§ Rev. Martin SmythTo ask the Secretary of State for Health (1) what assessment her Department has carried out of research carried out in(a) the United States of America and (b) countries of the European Union into possible side-effects in switching between branded and generic anti-epileptic drugs;
(2) what research her Department has commissioned into the side-effects of switching between branded and generic anti-epileptic drugs.
§ Mr. SackvilleEvidence relating to the bioequivalence of generic and brand named anti-epileptic products is assessed at the time of licensing. Before a generic product may be licensed in the Untied Kingdom the company wishing to market the product must provide evidence to the licensing authority to show that the product is bioequivalent to the corresponding brand leader. As some anti-epileptic drugs have a narrow therapeutic margin, particular attention is paid to the issue of equivalence with these drugs during the licensing process.
The Department has not commissioned any research into this issue. As with all medicines, the safety of 218W anti-epileptic drugs on the market is monitored by the Medicines Control Agency. Relevant research concerning generic inequivalence is assessed as part of this process. Appropriate action would be taken if evidence came to light of clinically important side effects occurring on switching between branded and generic anti-epileptic drugs.