Zealand and Singapore.

At the regional level, draft anti-counterfeit legislation has been adopted in Kenya and drafted in Uganda, Zambia, Malawi and at the level of the East African Community.

Laing confirmed that there is considerable concern about ACTA, particularly because of the (recent) seizures of generic drugs in Europe. The devil is in the details.

MSF, whose procurement centre is in Europe, is also concerned about the seizures of generic drugs in 2008 and 2009 in the Netherlands that were en route from India to Brazil, just to be blocked after being labelled as counterfeit by the Dutch custom authorities.

Yehudah Livneh, chairperson of the intellectual property committee of the International Generic Pharmaceutical Alliance (IGPA), agreed that the seizure of generic pharmaceuticals in transit is a real problem. Custom authorities should not be the ones enforcing patents. They cannot understand these issues.

IGPA is an alliance of the major generic industry organisations, with members from the U.S., Canada, Europe, India and Japan.

The East African legislation also involves customs in decisions about whether drugs are counterfeit or not.

Livneh pointed out some of the complexities of patents: Most drugs are covered by 10, 20 and more patents per country. Some patents will be upheld by courts, others not. Also, patents are not the same country to country. It is difficult to find patents in Ghana, for example. Now WIPO has put a database online; it is wonderful, but not sufficient.

Durisch advocated for a radical change in the system: Everybody agrees that patents are a problem, but nothing is done to change it, he told IPS in an interview. Generics are the solution found to circumvent patents but the system has never been fundamentally challenged.

He believes the same system cannot apply everywhere as resources differ from state to state. Exceptions should be maintained for poorer countries. But, the governments that discuss today how to improve access to medicines are the same ones that draft the anti-counterfeiting laws. And the East African draft laws are even stricter than ACTA, Durisch pointed out.

Livneh confirmed that producers of generics are in firm agreement that we need to maintain the quality of generics. There is no argument there.