Choosing the best path for the Pharmaceutical Strategy
The EU Pharmaceutical Strategy represents a real opportunity for patients, innovation and the European Commission. Just as the pandemic has brought immense challenges for Europe, it has also thrown into relief some valuable lessons that we can now use to lay solid foundations in support of the Strategy’s stated aim: to improve and accelerate patients’ access to safe and affordable medicines, and to support innovation in the EU pharmaceutical industry.
In our feedback to the Commission as part of their consultation on the Strategy, we make recommendations across four areas that we believe could help to ensure that the opportunities presented by the Strategy are fully seized for patients.
1. Regulatory flexibilities and international cooperation
The European Medicines Agency (EMA) is an essential player in innovation, driving it forward without compromising safety. Regulatory advances by the EMA are key to achieving success, but only possible if the Agency is well resourced.
This will require new infrastructure technology and capabilities such as real-world data generation, e-labelling and cloud-based submissions. Essentially, this means embracing 21st Century best practice in data management—maximising flexibility and interoperability while decreasing costs, removing barriers and ensuring data security.
We hope to see the flexibilities, international regulatory cooperation and speed the EMA has shown in its efforts to accelerate the development of COVID-19 vaccines and treatments endure past the pandemic.
2. A predictable EU intellectual property (IP) framework to drive research & development
Some argue the best way to cut healthcare costs is to reduce IP protections, but the reality is that nothing in healthcare is more productive in providing new, effective treatment options. Taking one pertinent example, many of the most promising COVID-19 treatments came from molecules that exist because of IP. Robust IP protections incentivise innovation, producing breakthroughs today and bargains tomorrow.
Alzheimer’s is another example. This is a high-risk area for investment, so it relies on the certainty of strong, predictable IP incentives and rewards. This in turn enables the creation of a competitive generic marketplace once IP protections expire. An effective Alzheimer’s medicine would be transformative for those suffering from the disease and continue to deliver value for decades.
3. Faster, more equitable patient access to innovative medicines
Currently, the median time for the EMA to approve a new active substance is 423 days. That is significantly higher than the USA (243), Japan (304), and Canada and Australia (both 346). Delays in patient access to medicines could be reduced in the EU by roughly 100 days through greater use of accelerated assessments and a faster decision-making process.
Faster access can also be achieved through mandatory clinical EU Health Technology Assessment and broader use of free pricing, as done in Germany, allowing time for further assessment while giving patients immediate access.
4. Diverse, secure global supply chains
The latest data shows that nearly 80% of EU27 pharmaceutical imports come from Europe, as do more than 70% of active pharmaceutical ingredients. While the EU seeks to grow its advanced manufacturing capabilities, maintaining a global supply chain that is both secure and reliable is just as important. Flexibility in supply chains protects against shortages, and geographic diversity allows us to access the resources we need, and adjust to avoid production disruptions in the face of natural disasters or other public health emergencies.
An ambitious Pharmaceutical Strategy that addresses these areas could become the bedrock for a truly competitive and modernised European industry that better benefits long into the future. Let’s hope the moment lives up to its promise.
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