MEPs under pressure over child drugs

By Martin Banks

Date: 01/09/05

Health issues will feature prominently in Strasbourg next week when MEPs meet for their first parliamentary plenary session since the summer recess.

MEPs will vote on Thursday (8 September) on a European Commission proposal aimed at stimulating research into medicines for children.

The proposal aims to increase the development and authorisation of medicines for use in children and improve the available information.

It would establish a paediatric committee at the European Medicines Agency and increase safety-monitoring for children's medicines.

A controversial aspect of the regulation is a proposal to reward pharmaceutical companies for carrying out paediatric tests on drugs with a six-month extension to the length of patent protection.

The further six months of protection would, according to the Commission, provide an incentive for the pharmaceutical industry to invest more in research and development on drugs aimed at children, although some companies consider the potential return on investment in childhood diseases and medicines insufficient to justify such investment.

It is estimated that more than 50% of the medicines used to treat Europe's 100 million-strong paediatric population have not been tested and are not authorised for use in children, posing a potential threat to children's health.

Parliament's rapporteur on the issue, French EPP-ED member, Françoise Grossette, supports the Commission's proposal, including the six-month extension. Her report recommends that the regulation be reviewed six years after it enters into force.

The European Generic Medicines Association (EGA), which represents 500 EU companies, this week urged MEPs to reject any attempt to extend market protection for pharmaceuticals and support amendments that reduced the extension.

Greg Perry, EGA director-general, said that while his association welcomed the regulation, it regarded the proposed six-month period as a "disproportionate" reward for the cost of obligatory clinical trials and claimed it would add €2 billion to the EU's annual healthcare budgets.

Some member states, including Poland and Hungary, also oppose the six-month extension, preferring a variable extension ranging from three to six months depending on product sales.

MEPs will vote on Tuesday (6 September) on the optical radiation directive, which aims to protect workers from artificial and natural light.

The following day, MEPs will vote on new rules for the management of mining waste, drafted in the wake of several accidents between 1998 and 2000, including the toxic spill in Aznalcollar in Spain and a gold mine pond burst that released cyanide into the Danube, killing 1,242 tonnes of fish.

Rapporteur Jonas Sjöstedt (Swedish Left) has attempted to revive some of the amendments from the Parliament's first reading which environmentalists say are vital to reduce the risk of pollution. They object to the exclusion of some types of waste from the proposal.

The mining industry says that, in Sjöstedt's text, the financial guarantees that mining companies would have to give to cover the cost of closing a mine or for the rehabilitation of a waste facility would overlap with environmental liability law already in place.

"Companies could be required to cover the same risk more than once and the costs could be prohibitive," said Johannes Drielsma from Euromines.

Also on the Parliament's agenda are the protection of children from aspects of the internet, audio-visual policy in Europe and a debate on Turkey.