The European Healthcare industry calls for balanced and transparent funding of the EU pharmacovigilance system
Joint press release on legislative agreement on Pharmacovigilance fees
- European Federation of Pharmaceutical Industries and Associations (EFPIA)
- European Generic medicines Association (EGA)
- European biotech industry (EuropaBio)
- Association of the European Self-Medication Industry (AESGP), and
- European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)
EFPIA, EGA, EuropaBio, AESGP and EUCOPE (the industry) support the implementation of an effective pharmacovigilance system to ensure patient safety and recognise recent efforts which have been made to ensure greater fairness, proportionality and transparency in some aspects of the proposals for the mechanism of fees to be paid to the European Medicines Agency (EMA) for these Pharmacovigilance activities[1]. Notably the industry welcomes the improvements regarding the annual fee to be paid by the Marketing Authorization Holders to the EMA.
However the industry is concerned about the increasing financial burden of regulatory costs incurred since the adoption of the pharmacovigilance package in 2010 especially in light of the annual saving for pharmaceutical industry of € 145 million that was anticipated in the 2008 Commission Impact Assessment. Procedural fees, such as for pharmacovigilance referrals, have been significantly increased compared to the 2008 Commission initial impact assessment calculations accompanying the new pharmacovigilance legislation, without open and transparent communication of calculations supporting this increase.
Furthermore, as pharmacovigilance activities are part of the general mission of the EMA and of the National Competent Authorities to ensure public health, the industry believes that their cost should have been partly covered by community funding as established in the pharmaceutical legislation.
An overall legislative revision of the EMA fees regimes in the medicinal products sector is expected in the coming year. The healthcare industry therefore calls on EU decision-makers to present annual cost breakdowns and detailed information on performance indicators for the activities covered by the fees regime. The financial overview should include the pharmacovigilance costs at the European and national levels (including national annual fees and safety related variations), in order to come to a European-wide picture.
The industry looks forward to establishing a dialogue with regulators and payers in order to ensure that the future system is firmly based on the principles of cost-effectiveness, fairness, proportionality and transparency.
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Should you have any question or comments on this joint industry position, please do not hesitate to contact either of the following industry representatives:
- EFPIA - Communications Team, communications@efpia.eu
- EGA - Maarten Van Baelen, mvanbaelen@egagenerics.com
- EuropaBio - Marie Blanchard, blanchard@europabio.org
- AESGP - Miranda Moussa, m.moussa@aesgp.eu
- EUCOPE - Oliver Sude, sude@eucope.org
[1] Following the adoption of the pharmacovigilance legislation in 2010, the Pharmacovigilance Regulation outlines the fee system, which aims at providing the necessary funding to the EMA and the National Competent Authorities in the implementation of certain pharmacovigilance activities.
PUBLISHED ON 21 FEBRUARY 2014
EFPIA appoints Liam English as Communications Director
Brussels (14 February 2014) - The European Federation of Pharmaceutical Industries and Associations (EFPIA) has today announced Liam English as its new Communications Director.
English is currently a Communications Director at pharmaceutical corporation Eli Lilly and Company, and he will take up his post on the 12th May. He has previously held senior communication roles in the BBC, UK Civil Service and the European Commission.
Speaking about the appointment, Richard Bergström, EFPIA Director General, said: “I am delighted to welcome Liam to EFPIA, who joins at a critical time of change and evolution for the industry in Europe. This year will see big changes at an EU institutional level. We will also see further progress on industry transparency commitments, and further negotiations towards better deals for transatlantic trade and investment, all of which can lead to better outcomes for patients. Continued clarity of voice of our members’ role and contribution in combatting financial and social burdens of ill-health will be key throughout this era of change.”
Speaking about his new role, Liam English said: “This is such an exciting time to be joining the team at EFPIA. The pharmaceutical industry is built on a common core purpose to make life better for individuals and communities, but this fact is sometimes overlooked or tangled in the complexities of political and policy debates. I look forward to working to safeguard a better universal understanding and appreciation of what the industry does, how it helps people, and what policy makers need to do to allow medical discovery to flourish.”
In his new role, Liam English will lead a small, dedicated team of communications professionals with responsibility for developing and implementing effective, strategic communications plans in partnership with EFPIA senior management and members. He will also be responsible for overseeing EFPIA's reputation initiatives, building the industry's role as a trusted partner in the delivery of healthcare across Europe.
About Liam English
Liam English has over 15 years’ experience working as a senior communications professional in a variety of high-profile organisations such as the BBC, European Commission, and the UK’s HM Treasury, Department of Health, and Cabinet Office. In 2011 he took on the role of Associate Communications Director for the Australia, Canada and Europe (ACE) region, at Eli Lilly and Company. In that role he developed and implemented strategic communication programmes in line with regional priorities. This included establishing LillyPadEU, the first social media blog from a pharmaceutical company to focus purely on EU policy matters. Over the past couple of years, he has also been an active member of AmChamEU’s Communications and Marketing Group and EFPIA’s Trust & Reputation Policy Committee.
For more visit: http://www.linkedin.com/pub/liam-english/27/234/217
About EFPIA
EFPIA represents the pharmaceutical industry operating in Europe. Through its direct membership of 33 national associations and 40 leading pharmaceutical companies, EFPIA provides the voice of 1,900 companies committed to researching, developing and bringing new medicines to improve health and quality of life around the world. In Europe, the pharmaceutical industry invests around 30 billion on research and development per year and directly employs 700,000 people including 116,000 in R&D.
EFPIA members are committed to delivering innovative medicines to address unmet needs of patients and reducing the burden of chronic diseases for Europe’s ageing population. EFPIA believes in close cooperation with its stakeholders to help create sustainable healthcare systems and to develop prompt responses to health threats in Europe.
For more visit: http://www.efpia.eu
Media Contact
EFPIA Communications
+32 (0) 2 626 25 55