BioWorld International Correspondent

BRUSSELS, Belgium - The impact of the European Union’s orphan drug rules "has far exceeded initial expectations," according to the European Medicines Agency.

More than 450 applications for orphan designation were submitted between April 2000 and April 2005, a new report from the agency said, on the first five years of the program.

More than 260 of the applications have received orphan designation, and 22 already have received marketing authorization.

"More than 1 million patients suffering from orphan diseases in the EU may potentially benefit from these new orphan medicines," the report concluded. In addition, "the legislation has stimulated industrial activity leading to company creation with promising high-tech potential."

Purely biotechnology-derived products accounted for more than one-fifth of designations in the first five years, most notably monoclonal antibodies and recombinant enzymes.

There also were numerous designations for antisense, gene therapy and cell therapy products. Overall, innovative and novel products accounted for 53 percent of designations — and "this figure is expected to further increase as more and more innovative biotech products are presented for orphan designation," the agency report predicted.

The report also revealed the scale of EU research support for these products. In 1998-2002, 47 related projects were granted €64 million ($76 million) under EU research programs — including 10 under a "cell factory" section, which received €16 million. And in 2002-2004, 27 projects in biotechnology, life sciences and the human genome received support of €96 million.

The report recorded a positive impact on the industry itself: A significant number of start-ups have been created, many existing companies have begun research on rare diseases, jobs related to orphan medicines have increased faster than general industry trends and R&D expenditure on rare diseases has grown faster than general medicinal R&D investment.

It also recognized repeated complaints by the biotech industry about national pricing and reimbursement barriers to rapid launch. EU incentives "need to be translated into rapid access of patients to the new products throughout the entire community," the report said, and experience "was not entirely satisfactory," because of delays.

EU Says Crop Coexistence Feasible

The acute sensitivities of European environmentalists over possible GM-contamination of non-GM crops may be exaggerated, the European Union suggested Friday. A new report from its Joint Research Centre on coexistence of GM and non-GM crops and seeds concluded that crop production at the 0.9 percent threshold set by the EU is feasible, with few or no changes in agricultural practices, if adventitious GM presence in seeds does not exceed 0.5 percent.

For maize, additional measures are needed for some fields particularly affected by cross-pollination due to their shape, size and relative position with respect to winds and neighboring GM fields.

The report looked in detail into the effectiveness and feasibility of such measures, for example the introduction of isolation distances between GM and non-GM fields; sowing a non-GM maize buffer strip around GM fields; and using GM varieties with different flowering dates compared to non-GM varieties.

EuropaBio Defends Romanian GMOs

A Romanian government ban on cultivation of transgenic soybeans starting Jan. 1, 2007, is being contested by the European biotech industry. EuropaBio, the main European Union lobby organization, has urged the government "to consider the benefits to Romanian farmers and agriculture ahead of hasty decisions."

Transgenic soybeans conferring resistance to a popular herbicide have EU approval for use in food and feed, but the product is awaiting EU approval for cultivation.

However, in Romania, which is still negotiating its accession to the EU, farmers have been growing those crops for five years, benefiting from increased yields and better margins. In 2005, tens of thousands of hectares of GM soybeans were grown in Romania, a large part of which was exported to the European Union for use in animal feed.

EuropaBio wants Romania to explore the possibilities for allowing farmers continued access to that technology, so they can continue to compete with Brazilian, Canadian and U.S. supplies of GM soybean to the EU.

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