EU's anti-counterfeiting effort is having a potentially deadly side-effect.
As MEPs on the European Parliament's international trade committee, we are deeply worried that three consignments of Indian-manufactured generic medicines – seized last year while in transit in the EU – have been earmarked for destruction by EU authorities.
These consignments – of clopidogrel, rivastigmine and olanzapine – were being exported from India to other developing countries to treat patients with serious and life-threatening conditions such as heart attacks, strokes, Alzheimer's disease, Parkinson's disease and psychosis. Yet they were seized by Dutch customs authorities on the basis of alleged patent infringement.
Although these medicines are not under patent in India or in the destination countries, EU customs legislation still permits the destruction of these life-saving medicines. A humanitarian organisation, Médecins Sans Frontières (MSF), has highlighted several other recent cases of generic medicines in transit in the EU that have been detained, seized or destroyed. As MSF itself provides generic medicines to developing countries via its EU logistical bases, such actions may have a serious impact on its work.
We believe that at the root of the current wave of seizures is the blurring of the definition between legitimate generic medicines and illegal counterfeit medicines.
We entirely accept the European Commission's view that the EU needs an effective anti-counterfeiting policy and we fully support the important work of national customs authorities in preventing the illegal trade in counterfeit medicines.
It is vital to differentiate between illegal counterfeit medicines – which the World Health Organization defines as medicines having a false representation of identity and/or source – and legitimate generic medicines, which are, in most cases, simply unbranded versions of patented medicines.
The Commission's declaration at the World Trade Organization (WTO) in the first week of March that the seizures by Dutch customs authorities were justified by their objective to combat counterfeit medicines illustrates the confusion between illegal counterfeit medicines and legitimate generic medicines in transit in the EU.
The Parliament's position, as reflected in its 2007 resolution, calls on the Commission to respect its international commitments to the pro-development and pro-access to medicine agenda of the 2001 WTO Doha declaration, which states that “EU policy should aim at maximising the availability of pharmaceutical products at affordable prices in the developing world”.
For the sake of patients in developing countries – such as the 300,000 hypertension sufferers in Brazil who were to be treated with the detained medicines – we urge the Commission to amend EU customs legislation and end the detention, seizure and destruction of legitimate generic medicines in transit through the EU.
To fail to do so will result in the needless death and continued suffering of those most in need of access to safe, inexpensive and efficacious medicines.
As MEPs on the European Parliament's international trade committee, we are deeply worried that three consignments of Indian-manufactured generic medicines – seized last year while in transit in the EU – have been earmarked for destruction by EU authorities.
These consignments – of clopidogrel, rivastigmine and olanzapine – were being exported from India to other developing countries to treat patients with serious and life-threatening conditions such as heart attacks, strokes, Alzheimer's disease, Parkinson's disease and psychosis. Yet they were seized by Dutch customs authorities on the basis of alleged patent infringement.
Although these medicines are not under patent in India or in the destination countries, EU customs legislation still permits the destruction of these life-saving medicines. A humanitarian organisation, Médecins Sans Frontières (MSF), has highlighted several other recent cases of generic medicines in transit in the EU that have been detained, seized or destroyed. As MSF itself provides generic medicines to developing countries via its EU logistical bases, such actions may have a serious impact on its work.
We believe that at the root of the current wave of seizures is the blurring of the definition between legitimate generic medicines and illegal counterfeit medicines.
We entirely accept the European Commission's view that the EU needs an effective anti-counterfeiting policy and we fully support the important work of national customs authorities in preventing the illegal trade in counterfeit medicines.
It is vital to differentiate between illegal counterfeit medicines – which the World Health Organization defines as medicines having a false representation of identity and/or source – and legitimate generic medicines, which are, in most cases, simply unbranded versions of patented medicines.
The Commission's declaration at the World Trade Organization (WTO) in the first week of March that the seizures by Dutch customs authorities were justified by their objective to combat counterfeit medicines illustrates the confusion between illegal counterfeit medicines and legitimate generic medicines in transit in the EU.
The Parliament's position, as reflected in its 2007 resolution, calls on the Commission to respect its international commitments to the pro-development and pro-access to medicine agenda of the 2001 WTO Doha declaration, which states that “EU policy should aim at maximising the availability of pharmaceutical products at affordable prices in the developing world”.
For the sake of patients in developing countries – such as the 300,000 hypertension sufferers in Brazil who were to be treated with the detained medicines – we urge the Commission to amend EU customs legislation and end the detention, seizure and destruction of legitimate generic medicines in transit through the EU.
To fail to do so will result in the needless death and continued suffering of those most in need of access to safe, inexpensive and efficacious medicines.
