Ms Kathy Redmond said that the European Medicines Evaluation Agency (EMEA) "rarely used" a fast-track procedure to approve new cancer drugs. In contrast, the US regulatory body, the Food and Drugs Administration (FDA) had a priority review process to approve drugs within six months, on average. It is used for drugs deemed to have the greatest therapeutic benefit.
Milan-based Ms Redmond added: "Since 1997, the FDA has subjected 18 cancer drugs to this priority review process, seven of which were also approved on the basis of preliminary evidence (accelerated approval process). EMEA has a similar mechanism of approving drugs based on preliminary evidence. However, only two out of 26 cancer drugs have been approved using this provision since I995.
Reporting the results of a survey comparing approval times in Europe with those of the USA, Ms Redmond said that the quickest European approval between January 1995 and March 2002 was 301 days and the slowest 812 days - about two and a quarter years. In contrast, the FDA had an average approval time of 273 days.
Between 1995 and 1999, the EMEA rapid review procedure resulted in quick approval of 8 anti-HIV/AIDS drugs. For example, Norvir (ritonavir) was approved in just over 5 months and Kaletra (lopinavir plus ritonavir) in 9 months. High-profile treatments for non life-threatening complaints may also be approved rapidly. Viagra (sildenafil), the first oral therapy for erectile dysfuction, was approved in just over ten and a half months.
Why do HIV/AIDS drugs take precedence over cancer drugs? Ms Redmond attributes this to the far-reaching influence of the international HIV/AIDS lobby. The launch in the 80s in the USA of the AIDS Coalition to Unleash Power (ACT-UP) is said to represent the single most important development in patients' rights in the 20th Century. It was the catalyst for thousands of advocacy groups for patients with a wide range of diseases - from depression to cancer.
But the HIV/AIDS lobby is still the pacesetter in the "patient power" movement. Ms Redmond explained: "In Europe it devotes a lot of attention to working with the EMEA to speed new treatment proposals. Compare this with what happens in cancer. The EMEA has yet to take into account the opinions of patients in the review process".
The EMEA was set up in 1995 to harmonise and speed up the drug approval system across member states, and to give all EU citizens access to treatments under the same prescribing conditions at the same time.
Abstract No. 873