Emulating policies in the US, Europe is stepping up with new initiatives intended to close 'the pharmaceutical gap' created by its regulatory policies and a fragmented market.

Because market prospects often drive pharmaceutical research, companies neglect diseases that affect few people or that are endemic only in developing countries. This approach is particularly acute in Europe, where cumbersome regulations have discouraged pharmaceutical innovation.

Last year, the European Medicines Agency (EMEA) adopted several policies—such as accelerated, provisional and compassionate-use drug approval—that have been available for years at the US Food and Drug Administration. “There is an enormous amount happening,” says Martin Harvey, a spokesperson for the EMEA.

There is an enormous amount happening. Martin Hervey, European Medicines Agency

Since November, the EMEA has been accepting applications for drugs to treat AIDS, cancer, diabetes and neurodegenerative disorders. This list will grow longer in 2008 to include immune disorders and other infectious diseases. The advantage to pharmaceutical companies, says Harvey, is that EMEA approval allows them to market drugs throughout the European Union—with a total population of 470 million—without having to clear regulatory hurdles in each country.

But some scientists say the changes only begin to bridge the huge pharmaceutical gap, where an estimated 90% of global diseases—including rare disorders—go untreated.

In 2000, the EMEA implemented an orphan drug act; the European Commission has also supported programs on rare diseases over the years. But “in my opinion, [those schemes] are not enough,” says Alain Fischer, director of the French Institute for Rare Diseases Research. Fischer says academics will have to take greater initiative on treatments for unmet needs.

Fischer and his colleagues have launched the European Rare Disease Therapeutic Initiative in partnership with four major pharmaceutical companies. If the initiative approves a proposal, the companies will search their libraries for compounds requested in the proposal and supply them. The researchers would then negotiate further drug development with the companies.

The new initiatives fall in line with a World Health Organization report released in November that urged the European Commission to fund research on new treatments and called for greater public-private partnerships. It also urged governments to create incentives for companies to invest in neglected diseases. http://www.erditi.org