There has been a lengthy debate about the contents of the directive in the European Parliament and the Council of Ministers, and it has become apparent that the implementation of the directive could be as difficult as its approval. Differences over some of the final details of the legislation could mean that it will not come into full operation for at least a few years because there are still disagreements over how the GMP standards on APIs should be embodied in the directive.
FMD is scheduled to come into effect this month, Jan. 2013; however, the European Commission (EC), the Brussels-based EU executive, is still in the early stages of deciding on the legal status of GMP guidelines in relation to the legislation. Some EU member states are also being slow in incorporating the directive into national legislation. For example, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) was scheduled to complete, only by Nov. 19, 2012, a consultation exercise with stakeholders on how to transpose the FMD into national law. "We are working hard to make sure deadlines are met," says an MRHA official. Furthermore, groups like European producers of APIs, whose grievances about low-quality imports have helped trigger the drafting of the directive, are still complaining that the FMD is not tough enough on GMP standards for non-EU APIs.The primary intention behind the directive is to establish a secure pharmaceutical supply chain with rules stipulating quality requirements extending from starting materials to the distribution and packaging of medicines. European manufacturers of generic medicines have, however, warned that the legislation's aim to cover both counterfeit and substandard products could push up the cost of low-priced, off-patent pharmaceuticals at a time when European governments with austerity budgets are trying to reduce healthcare costs. Because of the range of the FMD, the EC has been given the power to draw up "delegated acts" or additions to the legislation that do not have to be approved by EU legislature, but have to be adopted by member countries without any changes. These extra details cover areas such as Internet marketing and security features on medicines packaging, on which the EC has been issuing drafts in the form of concept papers for consultation.
A key area to be covered by a delegated act is GMP rules on active ingredients. A concept paper on proposals on principles and guidelines on GMP for active substances has completed its consultation process. At the moment, the drawing up of a delegated act on the guidelines is being handled by an expert group, in which all member states are represented. "The delegated act will be adopted and published by the Commission in 2013," an EC spokesperson said.
The paper's main suggestion is that a 2003 directive that gave legal backing to GMP guidelines on finished medicinal products should be extended to cover the EU GMP guidelines on active substances. "This approach would bring coherence in terms of the regulatory setting for both medicinal products and active substances," the EC said. "The principles and guidelines for GMP would (as a result) be the same during the manufacturing of active substances as well as medicinal products."
There are, nonetheless, parts of the 2003 legislation that would not apply to the GMP guidelines on active substances; for example, marketing authorization for the manufacturing of pharmaceuticals and responsibility for ensuring adherence to GMP standards being allocated to a specific "qualified person" within a drug company.
The EC has proposed that the active substance guidelines would not only apply to APIs, but also to starting materials with an obligation placed on API manufacturers to ascertain that these materials are sourced from premises claimed by the supplier. In addition, the EC suggested that the delegated act on the guidelines would have to be transposed into national legislation within six months of publication so that it can be enforced within nine months.