EU's REACH threatens drug access, says AstraZeneca

A representative of Anglo-Swedish drug major AstraZeneca has warned of the perverse effects of new European Union regulations that come into effect in April next year. David Vosvenieks, REACH issue manager at AstraZeneca, told the Chemistry & Industry magazine that two of the drugmaker's raw materials suppliers have already warned they may no longer be able to supply components for anticancer drugs.

The REACH regulations mean that many chemicals in everyday use will have to be tested from scratch, including when a drug firm changes suppliers. The new rules have come under sustained opposition over the past two years from chemical firms. Although active pharmaceutical ingredients are mostly exempt from the REACH rules, many of the other components, such as solvents and intermediates are not.

According to the UK's Medicines and Healthcare products Regulatory Authority, it could take two months to obtain approval for an evaluation each time a firm changes supplier.