The start of the Dutch summer saw a large group of people voluntarily forsaking the long-awaited, glorious weather to enjoy a full-day workshop on novel ways of organising pharmaceutical innovation, from basic research through clinical trials, regulation, manufacture, and distribution. The workshop attracted over 80 international participants, with 30 more joining online from many corners of the world, including Argentina, India, Canada, Malaysia, Taiwan, the US – and all over Europe. Those who made it to Amsterdam included policymakers, academics, clinicians, and representatives of NGOs, patient organisations, and pharmaceutical companies, who were arranged into small groups to encourage productive discussion.
Tineke Kleinhout-Vliek (University College Dublin) and Paul Martin (iHuman, University of Sheffield) chaired the event with professional facilitation by Frank Kupper (Mens in de Maak).
After the spectacular successes of pharmaceutical innovation in the 20th century, recent decades have seen a slowing in drug discovery, increasing costs of drug development and medicines, and failure to develop and organise access to medicines for rare conditions and neglected tropical diseases. In response, initiatives in the public and non-profit sectors are developing new ways of organising the discovery, testing, regulation, manufacturing, and distribution of medicines. These exciting initiatives include public-private product development partnerships, patient and clinician-led trials and development of medicines, hospital-based manufacturing, expanded access schemes, collaborative registries to facilitate data collection and reimbursement, and publicly-financed drives for repurposing (generic) drugs for ‘new’ indications.
The workshop was built on the premise that these initiatives could be productively understood as together forming a ‘new mixed economy’ of pharmaceutical innovation in which a range of non-commercial organisations are active agents in addition to private players. These new forms of organisation do not necessarily replace the commercial pharmaceutical industry, and many exist in collaboration with the industry. Nevertheless, many use alternative organisational forms to meet unmet medical needs. The organising team posed that policy should actively support the creation of these innovative models – sometimes labelled ‘social pharmaceutical innovations’ (SPINs) – and thus actively advance this new mixed economy. The team sent around a discussion paper beforehand, outlining the developments in the field and setting out conversational themes. The paper highlighted several domains where these alternative models face challenges and asked pertinent questions.
The day itself featured several short presentations of alternative models accompanied by panel discussions that explored issues raised by participants in structured group discussions. We identified challenges facing those developing new ways of organising pharmaceutical development and manufacturing. We then imagined how we might collectively build structures to support these new models to overcome these challenges.
The overall purpose was to encourage people to crack open and reflect on long-standing and widely-held assumptions, both of the discussion paper and those held by people in the room. For instance, questions of who gets to determine priorities, unmet medical needs, and fair reimbursement/reasonable prices are always on the table. While patient organisations are often presented as having some role in answering these, we explored questions of their responsibility – and reflected on the underlying assumption that their involvement is, per definition, ‘democratic’. We thought carefully about the competing interests of stakeholders and how any ‘solution’ would involve ‘rebalancing’ those interests. Another commonly-held assumption is that ‘Big Pharma’ is required to take on a coordinating, manufacturing, or licensing role in these innovative models, and we asked whether the knowledge and expertise present in patient organisations, academia, small companies, and so on could not be better utilised. Perhaps most critically, we realised the voice and role of lower- and middle-income countries in developing novel models of organisation pharmaceutical innovation have not been given enough prominence.
With the benefit of these discussions, the workshop team is putting together a position paper for publication in a peer-reviewed journal, to which workshop participants will be invited to contribute.
On behalf of the organising team, we eagerly anticipate continuing these conversations, and we thank all participants and, in particular, our expert speakers and panellists:
- Catriona Crombie – LifeArc
- Donald Lo – European Infrastructure for Translational Medicine (EATRIS)
- Ellen Moors – Utrecht University
- Els Torreele – University College London
- Hans Waals – TioFarma
- Jon de Vlieger - Lygature
- Michael Hopkins – University of Sussex
- Roz Scourse – Médecins Sans Frontières (MSF)
- Saco de Visser – Future Affordable and Sustainable Therapies (FAST)
- Susi Geiger – University College Dublin
This workshop, held on 15 July 2024 in Amsterdam, was supported by EATRIS, The Dutch Centre for Future Affordable and Sustainable Therapies (FAST), and Lygature and sponsored by the Social Pharmaceutical Innovation (SPIN) project at the Copernicus Institute of Sustainable Development, Utrecht University; the Orphanisation project at iHuman, the University of Sheffield; and the MISFIRES project at University College Dublin.
