BRUSSELS, Belgium - The European biotechnology association, Europabio, has promised to back the draft regulation to promote orphan drugs, which started its legislative journey at the end of July.

Anthony Arke, secretary general of Europabio, said in a prepared statement, “We will work closely with the European Commission and the European Parliament in making this legislation effective and beneficial both to patients, whose lives will be saved, and to the development of the biotechnology industry.“

Arke expanded on Europabio's early welcome for the proposal. “A European orphan drug regulation will be timely,“ he said. But he also was conscious of the need for the new rule to be backed not only by industry, but also by national governments in the European Union (EU). One of the recurrent problems with EU rules is that they are not always respected at the national level, even when they are formally adopted by the EU.

“If properly implemented in the legislation of the member states, it will be an important incentive for investment in research and development of products for treatment of rare diseases,“ Arke said.

Europabio also is stressing the industrial benefits of the new rule. “Furthermore, it will foster the creation of small and medium-sized biotech enterprises in the European Union, as it did in a similar way in the 1980s in the United States,“ Arke said.

Bioentrepreneurship “is essential to the health and growth of the European economy,“ he added. - Peter O'Donnell