NEWS

Proposals to Speed Up European Drug Approval Process Questioned

John Illman

A recent study suggested that the European drug approval system takes twice as long to approve cancer drugs than does the U.S. Food and Drug Administration, adding fuel to recent criticism of the European drug approval process.

The European Commission has unveiled plans to speed up the approval process, but these are not expected to take effect until 2003—8 years after the formation of the European Medicines Evaluation Agency. The EMEA, which functions as the European counterpart to the U.S. Food and Drug Administration, was set up to harmonize and speed up drug approval across member states within the European Union and to give all EU citizens access to treatments under the same prescribing conditions at the same time.

The new EMEA proposals are designed to ensure that scientific assessment of major new medicines is "as fast if not faster" than those performed by the FDA. It plans to complete normal authorizations within 210 days and "fast-track" reviews within 150 days.

"The situation for reviewing cancer treatments was dire—and likely to remain so for years to come," said Gordon McVie, M.D., Ph.D., director general of the Cancer Research Campaign in London. An example of the slow process: The breast cancer agent Herceptin (trastuzumab) was approved in just under 4 1/2 months in the United States compared with 18 months in Europe.

McVie suggested in an editorial in the Annals of Oncology that it may take at least 2 years to get EMEA’s new proposals through the European Parliament. "That’s before we even start to see any change," he wrote.

EMEA approval is only the first hurdle in a long, bureaucratic process. New drugs also have to go through procedures in each country to set the price of the drug before going on prescription, adding further to delays facing patients.

Kathy Redmond, a Milan-based health consultant, presented a study on drug approval times at the ECCO 11 European Cancer Conference in Lisbon last month. Her study found that the EMEA rarely uses fast-track procedures to approve new cancer drugs.



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Kathy Redmond

 
"Since 1997, the FDA has subjected 18 cancer drugs to priority review, 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 1995."

Comparing the European and U.S. systems, Redmond said that the quickest European approval for cancer agents between January 1995 and March 2002 had been 301 days and the slowest 812 days. The U.S. average was 273 days. (See Stat Bite, p. 1683)

But the EMEA rapid review procedure, she added, had resulted in quick approval of 8 anti-HIV/AIDS drugs between 1995 and 1999. Norvir (ritonavir), for example, was approved in just over 5 months and Kaletra (lopinavir plus ritonavir) in 9 months.

Redmond said she believes that HIV/AIDS agents fare better than cancer drugs because of the power of the European HIV/AIDS lobby. In the 1980s, the launch of the U.S.-based AIDS Coalition to Unleash Power (ACT-UP) was said to represent the single most important development in patients’ rights in the 20th century.

"In Europe [AIDS advocacy groups] devote 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," she said.

In addition to proposals to speed up the review process, EMEA has also said it will introduce conditional marketing authorization for cases where there is "a specific and identified patient need." It also proposes to make products available on a compassionate use basis.

The new European plan is also designed to stop the drift of pharmaceutical research and development to the United States. The United States accounts for an estimated 40% of the $380 billion global pharmaceutical market and for 60% of the profits.

Keith Redpath, pharmaceutical analyst at WestLB Panmure, London, said that EMEA’s proposals do not address the issue of price controls that make Europe a less attractive market. "We still have rampant price control in Europe," he said.

Pharmaceutical companies have welcomed the EU proposals but fear that they may have little impact unless member countries agreed to ratify the decisions. Some countries have been accused of holding back on approval of products that compete with agents developed within their own countries.

"Clearly this (the proposals) will be an incredibly important advance for cancer patients if introduced into EU legislation and implemented properly," McVie said. "But what about the thousands of cancer patients across Europe who need new treatment options today? They are still facing 18-month delays for access to vital new treatments and many simply do have that 18 months to wait."



             
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