BioWorld International Correspondent

BRUSSELS, Belgium - Promoting "the competitiveness and dynamism of the pharmaceutical industry - including the biotechnology sector" is at the top of the agenda of Günther Verheugen, the German who is due to take over on Nov. 1 as the European Union's chief official for industrial affairs.

His pro-industry feelings are evident in a letter he wrote to the European Parliament, which has yet to confirm his appointment as enterprise commissioner. The letter suggested a key role for the pharmaceutical sector in both public health and helping boost the EU's competitive edge.

"The sector is important as a source of high-quality jobs, an investor in research and development, and a significant positive contributor to the EU's trade balance," he wrote.

The letter also contained recognition of the difficulties the pharmaceutical industry faces, particularly the negative impact that Europe's low product prices have on research capacity. The European pharmaceutical industry's position "is being eroded, since it is losing ground to its competitors at world level," he wrote. And he made clear his intention to see the commission take a more active part in developing alternative approaches to pricing and reimbursement "aimed at promoting innovation and making it financially rewarding."

The commissioner-designate also promised renewed efforts to create a legislative framework for pediatric medicinal products and new types of treatment. "A proposal for a regulation on medicines for children will be shortly submitted," he said.

Other commissioner-designates also have visions. Janez Potocnik, the Slovenian who will be in charge of EU research policy, told the parliament he wanted a high budget allocation - some €30 billion (US$37 billion) - for the next five-year plan for research support, despite opposition from national governments wanting to keep the costs down. Boosting research ensures "steady economic growth" and "more and better jobs for European citizens," he said.

Markos Kyprianou, the Cypriot who will be in charge of health, noted the challenges from "the rise of chronic diseases, the aging population and citizens' rising expectations for health information and health care." He warned of the "serious threat" from communicable diseases, including rising rates of HIV/AIDS infection in the EU and its eastern neighbors and severe acute respiratory syndrome. He also mentioned the avian flu and the rise of drug-resistant infections in hospitals and drug-resistant strains of tuberculosis. He saw a big role for the new European Centre for Disease Prevention and Control in Stockholm, Sweden - due to open in May 2005 - which by 2007 will have a staff of 70 and an annual budget close to €29 million.

And Charlies McReevy, the Irish finance minister, who will be commissioner in charge of the internal EU market, also promised action to ease the burden on small firms. "Compliance costs and procedures often have a disproportionately negative impact on small firms, and their reduction must be a priority," he told parliament, adding that some rules need to be simplified or removed from the statute book.

Meanwhile, the European drug industry has been pressing its case for better treatment. The European Federation of Pharmaceutical Industries and Associations, under its new president, Franz Humer (also chairman and CEO of F. Hoffmann-La Roche Ltd., of Basel, Switzerland) is aiming to focus the European debate on three areas: strengthening the EU science base, speeding up patient access to innovative medicines and improving the regulatory environment.

The industry is aware of the particular sensitivities surrounding the use of genetic data in the broader European debate over research. In published defense, it said pharmacogenetics is "inherently low risk" since it is more concerned with drug response rather than diagnosis or prediction of disease. The challenges must be met, it said, by "providing procedures for regulating both drugs and associated diagnostic tests that will not delay the introduction of new drugs, avoiding over- or misinterpretation of complex genomic data, and modernizing regulatory pathways to take the greatest advantage of these new tools for drug development."

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