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Health & Consumers
Medicines for Europe is glad to announce the occasion of the first European Open Industry Day in Romania, which took place in Bucharest on October 31st. The objective of the day was to open up our industry’s doors to interested institutional stakeholders. This initiative has been designed together with APMGR, the Romanian generic association, and Zentiva, who hosted the initiative, to showcase the strength of Europe’s local and regional pharmaceutical excellence. “Our goal is to provide insight into the workings of pharmaceutical plants, showing the high-level standards of safety and quality of the generic, biosimilar and value-added medicines manufacturing chain and above all showing the end result of these processes – life enhancing, lifesaving medicines and products” said Sergio Napolitano, Director for Legal and External Affairs. 
For the stakeholders present, debate and discussion focused on the key challenges we currently face in terms of market and industrial sustainability and seek to explore the opportunities for further growth in the sector. This was particularly pertinent in view of the upcoming Romanian Presidency of the Council of the European Union. 
It is essential that Europe will maintain its primary role as a pharmaceutical hub for European patients by guaranteeing universal and timely access medicines. To ensure this, European generic and biosimilar medicines play a key role. IMS has calculated that between 2005 and 2015, across seven disease areas, twice as many patients have been treated without any impact on treatment costs. 
Europe cannot rely anymore on third party manufacturers, it is of great importance to introduce a comprehensive SPC manufacturing waiver which supports greater patient access to medicines. This waiver would permit pharmaceutical companies to begin manufacturing medicines for export to non-EU countries during the SPC period as well as allowing these companies to be ready to supply in Europe on day 1 after patent expiry. 
A comprehensive SPC manufacturing waiver would reduce these barriers and encourage a level playing field, both within the EU and on a global scale. Furthermore, the waiver will provide vast benefits to patients and EU healthcare services, including faster access to a more diversified medicines supply, a more cost-efficient medicines budget due to increased competition, and a guarantee of EU-quality generic and biosimilar medicines.
The continued development of local pharmaceutical manufacturing is essential to deliver results at the pan-European level – maintaining the EU’s position as a leader on the global stage.
For more information on the SPC manufacturing waiver, please visit