Out-Law News 5 min. read

EU pharma strategy has patients and collaboration at its heart

Pill in gloved hand

Plans to cut the time it takes to gain regulatory approval for medicines and medical devices, and drive the development of new antibiotics and other products for treating rare diseases, have been outlined in a wide-ranging new pharmaceutical strategy for Europe.

The strategy, developed by the European Commission, is patient-focused and seeks to build on the collaborative efforts of industry seen during the coronavirus crisis, said experts in life sciences at Pinsent Masons, the law firm behind Out-Law. The Commission hopes to deliver the strategy over a number of years.

Catherine Drew of Pinsent Masons said: "The strategy has patients at the heart and it recognises the need to ensure prompt access to high quality safe and effective medicines. In so doing the strategy recognises the value that both innovative and generic and biosimilar products bring to helping achieve that patient centric goal."

Nicole Jadeja, also of Pinsent Masons, said: "Importantly, the strategy recognises the power and future role for health data and data infrastructures, the need for diverse sources of funding to support innovation, the role of new medicines and alternative uses for existing ones, the need for new business models as advanced therapy medicinal products and cell and gene therapies offer the potential of one-time treatments, and the need for the innovation for environmentally sustainable pharmaceuticals and manufacturing."

The strategy pursues a number of aims, notably to ensure the quality and safety of medicines, foster patient access to innovative and affordable medicines, and support the competitiveness and innovative capacity of the EU’s pharmaceutical industry. Other aims of the strategy are to develop the EU open strategic autonomy and ensure robust supply chains including in times of crisis, and ensure a strong EU voice on the global stage.

Helen Cline of Pinsent Masons said the success of the strategy "will depend on the commitment, collaboration and contribution of all stakeholders and a focus on putting aside differences to deliver a shared vision of a Europe where patients are assured of timely access to safe, effective and affordable medicines". She said the Covid-19 pandemic "has demonstrated what can be achieved when there is a meeting of minds".

In its paper, the Commission promised to revise pharmaceuticals legislation to support the digital transformation of health care. This will include enabling "new methods of evidence generation and assessment, such as analysis of big and real world data to support the development, authorisation and use of medicines". Further plans to expand genome data research, harness the power of high performance computers and artificial intelligence (AI), and support the transition towards a world of personalised medicine were also outlined.

The Commission also identified the need for closer working together between businesses, regulators and others across the product life cycle.

Drew said: "Collaboration is a core theme throughout the strategy, drawing on the successes seen during the Covid pandemic. Proposals range from collaboration at the R&D stage between regulators, healthcare professionals and patient organisations focussing on unmet patient needs; to collaboration at the procurement stage between those running procurement processes and those focused on health technology assessments (HTAs) to ensure that evidence based decisions ensure patient access in a timely manner."

"It is clear that each proposed collaboration involves numerous parties and it will be interesting to see whether the strategy can deliver and encourage all the different organisations to work towards the same ultimate goal in a timely fashion," she said.

Marc Holtorf

Marc L. Holtorf

Rechtsanwalt, Partner, Head of German Life Sciences

The limited and poorly coordinated options to use health data throughout the EU for R&D are detrimental to both patients and the industry

The pharma strategy was one of a number of major publications issued by the Commission on Wednesday. The proposed new Regulation on Data Governance is intended as an underlying framework for further data-related reforms that the Commission set out in its data strategy, which was issued alongside a broader digital strategy in February this year. Envisaged in the Commission's data-related plans are common European data spaces in nine specified sectors, including health.

Marc L. Holtorf of Pinsent Masons, said collaboration in the sharing of health data is one of the central areas of focus of the Commission.

"A core element of the proposal is the envisaged push to create a European health data space," Holtorf said. "The limited and poorly coordinated options to use health data throughout the EU for R&D are detrimental to both patients and the industry. It is about time to change this situation fundamentally."

The challenge of how best to strike a balance between free competition and incentivising investment in the pharmaceuticals market was also addressed in the Commission's pharma strategy paper.

As the strategy recognises, breaking silos and collaboration between the many stakeholders is vital

Jadeja said: "The strategy identifies many of the challenges and opportunities faced by the life sciences sector, especially around finding effective and equitable mechanisms and models to incentivise innovation in areas like those of unmet medical need. These challenges and opportunities are not new, nor is the need to look at how we best incentivise innovation, but as the strategy acknowledges the Covid-19 pandemic has brought many of the issues into the spotlight. I hope this strategy leads to an open debate looking at incentives in the round. As the strategy recognises, breaking silos and collaboration between the many stakeholders is vital."

Jules Fabre of Pinsent Masons said that, in relation to new incentives for innovation in life sciences, the Commission's separate new action plan on intellectual property (IP) is relevant.

"On IP, the strategy is in line with previous communications from the Commission and the pharma incentives review," he said. "The Commission confirms that it will continue to assess the merits of further harmonising the so-called ‘Bolar exemption’ and, as part of its IP action plan, look into options to improve the uniform application of rules on supplementary protection certificates (SPCs) – a separate evaluation of the SPC Regulation also published by the Commission found that the national administration system for SPCs 'undermines the effectiveness and efficiency of the SPC system'."

"In its new IP action plan, the Commission says that it will assess ways to address the fragmented application of the SPC Regulation and will consider the possibility of introducing a unified SPC grant mechanism and/or a unitary SPC. The Commission also calls on member states for a rapid roll out of the unitary patent package and says that it will continue to evaluate the application of the IP Rights Enforcement Directive, notably to ensure that injunctions are applied uniformly and efficiently across member states," he said.

Also relevant to incentives, particularly in relation to investment in areas of unmet medical needs, is the Commission's inception impact assessment on EU regulations concerning orphan medicines and medicines for paediatric patients which it also published on Wednesday. Orphan designated drugs, those for very rare diseases, can benefit from a 10 year period of market exclusivity, and paediatric extensions can be secured where companies have undertaken research to investigate the benefits and risks of medicines in paediatric patients, to prolong periods of exclusivity of SPCs by six months or orphan market exclusivity by two years.

The move to make use of "active substance master files" is part of a broader ambition to streamline and simplify the regulatory process

The Commission recognised both the ongoing need to incentivise innovation and the important role generic and biosimilar medicine manufacturers have within the EU pharmaceutical market. It will consider targeted policies to support generics and biosimilars, including providing for a single assessment process across EU member states for active substances used for different generic medicines. The move to make use of "active substance master files" is part of a broader ambition to streamline and simplify the regulatory process.

In light of the challenges witnessed during the Covid-19 pandemic, the Commission has also outlined plans to build more resilient supply chains for medicines and medical devices.

The Commission said it will first engage with industry and other stakeholders to gain a better understanding of the functioning of global supply chains and identify the precise causes and drivers of different potential vulnerabilities, including potential dependencies threatening the supply of critical medicines, active pharmaceutical ingredients and raw materials based on data collection and analysis. This initial stage will inform possible measures and potential policy options that might be taken forward to ensure security of supply.

In line with the Commission's wider 'European Green Deal' plans, the strategy also sets out to make pharmaceuticals manufacturing environmentally sustainable. Plans include reducing waste from unused medicines, such as through the reduction of packet sizes, and to build on existing plans in relation to the circular economy and on the sustainability of chemicals.

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