by Gerardo Fortuna and Natasha Foote
Affordability, availability and sustainability are the main focus points of the EU’s new pharmaceutical strategy, due to be published on Wednesday (25 November).
Coming in the wake of the COVID-19 pandemic, the EU’s pharmaceutical strategy aims to “future-proof” the European healthcare sector.
The new strategy, set to be unveiled on Wednesday, is designed to improve and accelerate patients’ access to safe and affordable medicines while also supporting innovation in the EU pharmaceutical industry.
Health Commissioner Stella Kyriakides has previously described the strategy as a “cornerstone” of health policy over the next five years. It is considered a key pillar of the Commission’s vision to build a stronger health union, as President von der Leyen set out in her 2020 State of the Union speech.
It will also inform the newly proposed EU4Health Programme and align with the Horizon Europe programme for research and innovation, as well as contribute to Europe’s Beating Cancer plan.
A first part of the strategy underlines that “research priorities should be aligned to the needs of patients and health systems.”
Therefore, the whole EU system of pharmaceutical incentives should be reoriented to stimulate innovation in areas of unmet medical needs, such as neurodegenerative and rare diseases as well as pediatric cancer.
An example of unmet medical needs mentioned in the document is antimicrobial resistance (AMR), which decreases doctor’s ability to treat infectious diseases and perform routine surgery.
By 2022, the Commission will explore new types of incentives for innovative antimicrobials, as well as measures to restrict and optimise the use of antimicrobial medicines.
The review of the incentives system will include market competition considerations in order to improve access to generic and biosimilar medicines.
Generics and biosimilars provide a large number of patients with affordable treatments and allow health potential savings in costs through their positive effect on pricing competition, the document reads.
As regards drugs affordability, the strategy recognises that decisions on pricing and reimbursement of medicines are a national competence.
Nevertheless, the EU executive aims to address the lack of transparency and consensus on costing principles by engaging with EU countries through non-legislative measures such as guidelines on principles and costing methods.
The strategy also points out the issue of expenditure on medicines in hospital settings, which is incompletely reported at EU level and it is growing rapidly.
Pharmaceutical budgets account for 20-30% of hospital expenditures and are growing faster than retail spending, the document reads.
Innovative pharma industry
One of the key aims of the strategy is to support the competitiveness and innovative capacity of the EU’s pharmaceutical industry. The Commission considers this as a key driver of job creation, trade and science so that the pharma sector can “best respond to patients’ needs”.
To do so, it aims to create a “stable and flexible regulatory environment” which offers legal certainty for investment and accommodates technological trends, including “balanced and fair incentives to reward and protect innovation”.
On regulatory efficiency, the strategy proposes to revise the EU’s pharma legislation and related framework for medicines in order to simplify and streamline them.
It also sets out to adapt regulatory requirements for medicines for human use that contain or consist of genetically modified organisms (GMOs), saying these need to be “fit for purpose”. Clinical trials are currently being “hindered by the fragmentation of national requirements,” the document argues.
One important way of doing this is by ensuring access to health data through an “interlinked system that gives access to comparable and interoperable health data from across the EU,” the document says, pointing to an upcoming legislative proposal on a European health data space.
It also sets out the creation of public-private and public-public investment partnerships such as the Innovative Health Initiative, with particular attention afforded to SMEs, academia, and not-for-profit organisations as a way to support innovation.
The strategy includes a strong push for digitalisation, and artificial intelligence which the Commission considers key to improve prevention and diagnosis as well as for the discovery and development of new medicines.
“High-performance computing and artificial intelligence can help accelerate the identification of potential active substances for repurposing and reduce the high failure rates,” it says, adding that “due care” should be taken to avoid any gender, race or other bias in the data produced by artificial intelligence.
This is part of the strategy’s goal of personalising medicine, which includes a range of digital therapies as well as access to genetic data, including establishing the “secure federated access to 10 million genomes across borders,” with a view to improving disease prevention.
One of the action points in this area is to revise the pharmaceutical legislation, with a view to adapting it to these cutting-edge developments and technological transformations.
“Strategic autonomy” for manufacturing
The part concerning resilience is the most affected by the ongoing COVID-19 pandemic. It follows the mandate from the October EU summit to achieve “strategic autonomy” for the EU while preserving an open economy.
Over the last few months, the Commission pointed out the need for the EU to bring the production of medicines and pharmaceutical ingredients back to Europe in order to avoid the shortages experienced during the COVID-19 crisis.
In a bid to reduce shortages caused by over-reliance on third country production, the Commission will push “stronger obligations for supply and transparency, earlier notification of shortages and withdrawals, enhanced transparency of stocks and stronger EU coordination and mechanisms to monitor, manage and avoid shortages.”
However, in order to review the pharmaceutical legislation in this sense, the EU executive will be firstly engaged in a “structured dialogue” with the actors in the pharmaceuticals manufacturing value chain and public authorities to identify vulnerabilities in the global supply chain.
After this preparatory stage, the Commission will formulate policy options and propose actions to strengthen the continuity and security of supply in the EU, including support for the manufacturing of critical products in the EU.
The strategy will also pursue a greener and more sustainable production in line with the zero-pollution ambition of the Green Deal, particularly when it comes to addressing waste from unused medicines.
*first published in: www.euractiv.com