Brussels (10 February 2014) - The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the EGA – European Generic medicines Association – fully support the agreement between the pharmaceutical industry associations in Romania to put forward a constructive proposal to the Romanian Government that would improve patients’ access to medicines.

“The EGA stands ready to support further developments that will improve access to high quality medicines at affordable prices for Romanian patients”, declared Adrian van den Hoven, EGA Director General.

Richard Bergström, Director General of EFPIA said: “Romania has some of the worst health outcomes in Europe. Patients have not had access to any new medicines for the last 6 years. The agreement reached between the various parts of the pharmaceutical industry in Romania is an important step forward. It is now up to the Government to work with all stakeholders to ensure there is adequate investment in health and that patients get the medicines they need.”

EFPIA and the EGA welcome the agreement between three associations representing pharmaceutical companies in Romania - APMGR[1], ARPIM[2] and LAWG[3] - on changes to the clawback system, a realistic medicines budget and the opening of the reimbursement list. If implemented as a holistic package, these changes will foster a more sustainable healthcare system in Romania.

Specifically, all three stakeholders ask the authorities to implement the following package of measures:

1. Ensure that reference budget for the clawback computation is set at a realistic level, in line with consumption. For 2014, the quarterly reference budget must be at least RON 1.95 billion (VAT included) or RON 1.79 billion (without VAT).
2. The introduction of a differential clawback computation from January 1, 2014, based on the distribution of drugs into two groups. Thus, the contribution will be reduced for certain medicines, the computation formula considering the current pricing system for generic drugs (up to 65% of the price of the originator medicine).
3. Immediate updating of the reimbursement list to include new molecules along with the introduction of cost/volume agreements for these products sustained by a supplementary budget.

EFPIA and EGA stand ready to support the Romanian Government and local industry in reaching an agreement that secures a sustainable business environment for all and, most importantly, access to medicines for Romanian patients.   

[1] Asociatia Producatorilor de Medicamente Generice din Romania - (APMGR)

[2] Asociatia Romana a Producatorilor Internationali de Medicamente (ARPIM)

[3] Local American working group (LAWG)

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About EGA

The EGA is the official representative body of the European generic and biosimilar pharmaceutical industry, which is at the forefront of providing high-quality affordable medicines to millions of Europeans and stimulating competitiveness and innovation in the pharmaceutical sector. The EGA is Member of the EunetHTA Stakeholder Forum.

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Julie Chauvet

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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. The pharmaceutical industry invests 30 billion on research and development per year in Europe and directly employs 700,000 people including 116,000 in R&D units in Europe.

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.

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EFPIA Communications

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communications@efpia.eu

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