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Arian Vahidansari
| 3RD JUL 2023

Zeno Thinks: EU Pharmaceutical Reform: A Prescription for a Healthier Europe

Picture this: you're sitting at the doctor's office, hoping for a quick solution to your condition. But little do you know, behind the scenes, there's a multiplex of regulations and processes that determine whether you'll have timely access to the medicines you need. The pharmaceutical industry is at a crossroads, and as EU health ministers convene to discuss the pharmaceutical legislation revision, it's time to act. In this blog post, we'll explore the pressing need for the EU’s pharmaceutical reform and its potential impact on patient access and Europe's competitiveness in this space.

Patients are tired of waiting, and rightfully so. The current system leaves some EU citizens waiting 4.5 times longer than their neighbouring countries for access to new medicines. It's like watching a snail race while the rest of the world speeds by. Patients can't afford to wait another four to five years for the revised legislation to take effect…they need action now! That's why organizations like the European Federation of Pharmaceutical Industries and Associations (EFPIA) have stepped up to propose measures set out to improve access and ensure a more predictable and timely change.

Here's the uncomfortable truth: Europe has been losing ground in pharmaceutical innovation for the past 25 years; from being at the centre of new treatment discovery to lagging behind the U.S. and projected to be eclipsed by China in just a few years. It's Europe’s time to shake off the complacency and take bold steps to stay ahead and lead the charge in tackling these health challenges.

To address these challenges head-on, the European Commission proposes a significant reform of pharmaceutical legislation—the largest in over 20 years. The reform aims to make medicines more available, accessible, and affordable while promoting innovation and boosting the competitiveness of the EU pharmaceutical industry.

What does this mean for patients? It means ensuring timely and equitable access to safe and effective medicines for all EU citizens. The reform aims to create a single market for medicines, removing the barriers that hinder access and bridging the gap between member states. It will speed up approval processes, reduce administrative burdens, and enhance the availability of medicines, regardless of where patients live.

But it's not just about patients; the reform also addresses crucial environmental issues. It seeks to limit the negative impact of medicine production on the environment, aligning with the objectives of the European Green Deal. This may result in increased attention to sustainability and environmental messaging within healthcare communications strategies. It's a win-win situation: improved patient access and a greener future.

Finding the right balance between innovation and affordability is key. The reform proposes measures to promote innovation while ensuring affordable pricing for medicines. It introduces incentives for companies to make medicines available in all EU countries and develop products that address unmet medical needs. It also encourages earlier availability of generic and biosimilar medicines, simplifies market authorization procedures, and fosters greater transparency of public funding for medicine development.

Furthermore, the reform focuses on strengthening intellectual property rights and regulatory protection for innovative medicines. This ensures that Europe remains an attractive hub for investment and innovation, driving research and development towards the greatest patient needs.

And the real turning point here is the extension of regulatory protection for companies marketing innovative medicines. A framework that provides a minimum safeguard of eight years, comprising six years of data and two years of marketing protection. Now, you may hear the term ‘unmet need’ in the context of medicines quite often – well this is real the coup de grâce, as these medicines could potentially benefit from an additional six months of regulatory protection, and even a further year if they can treat other diseases. Topped with the ‘Regulatory Sandbox’, we are poised to see a more agile and dynamic framework for medicine authorisation.

A pharmaceutical reform is the need of the hour. It's time to dismantle the barriers that hinder patient access, boost Europe's competitiveness, and ensure a healthier future for all. And the important role of our communications industry should not be forgotten, through increased demand to raise awareness and communicate R&D advancements across Europe. With a streamlined regulatory framework, greater access to innovative medicines, and a commitment to environmental sustainability, Europe can reclaim its position as a global leader in pharmaceutical innovation.

Zeno plays a crucial role in assisting pharmaceutical companies with their communications strategies, through navigating this complex landscape by crafting clear and compelling messages that resonate with target audiences, including healthcare professionals, patients, investors, and the general public. By combining industry expertise with innovative communication approaches, we enable pharmaceutical companies to build trust, enhance brand reputation, and ultimately, contribute to better healthcare outcomes.