Newly adopted pharmaceutical package recognises importance of pharmaceutical industry – need to ensure patient safety is key

EFPIA, the voice of the research-based pharmaceutical industry in Europe welcomes the release of the long-awaited European Commission’s ‘Pharmaceutical package’. However EFPIA urges the institutions not lose focus on the core issue of patient safety.

“The arrival of the Pharmaceutical package is welcomed and we appreciate the Commission’s recognition of the importance of the pharmaceutical sector to Europe, as well as its focus on ensuring patient safety” said Arthur J. Higgins, CEO of Bayer HealthCare and President of EFPIA. “We also recognize the benefit to EU citizens and patients of the new provisions for pharmacovigilance and improved access to health and medicines information. The industry believes that the best way to protect patients would have been a ban on repackaging of medicines. However, we will work with European Institutions to ensure that if there is repackaging of medicines, then patient safety will not be compromised.”

Director General of EFPIA, Brian Ager, added; “We are relieved that the delays to the package have now been resolved. Now the challenge is to make sure that the provisions proceed with no further delays and no dilutions to the measures proposed.”

The European Commission’s “pharmaceutical package” includes a “Communication on a renewed vision for the pharmaceutical sector” and three separate legislative proposals; on modernizing pharmacovigilance to improve the safety of medicines; on improving patient safety by reducing the infiltration of counterfeit medicines into the supply chain; and on improving patient access to high-quality health and medicines information.

The legislative proposals will now come before the European Parliament and the Council of Ministers under the EU’s co-decision procedure, where the content and detail will be debated.