PharmaBoardroom was delighted to attend DIA Europe 2024 in Brussels earlier this month, bringing together a veritable who’s-who of the European and global regulatory community. The politicians, regulators, payers, patient advocates, industry representatives, and service providers in attendance were treated to a three-day buffet of engaging panels and townhalls with a wide spread of topics covered.
These topics ranged from the impact of the new EU Pharma Legislation to AI integration in regulation, progress towards health technology assessment (HTA) joint assessments next year, and a new era for real-world evidence in regulatory decision making.
Stakeholders from beyond Europe’s boundaries were also present, and attendees were given an insight into the progress towards an African Medicines Agency as well as the latest updates from regulators in Japan, Latin America, the Middle East, Turkey, the UK, and the US. Stay tuned to PharmaBoardroom for more exclusive Q&As from the conference in the coming weeks, but for now enjoy three of the key talking points.
Sustainability – The Name of the Game
“Sustainability” was the key theme of the opening day’s keynote addresses and regulators have an important role to play, according to Glenn Wells, chief partnerships officer at the UK Medicines and Healthcare Products Regulatory Agency (MHRA). He posited that regulatory agencies can be “catalysts for sustainability,” noting the MHRA’s commitment to reducing its carbon footprint via using fewer solvents, less chloroform, recycling where possible, and switching packaging from polystyrene to cardboard. Given that the British Pharmacopeia is used in over 100 countries and is mentioned in legislation around the world, Wells was confident that the MHRA’s sustainability drive will have positive knock-on impacts globally.
From the industry side, Veronique Toully, global head of sustainability, corporate affairs and risks at Belgian pharma manufacturer UCB noted the importance of tackling social and environmental issues concurrently. Introducing the fact that UCB measures both value to patients and value to the planet in its 2023 annual report, Toully called for greater cross-sector stakeholder collaboration on both social and environmental topics, concluding that “sustainability is not about doing less harm, it is about doing more good, together.”
Finally, HTA needs to get on board with sustainability too. Speaking on a panel, Rabia Sucu, president of HTA International (HTAi) explained how the definition of HTA in Europe has included environmental impact since 2020, but that challenges remain to creating truly sustainable HTA. Sucu pointed to a lack of engagement with stakeholders beyond healthcare, the need for earlier engagement on sustainability issues in the drug development process, and the urgent requirement for more data to inform decision-making. She admitted that balancing patients’ needs today with the environmental impact on future generations is an ethical quandary, but suggested that through collaboration with a broad stakeholder base – including patients – positive outcomes can be generated.
EU Pharma Legislation – A ‘Once in a Generation’ Opportunity
The new EU Pharmaceutical legislation sets out ways to increase the availability, access, and affordability of medicines in Europe. At the EU Regulatory Townhall, the discussion focused on how well (or not) the new legislation might tackle these ‘AAA’ objectives, given the slow access, high level of unmet needs, high prices, and shortages currently experienced in Europe. The legislation sets out greater incentives for companies to invest, early availability for generics and biosimilars, transparency in public funding of medical development, an incentivisation of comparative clinical trial data and greater information exchange
While 41 percent of attendees were “not confident” of the reform’s ability to improve ‘AAA’ in the next ten years according to an in-the-room poll, European Medicines Agency (EMA) Chief Executive Emer Cooke was much more bullish. Cooke described the current moment as “exciting and inspiring,” noting other important reforms in the statute book including the European Health Data Space and HTA reform. She also highlighted how the COVID-19 pandemic response saw regulators doing things differently to broaden access and availability, something the EMA is now keen to build on.
Rainer Becker of the European Commission directorate-general for health and food safety was similarly upbeat. Becker noted that EU Pharma Legislation has performed very well for over 50 years and that the new legislation paves the way for a “fairer and more competitive” ecosystem. He felt that a flexible and adaptive framework with new regulatory tools, regulatory sandboxes, and the agility to accommodate AI would be a big step forward and encouraged stakeholders to have “the courage and wisdom to embrace this innovative legislation.”
Predictably, the representative of Big Pharma on the panel – Sabine Atzor, head of European regulatory policies at Roche and representing European trade body EFPIA – was rather more circumspect. Atzor did, however, note that the revision of the EU Pharma Legislation – along with EHDS, AI legislation, and device framework – represented “an unprecedented opportunity” to turn the curve of declining European R&D. She called for a “future proof” regulatory system co-created by multiple stakeholders and which fosters international collaboration, worksharing and alliance. Atzor admitted that Europe is complex, but proclaimed that Europeans have great experience of working together and finding compromises, which needs to continue.
The African Medicines Agency – From “going to happen” to “is happening”
A continent-wide medicines agency for Africa has been almost 20 years in the making but is now – finally – coming to fruition. At the Africa Townhall, there was a palpable sense of excitement among the assembled panellists around the potential of this important project.
Session Chair Martin Harvey Allchurch, the EMA’s head of international affairs, reminisced that African regulatory harmonisation had long been a topic of discussion at such gatherings, but that only recently had the discussion shifted from “going to happen” to “is happening.” 27 African Union member states have already ratified the African Medicines Agency (AMA) treaty, with three more (Tanzania, Ethiopia, and South Africa) set to do so shortly. Rwanda has been chosen to host the agency, the board of directors will be in place by Q2 2024, and a director general will be appointed by Q3.
Chimwemwe Chamdimba, head of the African Medicines Regulatory Harmonization Initiative at the African Union Development Agency described how building on pre-existing continental structures has been crucial in getting the AMA to this point. Chamdimba noted that by adopting a “stepwise” approach and starting with regional economic communities rather than attempting to bring all 55 African nations together immediately, the process has been made more “manageable.” She was also at pains to point out that the AMA will not replace national regulatory authorities, but instead focus specifically on complex molecules, mobilising capacities from across the continent to make these products available in Africa.
Already, five national regulators in Africa have attained WHO Maturity Level Three status. For Samvel Azatyan, head of the WHO’s Regulatory Convergence and Networks Team, this status is more than just a bragging LinkedIn post and means that these regulators will be a crucial part of building up the AMA’s technical expertise.
From the industry side, there are hopes that the operationalisation of the AMA will lead to a more efficient, transparent, and predictable system with streamlined processes. “AMA is a unique opportunity to enhance access to medicines in Africa at national, continental and regional level,” said Zainab Aziz of Novartis, representing global trade body IFPMA.
While there are still specifics to iron out around digital technology implementation, clinical trial regulation, and combating falsified and substandard medicines, there is clear optimism across the board about the AMA’s potential. As David Mukanga of the Bill and Melinda Gates Foundation – a key funder of the project – added, “the AMA can really be transformative in bringing a 1.3-billion-person economy together and making it more attractive for both R&D and product introduction … this is a compelling vision.”
