'Devil is in the detail' of EC pharma package

The architects of the European Commission’s much-anticipated raft of new pharmaceutical legislation have been put in a difficult position by “those who position themselves politically...before understanding the package.”

That is the view of Martin Terberger, Head of Pharmaceuticals Unit (F2) at the European Commission, who gave the first in-depth unveiling of the ‘Pharma Package’ at a meeting hosted by The Organisation for Professionals in Regulatory Affairs (TOPRA) in Brussels, Belgium, late last month.

“We are looking over 100 pages, and the devil is in the detail,” he commented.

On the topic of counterfeit medicines, Terberger noted that the EC’s efforts could be undermined if member states do not harmonise their efforts behind the risk-management approach laid out in the proposals.

Among the Commission’s proposals are the inclusion of safety features on packaging such as tamper-evident seals and product coding to help in the identification, authentication and traceability of specific products. Rather than apply these across the board, it is envisaged that they would become mandatory for certain high-risk products. The features could only be replaced under certain strict conditions - although repackaging of medicines by parallel traders would still be possible.

Pharma manufacturers are required to audit all firms manufacturing the active pharmaceutical ingredients (APIs) they use, and a register of licensed (inspected) wholesalers would be set up.

Irene Sacristan Sanchez of DG Enterprise and Industry told the meeting that the threat of medicines counterfeiting - both in the legal supply chain and illegal drug channels - was a major factor in speeding up publication of the pharma package. A rising trend in seizures of counterfeit medicines at borders led to the January 2008 decision to make a legal proposal with two main aims, she said.

One aim is to identify possible tools under the pharmaceutical legislation to block counterfeits from entering the market, while the other is to step up enforcement mechanisms.

“It appears that there is a trend toward counterfeiting life-saving as well as life-style drugs as a lucrative business for those involved in other illegal activities such as terrorism,” she told the meeting.

Members of the counterfeiting panel convened at the TOPRA meeting, including a representative from Interpol, Aline Plancon, reiterated calls for increased law enforcement and a strengthening of the penalties that can be applied to those found guilty of counterfeiting medicines.

Stefan Fuehring of the EC’s Pharmaceuticals Unit gave a comprehensive overview of the proposals, which cover three main pillars: product characteristics and good manufacturing practices (GMP); actors in the supply chain and good distribution practices (GDP); and control of active substances, particularly overcoming shortcomings in enforcement and inspections.

A separate article looking at the proposals in much more detail will be published shortly on SecuringPharma.com. 

The pharma package was adopted by the Commission on December 10 and transmitted to the Council and European Parliament for the co-decision procedure to start. The Council’s working party on pharmaceuticals has started to examine the proposals under the current Czech Presidency of the EU.