BRUSSELS, Belgium -- Biotechnology business leaders in Europe and the U.S. have been establishing some common agendas over recent months to ease transatlantic trade. Their efforts are now winning the blessing of governments on both sides keen to boost two-way commerce. Just days ago, European Union (EU) foreign affairs ministers gave their explicit backing to the Transatlantic Economic Partnership Action Plan.
The biotechnology section of the plan (which covers a wide range of other trade sectors and issues) says that "given the number of bilateral issues arising in the sector of biotechnology," government and industry on both sides will commit themselves to strengthening bilateral dialogue. This will mean dealing with the difficulty that "dialogue currently takes place in several different forums, with the result that all aspects of the issue may not be covered, and no single group meets regularly to monitor the different discussions."
At present, questions of agriculture, food, medicines, ethics and industrial policy, for instance, are handled in distinct working groups or different channels. The plan's response is to establish "an overarching group" with a dual mandate. It will monitor progress of the dialogue on the various technical issues carried out in existing groups, and will take into account their potential trade effects, so as to reduce any unnecessary barriers to trade. And it vowed to try to "increase and enhance scientific and regulatory cooperation and information exchange and to promote transparency and information of consumers."
The group will not replace or duplicate any existing group, but will include participants from the existing ones, and will take into account the views of interested parties. The target date for putting this into effect is the end of 1998.
In addition, the biotechnology experts have agreed that an early step toward accelerating the regulatory process would be to encourage simultaneous applications for scientific assessments in the U.S. and in any EU member state. The possibility of a pilot project to this effect "is under consideration," and such a project could begin "as soon as an appropriate new application is in preparation by industry," according to the plan.
Other areas covered by the action plan include the environment, consumer protection, intellectual property protection, alignment of standards and regulatory requirements, and mutual recognition for health products as well as others. *