Europe should have a single system for making drugs available to people who need them before they have completed phase III trials, according to European treatment activists, and European Commission officials are now signalling willingness to consider a move which could make drugs available even earlier in Europe than in the USA.
The European AIDS Treatment Group, representing treatment activists in Europe, and the Committee for Proprietary Medicinal Products of the European Medicines Evaluation Agency, met in December to discuss growing dissatisfaction amongst treatment activists and clinicians over `compassionate access' to experimental drugs. The issue has become increasingly controversial since Abbott Laboratories was forced to provide access to its new protease inhibitor in France without parallel access in other European countries.
"The difficulties we are facing entering 2000 is that despite encouraging trial results, the industry does not have enough product to fill the needs of patients" explained Simon Collins of the European AIDS Treatment Group. "As long as industry waits for phase III results to be out before deciding to increase production, we will always face a situation where a few hundred people will be enrolled in US early access programmes through a Treatment IND status granted by the FDA, and Europeans will have to wait years after."
A possible solution proposed by Ariel North of the European Commission is for the EMEA to consider granting conditional approval after the completion of phase II studies. The European AIDS Treatment Group says that such a move would end the inequalities in access that exist in Europe.
"Any pharmaceutical company that wishes to make a new product available to patients who have exhausted all other anti-HIV products has to deal with fifteen different sets of regulations" said Nikos Dedes, a Greek member of the European AIDS Treatment Group. "This results in extra delays and forces people to travel to other states where they can purchase the new product or pay very expensive and sometimes illegal parallel import fees. In some countries, such programmes are so difficult to put in place that they never happen."
Even after a drug is licensed, delays may still occur in some countries before people can get access to the drug.
"During the pricing negotiations [in some European countries] that follow approval, the newly approved product is still not on the market and such negotiations can last more than the 90 legal days [permitted by the European Commission]" explains Nikos Dedes.
The Chairman of the CPMP, Prof. Jean-Michel Alexandre, has signalled that the EMEA is willing to look at ways of speeding access.
"The CPMP is capable and ready to do a lot in this area, and on the national level we can do everything except supply drug" he said after the December meeting with the EATG. A further meeting will take place between activists and the European regulatory agency in Spring 2000 to look at potential solutions.