The European Commission (EC) has posted feedback it received on a new roadmap for a pharmaceutical strategy aimed at increasing timely patient access to affordable medicines. The feedback period began 16 June; a period of public consultation remains open until 15 September, with commission adoption planned for the 4th quarter of 2020.
Organizations leaving feedback generally welcomed the development of the roadmap, but many pharmaceutical manufacturers and trade associations expressed concern that innovation and global competitiveness would not be adequately boosted. The European Federation of Pharmaceutical Industries and Associations (EFPIA) left feedback critiquing the roadmap for lacking “the necessary drivers of innovation to realize its own ambition of supporting the industry in Europe to be a world leader in innovation.”
A more robust intellectual property framework is needed for the EU to be “at the forefront of pharmaceutical innovation,” said EFPIA, which also called for a strengthened research and manufacturing infrastructure. “That means developing clinical trial networks, biobanks and data banks, building a European health data space, delivering public-private collaboration mechanisms to accelerate bringing health solutions to patients and encouraging innovative manufacturing,” said the association, which also called for a stable, adaptable, fast and globally effective regulatory framework with speedier approval times.
Pharma Solutions Europe (PSE) commented that “Profit is not a dirty word, but an economic necessity for functioning economies;” the commentary cited the price moratorium that has been in place for some time in Germany.
Added PSE, “It is far more important to bring the pharmaceutical industry to the discussion table, regardless of whether they are research-based original manufacturers, generic suppliers, biotechnological original suppliers or bio-similars. They are not the opponents of the system, but the solution providers.
MedTech Europe pointed out that many important medical technologies, such as companion diagnostics, co-packaged products, and some engineered tissue/advanced therapy products, exist at the interface of medicinal products and medical devices. The association called for expertise in medical technology among regulatory bodies that oversee these hybrid or combination products.
The German Medicine Manufacturers’ Association (BAH) noted that the strains of the pandemic “have shown that, due to the contribution of the pharmaceutical industry and other players such as pharmacies, doctors, hospitals the supply of pharmaceuticals in the EU can work even in difficult situations.” The Association favored making regulatory flexibilities enacted during the pandemic permanent, citing marketing authorization procedures and good manufacturing practices topics as two areas where current relaxation should be maintained.
Dozens of individual pharmaceutical companies also filed feedback. Recurring themes were the importance of robust intellectual property (IP) protections; as Novartis’ response said, “We are concerned by any initiatives that weaken the IP incentives framework as they would undermine [research and development] investments. Today’s innovative medicines are tomorrow’s generics, available to patients for decades to come.”
In its response, GSK asked for stronger immunization systems and a more comprehensive pandemic preparedness framework to include “scalable and sustainable” funding to rapidly address therapeutics, testing, and vaccines for new pathogens. The firm also pointed out that a sustainable healthcare system can be bolstered by appropriate use of over-the-counter medication and telemedicine, and by promoting health literacy.
Several governmental agencies and regulatory authorities also responded. The European Parliament, in its response, asked for an action plan to achieve “affordable and accessible medicines for all.” The Parliament lays out a seven-step plan that begins with developing a public network for laboratories and research centers, along with a centralized European clinical trial research center. Calling for “patients over patents,” the response points out that EU countries can make sure of compulsory licenses to bring products to market at lower prices.
The French government’s response called for rapid, generalized access to new products, together with more transparency in the drug manufacturing process from start to finish. France also “wishes to open a harmonization of European regulatory practices and to promote regulatory and administrative simplification.”
The Irish Health Products Regulatory Authority (HPRA) also pointed to the need for removing “unintended barriers to needs-driven innovation” in medical device as well as pharmaceutical development. “It may be beneficial to also directly address the need to promote agile and focused activity through regulatory simplification, particularly in the area of generic medicines,” said HPRA.
The Danish Medicines Agency complimented the roadmap for recognizing challenges faced by the medical device sector as technology develops at speed. However, said the agency, “we find that the strategy could be even more focused on medical devices. One solution could be to make a similar strategy on the medical device area or alternatively combine the pharma and medical devices strategy (instead of making two separate strategies).”
The Danish Ministry of Health expressed broad support for the aims of the roadmap, recognizing the challenges inherent in striking a balance between patient affordability and access to therapeutics versus maintaining innovation and global competitiveness. In particular, the Ministry applauded the roadmap’s recognition of the importance of addressing artificial intelligence (AI) issues. The response also lays out a detailed proposed roadmap for coordinated pandemic response.
In explaining the context for the roadmap, the EC notes that the “unprecedented” nature of the coronavirus pandemic has shone a light onto the need for modernizing how the EU ensures access to medicines. The COVID-19 pandemic, says the roadmap, “clearly demonstrates the need to modernize the way the EU ensures access to medicines for its population,” demonstrating the need “to have a future-proof and crisis-proof system to ensure timely access to safe, quality and affordable medicines under all circumstances.”
In the roadmap, the EC cites such challenges as an aging population and an increasing burden of chronic diseases, as well as the many unknowns to be faced in the wake of the pandemic. The goal, said the EC, is to “build a holistic, patient-centred, forward-looking EU Pharmaceutical Strategy which covers the whole life-cycle of pharmaceutical products from scientific discovery to authorisation and patient access.”
Among the challenges identified include the rapidly changing global context; unequal access to medicines across EU member countries, as well as medicine shortages; mismatches between areas of innovation and public health needs, as well as challenges for the innovation ecosystem; technological and scientific advances that push the regulatory envelope; and inadequate means of addressing environmental considerations in pharmaceutical regulation.
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