Doubt over drug registration deadline

Date: 27/02/1997

By Simon Coss

MAKERS of cut-price 'generic' medicines claim the European Commission is not doing enough to ensure they will be able to market their products across the Union when new drug approval rules come into force at the beginning of next year.

There are currently 15 different procedures within the EU for registering generic drugs. This means the same product is often sold for varying uses in different countries.

Under existing rules, a drug licensed for use both as a painkiller and as a treatment for low blood pressure in Spain, for example, might only be sold as a painkiller in France or to treat blood pressure conditions in Germany.

On 1 January 1998, member states are supposed to switch to a 'mutual recognition' system for registering generics, so that approval in one member state means approval in all.

The European Generic medicines Association (EGA) says that, as things stand, there is little sign that member states will be fully prepared for the change-over by the new year deadline.

“From January 1998, it will no longer be possible to register generic medicines under national systems and the mutual recognition procedure will be compulsory. Many people are worried that it will not be possible to solve all the problems encountered under this procedure in time and that the generics industry, which accounts for an increasing number of jobs in the European pharmaceutical sector, will suffer the consequences,” said EGA Director Greg Perry.

Perry argues that the Commission's Directorate-General for industry (DGIII) is not doing enough to ensure the switch to mutual recognition goes ahead as planned, adding: “I cannot believe the European Commission would allow this situation to continue much longer.”

DGIII officials admit the change-over is not going as smoothly as they had hoped, but insist the target will be met. They point out that Industry Commissioner Martin Bangemann has already confirmed there will be no change to the 1 January deadline and claim they have the legal instruments to push the changes through if necessary.

But they say it is unfortunate that a massive 97&percent; of drug manufacturers have chosen not to take part in a voluntary mutual recognition scheme which has been running since the beginning of 1995.

“We are disappointed that the number of companies which have chosen mutual recognition during the trial period is so low, but we will have the system in place and functioning on time,” said an official.

One of the problems faced by makers of generic medicines is that they have to follow the lead set by the big drug firms which design and patent new products. Those firms are currently showing little inclination to follow the mutual recognition route.

“There is an arbitration procedure available to sort out disagreements over approval between the member states, but the big drug companies tend not to use it. They will simply not introduce their products in 'difficult' states,” explained one expert.

This means that when the generic companies move in to make cut-price copies of a drug whose patent has lapsed, they are faced with the problem of trying to copy 15 different 'originals'.

“The irony is that unless a solution to the current situation is found, the mutual recognition procedure will actually restrict trade, not encourage it,” warned Perry.