Pharmaceutical Technology Europe - September 2012 - (Page 13)

BLOGS ABRIDGED Cooperation in Global Regulation Sees Benefits Patients Wade into the European Pricing Debate Susan Haigney The European Medicines Agency says its efforts to increase interaction and cooperation with regulatory authorities in Japan have paid off. In 2007, confidentiality agreements between the EU and Japan were established for a five-year period to allow for an exchange of information to enhance regulatory and scientific processes. According to EMA, the areas of orphan drugs, paediatrics, advanced therapies, pharmacogenomics and nanomedicines have especially benefited from the collaboration. Specifically, EMA reported on an increase in the exchange of information and interaction between the two regions, including a new Japanese liaison officer and increased conference attendance. EMA stated in a release that the presence of the Japanese liaison “has provided a strong basis for mutual education, awareness of opportunities for interaction and communication between the European and Japanese authorities, helping to address publichealth issues and avoid duplication of work.” Reflector An important third party is struggling to make its voice heard in European pharma discussions. Drug pricing is not just a matter of manufacturers battling with health ministries, insist groups representing the end-users of medicines — that is, the patients. Over and above the questions of costs and bureaucracy, the more important issues of equity and patients’ rights are at stake. And these, according to patient groups, are critically threatened by delays in access to treatment. Patient associations have waded vigorously into the intense debate now starting on how to update the 20-year-old EU regimen for pricing and reimbursement. Their intervention brings an additional dimension to the concerns voiced so far about this review of fundamental EU rules — notably pharmaceutical companies’ fears that the outcome may mean tougher assessments of relative efficacy, or warnings from national health ministries that demands for faster decision-making are unrealistic. http://blog.pharmtech.com/2012/08/03/patients-wade-into-the-europeanpricing-debate/ http://blog.pharmtech.com/2012/07/16/the-potential-of-big-data/ 2 HIGH POTENCY 11 PAEDIATRICS 6 TWITTER NEWS 12 TABLET STICKING 8 CARGO SECURITY 13 BLOGS 10 OUTSOURCING 15 STAFF http://blog.pharmtech.com/2012/07/16/the-potential-of-big-data/ http://blog.pharmtech.com/2012/08/03/patients-wade-into-the-european-pricing-debate/

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - September 2012

Pharmaceutical Technology Europe - September 2012
Contents
Cover Story: Strategies for High Containment An Industry Roundtable
News Bites and Trends on Twitter
Pharmaceutical-Based Cargo Security and Theft Prevention
Outsourcing: The Macro View
Regulatory Intervention in Paediatric Medicines
Tackling Tablet Sticking
Blogs: Regulatory cooperation; European pricing; Silk protein innovation; Pharma Facebook game

Pharmaceutical Technology Europe - September 2012