Council of Ministers Agrees its Position for Negotiation of the Pharma Package with the European Parliament

Having agreed its position on the European Commission’s proposal for new legislation governing the regulation of medicinal products, the Council of Ministers has declared that it is ready to begin negotiations with the European Parliament. The Council’s mandate for negotiations introduces several key amendments to the proposed legislation. These include a proposal that companies that produce innovative medicines be able to prevent competitors from accessing data used to develop those medicines for eight years and the right of producers of innovative medicines to benefit from one year of regulatory market protection, extendable to two years, if certain pre-defined key objectives are achieved. The Council has also proposed an addition to the Community Code on medicinal products (Directive 2001/83/EC) that would provide EU Member States with power to require marketing authorization holders for medicinal products to make the product available in sufficient quantities to cover the needs of patients in the territory.