December 19th, 2011- HealthCare Regulatory update

The Physician Payment Sunshine Act (PPSA) which requires pharmaceutical and device companies to report their payments to physicians and healthcare providers may shed even more light on payments to physicians than previously expected. According to recently unveiled proposed rules by the Centers for Medicare & Medicaid Services (CMS), Drug and device companies will, in fact, be required to report payments that flow directly or indirectly through third party entities and end up in doctors’ pockets, as long as the company is aware of the identity of the doctor The regulations recently released by CMS suggest that the agency has defined their purview quite broadly, such that payments from industry to third parties, who in turn provide payments or other transfers of value to physicians or teaching hospitals must now be reported.

The trend toward greater transparency is not unique to the U.S.

France is in the process of taking a more comprehensive approach. Legislation not only considers to increase transparency but also limit pharmaceutical marketing practices more broadly vis a vis medical professionals and institutions.  This legislation is so comprehensive in scope that it brings change to the way drugs are approved in France and the use of experts to assist in regulatory decisions and the way that company sales representatives go about their jobs.

December 8th, 2011- Health Technology Assessment

Drug and device makers have just released a position paper on ‘The value of industry involvement in HTA’. The paper outlines the industry contribution to the HTA process, both in terms of inputting into the policy setting and methodology development, as well as the industry contribution in terms of specific assessments. The significant industry experience with HTA systems over time and across countries, and their invaluable knowledge of the  products developed and the data produced, is a great contribution that any HTA system should build on. A robust framework allowing for transparency and public involvement will ensure that the HTA process acts as a tool to allocate resources efficiently and therefore free up resources for continued innovation, in turn improving patients’ access and outcomes, and overall system efficiency.

http://www.efpia.eu/Content/Default.asp?PageID=559&DocID=12353

November 30th, 2011 – Research, innovation and competitiveness

Horizon 2020: Commission proposes €80 billion investment in research and innovation, to boost growth and jobs

The European Commission has today presented a package of measures to boost research, innovation and competitiveness in Europe. Commissioner Máire Geoghegan-Quinn has announced Horizon 2020, an €80 billion  programme for investment in research and innovation. Commissioner Androulla Vassiliou has put forward a Strategic Innovation Agenda for the European Institute of Innovation and Technology (EIT), which will receive €2.8 billion of funding under Horizon 2020. In parallel, Vice-President Antonio Tajani has announced a complementary new programme to boost competitiveness and innovation in SMEs, with an additional budget of €2.5 billion. The funding programmes run from 2014 to 2020.

November 30th, 2011 – Health and IT

Driving forward the uptake of e-Health with a new network for European Co-operation

Today the European Commission adopted a Decision establishing an eHealth Network, as foreseen by the Directive (2011/24/EU) on Patients' Rights in Cross-border Healthcare. For the first time, EU legislation includes provisions on eHealth with clear objectives to find modern, innovative solutions for providing better and safer healthcare for all Europeans.