EU parliament rejects anti-generics ACTA

In a huge boost to makers of generic medicines, the European Union (EU) parliament on Wednesday rejected a treaty agreement that could have given these companies and the patient groups fighting for low-cost medicines a severe migraine.

The Anti-Counterfeiting Trade Agreement, or ACTA, sought to encourage EU customs authorities to seize in-transit legitimate generic medicines from countries like India if their innovators enjoyed patent protection in the EU countries.

On mere allegations, including those brought by competitors, generic manufacturers allegedly infringing a trademark or patent could have faced a destruction of goods or criminal proceedings under ACTA.

The agreement also had a provision for third-party liability and could have penalised the non-governmental organisations distributing these generics to people in developing economies where patents had not been granted to the drugs.

In 2008 and 2009, more than 18 in-transit consignments of generics from India — manufactured by companies like Aurobindo, Cipla, Dr Reddy’s and Ind-Swift Laboratories — were seized at the airports in Paris and the Netherlands on the ground of being ‘counterfeit’ since their innovators enjoyed patents in France and the Netherlands.

The seized drugs, meant for treating AIDS, blood pressure, Alzheimer’s and other diseases, were bound for markets like Columbia, Brazil, Peru and Nigeria, which had not granted patents to the innovators.

Pharma industry officials welcomed the move.

“It (ACTA) could have had a negative impact on access to medicines. This (the rejection by the EU parliament) allays our concerns and apprehensions and vindicates our stand on the issue,” said D G Shah, secretary general, Indian Pharmaceutical Alliance.

But there is no gauging the impact on exports just yet, said Shah, pointing out that the treaty clauses could still come in the way of the industry in the US and other countries that have signed it.  

The US, Australia, Canada and Japan signed the ACTA last year, while 22 members of the EU signed it in January this year.

Leena Menghaney, campaigner for access to medicines with humanitarian group Medecins Sans Frontieres, said ACTA threatens the production and free movement of safe generic medicines between developing countries.

Experts, in fact, say the legislation is not designed to deal with unsafe medicines as it is about intellectual property (IP).

A New Delhi-based IP expert said ACTA tended to read generics mistakenly as counterfeits, which is not the case. “Generics are not substandard or illegal. Counterfeit is an IP issue. Just because a drug holds a patent in the country through which the generic is passing does not mean it is counterfeit.”