Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 25 November 2020 | By Kari Oakes
The European Commission (EC) has adopted its pharmaceutical strategy for Europe. The announcement follows a period of consultation earlier this year and meets the EC’s goal of finalizing the strategy by year’s end.
The strategy is not focused on the COVID-19 pandemic, but strategies and considerations included in the document were informed by the impact of the novel coronavirus in Europe and globally.
The primary objectives of the strategy fall into four categories. The first is centered on ensuring that patients have access to affordable medicines and that unmet medical needs are addressed. Particular areas of focus are antimicrobial resistance, cancers and rare diseases.
Another objective looks at how the European Union’s (EU’s) Pharmaceutical industry can maintain competitiveness while achieving innovation. However, The EC recognizes that sustainability is also of key importance, so this goal prioritizes developing “high quality, safe, effective and greener medicines.”
The third objective is to bolster crisis preparedness and the ability to respond to crises, including supply and supply chain security. Finally, the strategy seeks to ensure “a strong EU voice in the world, by promoting a high level of quality, efficacy and safety standards.” (RELATED: European Commission consults on roadmap to pharmaceutical reforms, Regulatory Focus 02 June 2020)
“With our pharmaceutical strategy for Europe, we are delivering on our commitment to create a future-proof and patient-centered pharmaceutical environment in which the EU industry can innovate, flourish and continue to be a global leader,” said Stella Kyriakides, the EC’s commissioner for health and food safety, in a press release announcing the new strategy.
Several legislative and non-legislative actions are mapped out in the strategy. On the legislative side, EC plans to revise pharmaceutical legislation by 2022 “with a view to making this framework future-proof and innovation friendly.” Regulation of pediatric medicines and rare disease therapies will also receive an overhaul.
By the second half of 2021, EC aims to have a proposal for a health emergency response authority for the EU.
Specific aims that boost digital infrastructure and support research and innovation within the pharmaceutical sector are also part of the strategy.
At the global level, the EC seeks more dialogue between manufacturers and authorities to address global supply chain issues. Continued cooperation with other national authorities on “pricing, payment and procurement policies” is also on the map.
The EC is also revamping how the EU addresses intellectual property (IP), in order to bolster and modernize its framework. In a document released on 25 November, the EC is aiming to reduce fragmentation in the IP system and increase the use of IP protection by researchers, many of whom still underutilize available protections.
The EC also aims to develop more tool to facilitate access to IP, and to work harder to quash piracy and counterfeiting by leveraging digital measures. A “lack of fair play at global level” continues to hinder EU’s ability to compete outside its borders, said the EC, so it must combat bad-faith IP registrations and other malfeasance seen in some foreign jurisdictions.
However, the EC’s strategy for IP still recommends that member state have fast-track procedures to issue compulsory licenses, which grant authority to use a patented invention without permission of the patent holder, “as a means of last resort and a safety net.” In practical terms for pharmaceutical companies, this means that EU state could produce generic drugs in times of emergency, with or without the patent holders’ consent, “when all other efforts to make IP available have failed.”
In the press release, the EC’s president, Ursula von der Leyen, said, “The coronavirus pandemic has highlighted the vital need to strengthen our health systems. This includes access to safe, effective and high-quality medicines at an affordable price. In the challenging economic and social times the EU is currently facing, the strategy adopted today will ensure that Europe and Europeans will continue to benefit from such medicines. I call on Member States and the Parliament to endorse this approach which will be rolled out in the next three years, and beyond.”
EC pharma strategy
Tags: EU, pharmaceutical