Experts are calling for more regulatory action to bring precision medicine to the market, as big data enables more personalised treatments and prevention
Experts in personalised medicine have set out a map for what is needed to bring more data-enabled, tailor-made prevention and treatment options to patients in the EU, calling for action on regulatory oversight; the setting up of digital infrastructure for data sharing and modelling; and moves to ensure public trust.
The experts were speaking on Tuesday at a conference in Stockholm on ‘Life Sciences: The era of personalised medicine’ organised by the Swedish presidency of the EU Council in its last week in the chair.
Speakers stressed the need to rethink how personalised medicines are regulated and how clinical trials are designed, to adapt to a new reality and ensure there is trust in algorithm-powered prevention and treatment methods.
For Björn Erikson, director general of the Swedish Medical Products Agency, this new kind of medicine requires new kinds of clinical trials. “This means we really need to develop the science behind the risk benefit assessment, and that means the science behind methodologies,” he said.
Similarly, Johan Modin, director general of the Swedish Ethical Review Authority, said regulatory processes must reoriented to build trust in the technologies behind personalised medicine, alongside work with patients’ organisations to ensure their views are factored into the development of these new types of therapies.
Personalised medicine relies on having access to disparate data sources, noted Gunilla Nordlöf, director general of the Swedish eHealth Agency. Data sharing must be enabled with the help of effective legislation, technology, interoperability and citizens’ trust, she said.
Darja Isaksson, director general of Vinnova the Swedish innovation agency, highlighted the importance of putting resources into prevention, saying that €1 spent on prevention gives €6 back. “It’s crazy not to invest in it,” said Isaksson. “We need to shift investments towards more prevention, at the societal level, not just the healthcare system.”
Taking advantage of personalised medicine is one of the EU’s newer quests in healthcare policy. There’s more data than ever available on both individuals and cohorts of patients. Analysed together using algorithmic models, it can lead to optimal recommendations for each patient. But the tools to take full advantage of what the data could offer aren’t there yet.
The Commission has been working on the topic for over a decade, after holding its first conference on personalised medicine in 2011. In 2015, EU member states adopted conclusions urging action.
“It has been gaining momentum, it has been gaining interest from the policy side,” said Joanna Drake, deputy director general at the Commission’s research directorate, told the conference. “I think there is no doubt the Commission is committed to deepening the collaboration between different players and putting its money where its mouth is.”
Earlier this year, the Commission opened a €100 million call for a partnership between member states on personalised medicine aimed at filling knowledge gaps, establishing joint research systems and translating research to market.
More policy discussions on the topic are set to follow in dedicated events under the upcoming Spanish and Belgian presidencies of the EU, in the second half of 2023 and first half of 2024.