People know about Somalian pirates and the havoc they are wreaking on the Indian Ocean. What is less well known are the adventures of custom officials from the European Community, who are confiscating shipments of medicines destined for developing countries.

Officials say they are preventing intellectual property violations and cracking down on potentially hazardous counterfeit drugs. EJN’s Percy Makombe says it’s an attempt to disrupt legitmate trade in generic medicines.

India has had enough of these seizures and is suing the European Union (EU) at the World Trade Organisation. India is angry that big pharmaceutical companies have been taking advantage of EU’s tough patent laws to stop the transit of generic drugs destined for developing countries.

In 2008 alone, Dutch authorities made 17 seizures of medicines destined for Ecuador, Peru, and Nigeria, amongst others. In May a shipment of the generic Amoxicillin was seized in Germany on its way to Vanuatu, a little-developed country in the Pacific. These seizures have sparked concern, not least because of their potentially disastrous implications for public health and universal access to medicines.

Rajeev Kher, India's Secretary of Commerce, believes the seizures are “an attack on the Indian generics industry”.

The debate about intellectual property and access to medicines became heated at the TRIPS Council meeting in June 2009. Developing countries protested at the seizure of the generic antibiotic Amoxicillin by customs officials in Germany. The seizure of the 3, 047, 000 tablets took place in Frankfurt before they could be shipped to Vanuatu. Brazil and India have led the protests.

Amoxicillin is an antibiotic used to treat a broad range of bacterial infections. Developing countries were therefore angry at the seizure, given the importance of the drug to public health. They expressed their disappointment at the European Commission for undermining their ability to obtain cheaper generic medicines.

The reason offered for the seizure was that the drugs violated trade mark rules. Surprisingly, despite this “violation,” the drugs were eventually released a month later. This came after GlaxoSmithKline, the company holding the patents, told German custom authorities there had been no trademark infringement after all.

Civil society organisations, including Health Action International, Oxfam International and Third World Network, are demanding a full explanation. They are also calling on the European commission to take immediate steps to guarantee that its laws and bureaucratic bungling do not deny developing countries timely access to essential medicines.

If this were an isolated incident, it could simply be blamed on overzealous custom officials; but that is not the case. A pattern of similar incidents appears to be emerging within the European Commission. Last year Health Action International took on the Dutch government through the Freedom of Information Act. The request filed under this Act revealed that there had been 17 seizures by the Dutch authorities in 2008. The medicine was for diseases ranging from cardiac ailments to dementia.

The authority to seize these drugs came from the European Commission Council regulation No 1383/2003 of 22 July 2003. This regulation gave custom officials the authority to take action against goods suspected of infringing certain intellectual property rights.

Patents give those who hold them a monopoly on the production and sale of an invention. According to TRIPS rules, a state is obliged to grant patent owners at least 20 years of exclusive commercial rights to sell inventions such as medicines. While this aims to protect investments in research and development, it allows patent holders to keep prices of patented drugs artificially high, putting them out of reach for many.

Recognising the necessity of generic competition in developing countries to allow access to treatment, and the huge need generated by AIDS, malaria, TB and other public health problems, a landmark decision was reached in 2001 – the Doha Declaration on TRIPS and Public Health.

This declaration re-affirmed the option for WTO member states to use all flexibilities provided in the TRIPS agreement to ensure access to affordable medicines, and to prevent patent monopolies stopping access to medicines where they are needed for public health. Article 4 of the TRIPS agreement says the Agreement “can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, access to medicines for all.”

In particular this gave countries the authority to use the flexibilities provided in the TRIPS Agreement in the interests of public health, including:

• providing for compulsory licensing or the right to grant a license, without permission from the license holder, on various grounds including public health;
• providing for parallel importation or the right to import products patented in one country from another country where the price is less;
• providing for early working, known as the Bolar provision, allowing generic producers to conduct tests and obtain health authority approvals before a patent expires, making cheaper generic drugs available more quickly at that time.

In short, therefore, member countries have the authority to use these flexibilities when it is necessary to protect public health and to promote access to medicines.

In 2000, 39 pharmaceutical companies, mainly US-based, threatened to sue the South African government for passing the Medicines and Related Substance Control Amendment Act. This is a law which makes it possible for South Africa to utilise TRIPS flexibilities. The case received wide publicity. Civil society organisations and the public joined hands in support of the law and called the behaviour of pharmaceutical companies into question.

The companies eventually withdrew their case after US president Bill Clinton issued an executive order stating that the US could not support a policy hindering access to medicines for people living with AIDS in Africa.

The EU claims that their custom actions actually save lives in final-destination countries, usually developing countries, as it stops fake drugs from reaching those countries. If anything, their actions serve to delay and, in some cases, prevent developing countries from accessing affordable generic medicines.

As Brazil pointed out at the TRIPS Council, “The TRIPS Agreement does not allow the detention of goods in transit. The seizure of goods in transit on grounds that they may be violating IP rights in the country of transit violates the principle of territoriality, a keystone of the international IP system.”

India, for example, says it has closely followed the different grounds mentioned by the EC for it seizures. The reasons given include cracking down on counterfeit drugs and substandard, potentially hazardous products, and preventing patent violations. According to Indian officials, allegations of drug trafficking were made only three months after a particular seizure had been made.

“These are serious allegations,” an Indian official said. “And we take serious exception to such unsubstantiated and wild allegations. The fact that the drugs were subsequently released is proof that the allegations were baseless.”

The seizure of medicines continues unabated at European Commission ports. There is a pattern forming in which barriers are created to disrupt legitimate trade in generic drugs. Given the importance of generic drugs to developing countries, it is having an adverse impact on their public health.

The UN Special Rapporteur on the Right to Health noted that nearly 2 billion people lack access to essential medicines partly due to their high costs. Improving access to medicines could save 10 million lives a year, in particular 4 million in Africa and South East Asia.