MHRA responds to EU counterfeiting measures
Regulatory Agency (MHRA) has issued its response to the European
Commission's proposals to tackle counterfeiting.
The response is broadly in support of the measures but does raise some issues which it deems in need of tweaking or clarification. Shaun Gallagher, director of policy at the MHRA, stated: "We would like to start by saying that we found the Commission's proposals very clearly set out and in general terms we fully support the overall aims of this initiative. We do have some detailed comments on specific aspects of the proposals." Although some of the points raised by the commission are supported unreservedly by the MHRA it does raise quite extensive concerns over a few issues. Some of these concerns centre upon the Commissions' proposal to introduce a unique seal to packaging, which coupled with a ban on repackaging would hopefully improve product integrity. Although the MHRA supports the motive behind these moves it has concerns over how it would affect the insertion of English language leaflets and labelling when products are imported from elsewhere in the EU. The response also calls for the EU to allow the repackaging of medicinal products licensed for clinical trials. Coupled to these concerns is the issue of how the EU defines the 'market authorisation holders' and 'end-users' which are allowed to open packaging. The MHRA's fear is that legitimate practitioners will be hindered unless the system is nuanced enough allow them to go about their business while still preventing counterfeiting. Concerns over the measures hindering the operating practices of healthcare professionals and proving incompatible with national policies are seams which run through the MHRA's response. Particular consternation is shown about the proposal to create a centrally accessible record to facilitate traceability of batches through the supply chain. A product would accumulate an extensive record as it was added to at each step of the supply chain. The MHRA is worried that pharmacies would have to maintain these records over a prolonged period, adding to their administrative burden. This problem would be compounded if healthcare professionals are already providing the data for a national database. If the national and EU systems are not compatible the process could require an onerous and unnecessary doubling up of information. These issues are predominately to do with how policies are implemented and in all likelihood could be resolved. An issue that may prove to be more of a sticking point is whether the whole supply chain record should be accessible to all member states. In its response the MHRA states its can see "no added value" in implementing an EU-wide system, arguing that it is a national responsibility to take action in response to counterfeiting within its borders. That covers the major themes of the MHRA's response but there are a few other minor points of concern for manufacturers. Clarification is sought on whether the mandatory notification procedure for manufacturers and importers of active substances will apply when the material is "passing through" a member state. In addition, the MHRA wants an explanation of how the procedure would be implemented when the end user is not known by the importer or manufacturer, for example with 'atypical actives' such as glycerine. How good manufacturing practice (GMP) compliance is checked by auditors for atypical actives is another point the MHRA is seeking clarification on. The full response can be found here.