EC PROPOSES REGULATION TO PROMPT DEVELOPMENT OF PEDIATRIC DRUGS

European lawmakers are attempting to encourage pharmaceutical companies to ramp up the development of pediatric drugs through new patent exclusivity provisions, a European drug policy expert says.

Until now, Europe has done very little to provide incentives for the development of pediatric drugs, said Richard Kingham, an attorney with the Washington, D.C., firm Covington & Burling. But the European Commission (EC) is seeking to remedy this issue by proposing patent exclusivity extensions. These extensions will create an incentive for developing pediatric drugs that otherwise wouldn't be there, he added.

The proposed regulation would provide companies with a six-month patent exclusivity extension of all indications for an existing drug that is later approved for pediatric use. Companies could also receive a 10-year exclusion from generic competition for the pediatric version of a drug. Furthermore, manufacturers could receive additional two-year market exclusion for drugs used to treat the rarest diseases, known as "orphan drugs."

These proposals are "strategically very important" for manufacturers looking to get into the pediatric drug market due to the profits gained from additional exclusivity, said Kingham. For example, when the U.S. implemented pediatric exclusivity language in 1997, it resulted in billions of dollars of additional sales, he said.

The vote is expected between the end of 2006 and the beginning of 2007, Kingham said. He noted there seems to be little, if any, opposition to the regulation. The draft regulation is available at: http://europa.eu.int/eur-lex/lex/LexUriServ/site/en/com/2005/com2005_0577en01.pdf (http://europa.eu.int/eur-lex/lex/LexUriServ/site/en/com/2005/com2005_0577en01.pdf)