Generic medicine makers furious at exclusion from EU-US dialogue

Date: 18/09/1997

By Simon Coss

REPRESENTATIVES of Europe's generic medicines manufacturers are furious at what they see as their exclusion from key trade talks between the Union and the United States.

The European Generic Medicines Association (EGMA) says it has been battling for months to be included in the so-called Transatlantic Business Dialogue (TABD) - a European Commission-backed initiative which aims to build links between EU companies and their US counterparts.

But EGMA representative Nadene McClay claims that her requests to participate in the scheme have met with evasion and procrastination from TABD's organisers. “They have never officially said no, they just keep on giving us the run-around,” she said.

The issue came to a head in July when McClay fired off a furious letter to TABD organiser Hanns Glatz, who works for German multinational Daimler Benz, outlining a catalogue of unanswered phone calls, ambiguous messages and referrals to countless different departments. Demanding a rapid reply, McClay concluded: “Having read through some of the considerable efforts made over the past ten months to gain access to the TABD, which should have been an open and simple procedure, I am sure you will understand our loss of patience.”

At present, only representatives from drugs firms which make brand-name products are taking part in the talks and the EGMA is concerned that its voice will not be heard.

Glatz argues that the EGMA has not provided him with the necessary information which would allow it to be included in the discussions. He also suggests the organisation has shown little real interest in the TABD, having failed to participate in open meetings in Seville in November 1995 and Chicago a year later.

“It took ten months before they gave me the names of the people they wanted to participate in the talks and then they did not say what they wanted to talk about,” he complained.

The TABD coordinator admits he has since been provided with details of the issues the generic medicines manufacturers want to discuss, but argues the list is not very wide-ranging.

The basic sticking point between the two sides of the pharmaceutical industry centres on the issue of patents for drugs.

EU law - backed up by World Trade Organisation (WTO) rules - forbids makers of generic medicines from beginning preparatory trials for the manufacture of a drug until its patent has lapsed. This, in effect, can prolong the original product's patent for up to three years.

In the US, however, it is possible to begin advance trials as long as the generic drug does not go on sale until after the original product's patent expires.

Glatz suggests one of the reasons the EGMA could be experiencing problems is that that the brand-name manufacturers simply do not want to talk to them.

He argues the generics sector would have more success if it tried to set up EU-US links with its counterparts rather than insisting on talks covering the pharmaceutical industry as a whole.

“They are standing sulking in the corner and are unhappy that the rest of the industry does not accept their demands,” he said.

But McClay insists that what is really at stake is a simple point of principle. She says that if the industry she represents wants to take part in the talks, it should not be prevented from doing so.

“It is shocking that this sort of thing should go on in what ought to be an open process,” she protested.