Latest Report from Brussels Meeting 25 Feb 09 - A renewed European Strategy for Pharmaceuticals in Europe

25th February 2009

Leading stakeholders from the European pharmaceutical industry came together today to discuss the European Commission’s legislative changes outlined in its “Pharma Package”, published 10 December 2008.

The meeting organised by TOPRA was held with the cooperation of the European Commission, attracted representatives from European and national regulatory authorities, senior strategic, policy decision makers from pharma companies as well as a broad range of media representatives.

Opening session:

Lynda Wight - TOPRA Executive Director - opened the meeting: “This is probably the first and only opportunity for senior level discussion on the complete new EU package, which represents the most significant changes in pharmaceuticals in recent times.”

Martin Terberger – Head of Pharmaceuticals Unit (F2), European Commission, DG Enterprise and Industry - set the scene for this dedicated two-day meeting on the package which includes a communications strategy and focuses on anti-counterfeiting measures, streamlining pharmacovigilence and improving patient information.

Further to all the political sensitivities around information to patients and the issues around counterfeiting, Martin expressed his delight at finally being able to talk about the “Pharma Package”. “This meeting will provide you with the opportunity to get neutral information, strategic insight for your companies to plan ahead and debate the proposals directly with us at the Commission.”

But he warned: “Those who position themselves politically before understanding the package and who make statements put us in a difficult position. We are looking at over 100 pages, and the devil is in the detail.”

Introducing and changing legislation is a long and complex process. Stephane Lebrun – Unit A3, European Commission, DG Enterprise & Industry – provided delegates with good insight into the process of regulation that the “Pharma Package” will have to go through over the next few years.

Interestingly, the three elements to the “Pharma Package” will go through the regulation process as five separate legislative proposals amending Directive 2001/83/EC and Regulation (EC) No 726/2004.

The earliest we might start to see approval is December this year or, depending on how controversial they are, they could take as long as three years.

Session One: Development, Purpose and Expected Outcomes

Martin Terberger, joint chair of the session, highlighted that the Commission’s motivation in proposing the changes comes from a desire to improve public health protection, promoting the function of the internal market and encouraging innovation in the European pharmaceutical sector.

Irene Sacristan Sanchez – Deputy Head of Pharmaceuticals Unit (F2), European Commission, DG Enterprise & Industry – outlined the commission’s communication on a vision for the pharmaceutical sector. Which aims to make further progress towards a single and sustainable market in pharmaceuticals, take on the opportunities and challenges of globalisation and to make science deliver for European patients.

Brenton James – Consultant in European Regulatory Affairs, UK – joint chair closed this session asking delegates to reflect upon the tremendous work that has been put into this and offered credit to all involved.

More information will be in your next issue of Rapporteur.

Session Two: Counterfeit Medicines

Stefan Führing - Pharmaceuticals Unit (F2), DG Enterprise & Industry, European Commission – joint chair of the session, presented the Commission’s proposal on ‘counterfeit’ medicines.
25th February 2009

The areas discussed included obligatory safety features, audit of suppliers by purchasers, enforcement abroad by competent authorities and the proposed change to Actors in the supply chain which included a positive definition of trader, certain wholesaler requirements apply (incl. record-keeping, audit) and a notification obligation.

Interesting presentations were also given by the following:
Steve Allen – Director Global Security, Pfizer
Michael Deats - Group Manager, Enforcement Group, Inspection, Enforcement and Standards Division Medicines and Healthcare products Regulatory Agency (MHRA), UK
Aline Plancon – Interpol and member of IMPACT
Susanne Keitel, EDQM (European Directorate for the Quality of Medicines and Health)
Heinz Kobelt, EAEPC (European Parallel Distributors' Association)
Ruud van Anraat - Director Public Affairs, Teva Pharmaceuticals Europe BV
Andrew Hollingsworth, Novartis OTC

It was great to see so much anti-counterfeiting activity already taking place, however questions were asked about how could these activities be more coordinated as there appeared to be overlap.

An exciting and lively Q&A session took place that included a variety of questions. There was extensive discussion around the definition of ‘counterfeit’, the question of who was going to pay for all these additional safety measures and what is the point of implementing them if there is no action to enforce the legislation already in place? This last point was agreed by a number of the panel and an excellent example cited was of Jordan’s regulatory agencies imposing fines on the government if they are not effectively controlling counterfeit drugs, as a result of which the number of incidences of counterfeiting has reduced significantly.

Alan Hunter - President of TOPRA – commented how this large panel with a wide range of backgrounds all seemed to be in agreement with the Commission’s proposal and what needs to be done. He then asked a pertinent question on why, therefore, we can’t kick start something into action now before we see a person die from counterfeit medicines and what can we do to combat this before we are prompted to take immediate action? Some food for thought from TOPRA’s President… because unfortunately fast tracking the proposal would not be possible due to the bureaucratic process and the impending changes to European Parliament and at the Commission.

Axel Wenzel - Pharma Scientific Services, Germany, TOPRA Board Member and joint chair of the session summarised by saying that law enforcement seems to be one of the most important measures that needs to be reviewed in the fight against counterfeit medicines.

The meeting will be covered in an edition of the Regulatory Rapporteur.