BRUSSELS – Efforts by the European Union to insert strong provisions on pharmaceutical patents in a series of free trade agreements it is negotiating could imperil access to medicines in developing countries, global public health activists have alleged.

As part of trade talks being conducted with India, Colombia, Peru and a regional grouping in south-east Asia, EU officials have proposed that drug-makers should benefit from a robust intellectual property regime. National regulatory authorities in the countries concerned would be prevented for lengthy periods from using data provided by a company that holds a drug patent in order to authorise a generic version of that medicine.

In the cases of Colombia and Peru, such ‘data exclusivity’ would apply for up to 11 years, according to recommendations from the European Commission.

Germán Holguín, director of Colombian organisation Misión Salud, argued that this provision “would have devastating effects on access to medicines and health in general in our region.”

If the proposal is enforced as part of a free trade agreement, he predicted that the supply of affordable drugs in the Andean countries would be severely reduced. As generics are on average four times cheaper than branded drugs and sometimes up to 35 times cheaper, he warned that any measure to restrict their availability will have “horrible consequences” in a region with widespread poverty.

“The agreement between the European Union and our countries could amount to a lot of suffering and a lot of loss of human life,” he added. “Let us make no mistake about that because the problem is that serious. We did not expect such grotesque and offensive treatment by the European Commission.”

“We did not expect such grotesque and offensive treatment by the European Commission.” – Colombian health worker

According to Holguín, the Commission is seeking more exacting standards on IP than the US wished to include in the free trade agreements it sought with Latin American countries in recent years. Studies carried out in Colombia in 2007 predicted that the approach favoured by the US trade negotiators could increase the price of medicines by at least 46 percent and add $1 billion to Colombia’s annual spending on public health.

A detailed analysis of the European Commission’s new proposals contends that they go beyond the World Trade Organisation’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

Xavier Seuba from Pompeu Fabra University in Barcelona, who wrote the analysis [pdf], noted that TRIPS grants national governments particular leeway to decide on how IP rules should apply to medicines. By contrast, the Commission’s proposals advocate “a rigid and extremely precise framework for the measures and actions states must adopt and implement regarding intellectual property,” he said.

Seuba also raised concerns about how seizures of medicines by customs authorities could become more frequent as a result of the EU’s strategy to incorporate IP chapters in the free trade agreements it concludes with countries in the wider world.

Such a seizure occurred last month, when authorities in the port of Rotterdam blocked a consignment of losartan, a treatment for high blood pressure, that was being shipped from India to Brazil. Although losartan is a legal generic drug, the seizure took place after an unnamed company claimed to hold the patent for it in the Netherlands.

Seuba argued that the draft free trade agreement that EU officials are discussing with Colombia and Peru will enable pharmaceutical firms to hinder the transport of generic medicines in a wide variety of cases. Once more, he said, the EU is seeking powers additional to TRIPS, which largely restricts the use of seizures for counterfeit goods, not for generic medicines.

“The European proposal to the Andean Community enables the right-holder to block the importation, exportation, re-exportation, entry or exit of goods suspected of infringing any intellectual property rights in the customs territory,” Seuba told a meeting in the European Parliament on 17 February. “This represents a dramatic broadening of the required measures and grants a tremendous power to the title-holders, who will be able to block rival goods alleging a supposed infringement of an IP right.”

The trade talks between the EU and Colombia and Peru were launched in 2006. Bolivia and Ecuador – two other countries in the Andean Community – originally took part in the talks. Yet after their left-leaning governments indicated their unease with measures advocated by the Commission, the latter announced in late 2008 that it was only continuing to negotiate with Colombia and Peru.

Evo Morales, the Bolivian president, has stated that the EU’s decision will weaken regional integration in the Andean Community. In a letter sent to the European Commission last month, Morales said that rather than fully liberalising its trade with the EU, Bolivia would prefer a less onerous commercial accord which places “no limits on our right to define our national policies on important issues such as investment, services, intellectual property and public procurement.”

Serge Le Gal, an EU trade official, denied that the Commission is trying to drive a wedge between the different members of the Andean Community. Referring to political tensions between the Colombian government, which takes a broadly neo-liberal approach to economic policy, and more socialist-oriented administrations in Latin America, he asked: “Is this the fault of the Commission? We have to make choices and go ahead.”

EU Proposal for Asia

The proposals that the Commission has prepared for its negotiations with India and the 10-country Association for South East Asian Nations (ASEAN) have similar clauses on data exclusivity as those recommended for Peru and Colombia. But in the case of ASEAN, the exact length of the exclusivity desired by the Commission has not yet been stipulated. A copy of the EU proposal is available here.

Alexandra Heumber from the humanitarian group Médecins Sans Frontières (MSF) warned that any move to limit the use of generic medicines would be to the detriment of people requiring antiretrovirals (ARVs), the main drugs used for treating HIV/AIDS.

Because patients have been known to build up resistance to standard ARVs, doctors have to prescribe new varieties known as ‘second-line’ treatments, she added. In Thailand, these new varieties can be as much as 22 times more expensive than the most commonly-used ARVs.

“Middle-income countries like Thailand are trapped in a double bind,” she said. “Because they have manufacturing capacity, they are heavily pressured by pharmaceutical companies, backed by the US government, to increase intellectual property protection.”

“At the same time,” she added, “they are viewed as emerging markets with rich elites representing lucrative markets and are excluded from differential pricing policies offered to least-developed countries. The reality, however, is that HIV/AIDS is essentially a disease of the poor. Public health services in these countries are unable to pay the high prices demanded by pharmaceutical companies.”

The European Federation of Pharmaceutical Industries and Associations, an umbrella group for manufacturers of branded drugs, did not respond to requests for a comment.

[Update: The South Centre has issued a warning to African nations that signing the Economic Partnership Agreements with the European Union may bring more losses than gains and offered recommendations for the talks. In addition, the Trade Law Centre for Southern Africa reported that EU Trade Commissioner Catherine Ashton was due in Botswana this week for trade talks.]