Symposium closes by considering Pharmaceutical Package Reforms

Dr. Martin Terberger co-chaired the final session of the 2008 TOPRA Annual Symposium by looking ahead to the future for Medicines in Europe. The key feature of this over the next few years will be around the proposals contained in the Pharmaceutical Package to be released later this month. The Package will have a communication by the Commission as well as legal proposals in three essential areas:

• Safety of the supply chain,
• Information to patients; and
• Pharmacovigilance.

This will help to address the new challenges, such as globalisation, that the industry and the European Medicines Regulatory Network (EMRN) face in the near future.
The Commission will put forward a proposal to give the European Medicines Agency the power to require a specific product ID. So dangerous are the threats posed by counterfeit medicines, that the Commission believes that the time for action is now. Stefan Fuhring of the Commission said that the challenge is twofold—maintaining the single market while responding to the global environment in which drugs are manufactured.

The changes to provision of patient information are aimed at improving access to medicines in Member States, particularly those that are smaller or have reducing purchasing power relative to the larger, richer Member States. These will scale back some of the local language requirements that firms find costly.

In the area of pharmacovigilence, the package will introduce measures aimed at strengthening transparency, monitoring literature, and simplifying reporting.

Dr. Terberger said that while the Package addresses some important issues that were not able to be included in the 2005 Medicines Legislation, some issues remain. He suggested that the major forthcoming evaluation of the EMEA by the Commission would provide additional scope for considering further changes to the current system.

In closing, he asked the delegates to see the medicines policy as a whole.

New TOPRA President Alan Hunter said,

‘We really appreciated Dr. Terberger’s perspective. We anticipate the package and will work on a meeting to address the issues in Brussels in February 2009 with the Commission’s support.’

Hunter went on to say,
‘This has been a fantastic Symposium. The feedback we have received is that delegates have found that it exceeded their expectations. It’s clear that there is a lot of change in the industry right now and every regulatory and pharmaceutical professional needs to keep up with these fast-moving developments. TOPRA is the best place for them to do that. Our Budapest Symposium is a prime example of that.’

TOPRA would also like to thank the National Institute of Pharmacy in Hungary for co-hosting the meeting.