Landmark vote on pharma package could go ‘either way’

Date: 17/10/02

By Karen Carstens

THE European Parliament is set to vote in a first reading on a massive overhaul of EU-wide pharmaceuticals law on Tuesday (22 October) which will determine the shape of the market for the next decade or more.

Industry figures all agree that this is a landmark moment for the sector.

'It's very important to get this package right for all parties involved,' said Brian Ager, director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA). 'Getting it wrong will probably decrease European competitiveness further.'

Some 850 amendments have been tacked on to the pharmaceuticals package since it was first proposed by the Commission about a year ago.

Ager said EFPIA is 'by and large' satisfied with the draft pharaceuticals directive - which includes rules on veterinary medicines and a regulation on the European Agency for the Evaluation of Medicinal Products (EMEA).

However, many MEPs, as well as health, patient and consumer groups, remain concerned about how much information will in future be made publicly available on new treatments and how long corporations will be allowed to keep the ingredients of their preparations under wraps.

Medicines in Europe Forum, for instance, comprised of some 60 organisations from 10 member states, calls the set of legislative proposals 'a threat to public health'. The Paris-based collective said it put down some 100 amendments in July that were supported by some dozen MEPs.

An aide to the rapporteur on the package before Parliament, French conservative MEP Françoise Grossetête, said Tuesday's vote could go 'either way'.

Even after all the tinkering, there are rifts between MEP's from all camps on many issues, he said, with 'three or four positions' within one political group not uncommon. 'The chances of the package going through are really 50-50 at this point,' he said.

One key provision of the pharmaceuticals draft directive is the '10+1' formula that aims to harmonise patent protection for drugs' companies at ten years, plus an additional year if the product is found to have another use after it is launched. Currently, the timeframe for patent protection varies between member states.

According to Ager, '10+1' is essential for drugs companies to stimulate research. 'It's good for us and our ability to innovate, it's good for patients and it's also good for generics,' he said.

One amendment would allow generics companies access to patent data after eight years, although they could only sell the product after the full ten years, Ager said. But this would provide less incentive to develop new medicines, giving generic companies fewer drugs to copy in the longer term, he said.

A second major item relates to the registration of new medicines. Currently, there are two registration procedures available for companies seeking marketing authorisations in Europe: a centralised procedure coordinated by the London-based EMEA and a 'mutual recognition' process managed by national authorities. The

Commission has proposed a complete switch to the EMEA system, but EFPIA supports a continuation of the mixed approach.

Anne Nielson, vice president and senior counsel for Europe for the Bristol-Myers Squibb Company, said both systems should ideally be kept in place for about another decade because a sudden switch to full centralisation would be a bureaucratic nightmare.

Another contentious item in the package concerns patient access to information. The Commission has proposed making more information available on prescription medicines for the treatment of AIDS, asthma and diabetes for a trial period of five years.

But EFPIA and others claim that the limitation of information to these three disease areas is discriminatory.

'The Parliament has rejected this,' Ager said, and we welcome this 'think again' approach.

Moreover, a related proposal to widen the definition of advertising to include 'awareness of the availability of medicinal products' is a step backwards, according to EFPIA, because patients would be denied information on the medicines available for treating their diseases.

Some parliamentarians, Ager said, feel that 'this is a dangerous first step down the slippery slope of consumer direct advertising'.

But, he said, the EU industry is still light years away from US-style advertising which allows the ordering of drugs online without a prescription. 'The goal is to allow companies and advertisers to provide good, reliable information; it has nothing to do with being able to access an electronic pharmacy.'

EMEA spokesman Martin Harvey said the regulatory body has pushed for a 'fast-track' approval procedure akin to the US system. 'This is good for industry and good for patients,' he said. The bottom line, he added, is that the new regulations would allow drugs companies the freedom to innovate and operate to the best of their capacities.

'We have to help the pharmaceutical industry, because if it's not a strong industry, we don't have any new drugs,' he said.

The European Parliament is set to vote in a first reading on a massive overhaul of EU-wide pharmaceuticals law on 22 October 2002 which will determine the shape of the market for the next decade or more.