BioWorld International Correspondent

BRUSSELS, Belgium - Any company that feels oppressed by the flood of pharmaceutical guidelines from the European Medicines Agency now has the chance to object.

The agency launched a consultation document last week on the future of its guidelines, inviting comment before December. It says it wants to “put in place a transparent process for the development, consultation, finalization and implementation of pharmaceutical guidelines.”

The 100-plus pharmaceutical guidelines from the agency, developed over the last 20 years, provide what it claims is “essential information to be taken into account in the research and development of new medicines.” The guidelines have no legal status, as such, but they “are to be considered as a harmonized European Union position, which, if they are [followed by applicants], will facilitate assessment, approval and control” of medicines.

But industry executives have long complained that guidelines often are unnecessary and impose onerous requirements on new medicines development. They also have alleged that their views are insufficiently taken into account in the development of guidelines. The bio-pharmaceutical sector, in particular, has been critical of undue or premature regulation stifling its innovative capacity or drowning it in bureaucratic testing procedures.

The agency’s consultation document is defensive, observing that many of the guidelines are the result of the European Union’s harmonization activities with Japan, the U.S. and other international partners through conferences on human and veterinary medicines. And it argues that its guidelines on scientific issues reflect “a harmonized European Union approach” based on scientific knowledge. The need for a new guideline might “arise due to the development of new technologies, new practices, or new therapeutic areas.”

The agency recognizes that it often has been under attack for over-regulation. It says that “an important aspect of the proposals relates to how decisions are taken on whether new guidance is needed,” and proposes what it calls “a consistent and transparent approach that will include an assessment of the impact on interested parties and competent authorities.”

According to the consultation document, after drafts are put out for industry views, comments are considered and the guidelines are revised based on those deemed relevant. The consultation document sets out the normal steps in the evolution of a guideline, but points out that those might be short-circuited when the need for new or updated guidelines is urgent.

The agency has been working on the consultation document for more than a year. It is the first chance for the pharmaceutical industry to give its views. The agency intends to implement the final document in early 2005.

More European Hurdles For GM Maize

European member states’ experts failed on Monday to support a proposal by senior European Union officials to import genetically modified maize from St. Louis-based Monsanto Co. The maize has been genetically modified to resist certain insects by producing a toxin in the plant.

It is the eighth attempt in the European Commission to win support for a GM product. EU officials now must decide whether to send the Monsanto application to a vote by ministers. If there is no agreement from ministers, the officials will be entitled to make a decision themselves - as they did in May, when they approved a GM maize after member state ministers failed to reach a decision.

Before the discussion on Monday, the French Commission for Genetic Engineering had expressed concern over the results of a feeding study of the GM maize on rats, which showed significantly different levels of white blood cells, kidney weights and kidney structure, as well as lower albumin/globulin rates in the rats. And an alliance of environmental, farming and civil society organizations wrote to European Union officials in early September accusing them of “caving in” to pressure by the U.S. and the World Trade Organization to accept GM foods.

Adrian Bebb, GM campaigner for Friends of the Earth Europe, said, “The European Commission seems determined to force genetically modified foods down consumers’ throats even when there are serious questions about their long-term safety.”

Environmentalists, Regional Authorities Launch Initiative

Meanwhile, a new European campaign has emerged to protect traditional crops and products from the consequences of the introduction of new genetic technologies. During the European Parliament meeting in Strasbourg, France, on Sept. 14, the Assembly of European Regions and Friends of the Earth Europe set out their desire for a binding European legal framework on the coexistence of traditional and transgenic crops, and for legal recognition of GMO-free zones and regions in Europe.

The campaign won support from one of the new intake of Polish members of the European Parliament, Janusz Wojciechowski, who has just been elected vice president of the parliament’s agriculture committee. He said: “Poland and other new EU member states want to preserve our traditional agriculture and avoid the errors that the old EU member states made in the past.”

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