Good morning, health colleagues, and welcome to the first European Alliance for Personalised Medicine (EAPM) update of the week – we have news of an upcoming EAPM event in September that will take place during the ESMO Congress, writes EAPM Executive Director Denis Horgan.
‘The need for change’
The conference, EAPM’s ninth annual event, is entitled ‘The need for change – and how to make it happen: Defining the health-care ecosystem to determine value’. The event will take place on Friday, 17 September from 08h30–16h30 CET; here is the link to register and here is the link to the agenda.
High-level speakers and attendees will come from a wide range of stakeholder groups including patients, health-care professionals, academics, industry representatives, politicians and legislators, the media and more. Since the opportunity clearly exists for input into EU thinking, what input should be made in the field of cancer? The most obvious need, given the current level of fragmentation of policy and practice, is for a new degree of coherence…
But coherence is not enough. A top-down imposition of new rules cannot be the answer if the essence of the EU’s concern – the welfare of its citizens – is to have priority. The oft-cited mantra of patient-centred healthcare must also be given real meaning, and that implies a careful and thoughtful complement of bottom-up thinking too…
The sessions during the event will run as follows:
Session I: Winning Stakeholders’ Trust In Genomic Data Sharing and the use of Real World Evidence/Data
Session II: Bringing Molecular Diagnostics into health-care Systems
Session III Regulating the future – Balance of patient safety and facilitating innovation – IVDR
Session IV: ‘Saving lives through Health Data collection and usage
Top-flight speakers will include Christian Busoi MEP, Christine Chomienne, vice president, Cancer Mission Boards and Professor Sir Mark Caufield, former chief scientist, Genomics England.
All stakeholders will have to play their part in discussions and policy formation, and they will all have to accept that the ultimate objective is better health for patients. Their own interest and priorities must adapt to that priority – EAPM looks forward to an excellent event, see you on 17 September!
Artificial intelligence in medicine regulation
The International Coalition of Medicines Regulatory Authorities (ICMRA) has set out recommendations to help regulators address the challenges that the use of artificial intelligence (AI) poses for global medicines regulation, in a report published today. AI includes various technologies (such as statistical models, diverse algorithms and self-modifying systems) that are increasingly being applied across all stages of a medicine’s lifecycle: from preclinical development, to clinical trial data recording and analysis, to pharmacovigilance and clinical use optimisation.
This range of applications brings with it regulatory challenges, including the transparency of algorithms and their meaning, as well as the risks of AI failures and the wider impact these would have on AI uptake in medicine development and patients’ health. The report identifies key issues linked to the regulation of future therapies using AI and makes specific recommendations for regulators and stakeholders involved in medicine development to foster the uptake of AI.
The European Medicines Agency (EMA) writes: “There is a need to establish clear mechanisms for regulatory cooperation between medicines and medical device competent authorities and notified bodies to facilitate the oversight of AI based software intended for use in conjunction with medicinal products.”
Booster jabs spat
The head of the World Health Organization has called for a two-month moratorium on administering booster shots of COVID-19 vaccines as a means of reducing global vaccine inequality and preventing the emergence of new coronavirus variants. WHO Director-General Tedros Adhanom Ghebreyesus told reporters in Hungary’s capital, Budapest, that he was “really disappointed” with the scope of vaccine donations worldwide as many countries struggle to provide first and second doses to more than small fractions of their populations while wealthier nations maintain growing vaccine stockpiles. Tedros called on countries offering third vaccine doses “to share what can be used for boosters with other countries so (they) can increase their first and second vaccination coverage”. However, wealthy Western nations are ignoring the global health institution. France, Germany, the UK, Israel and Hungary have set out plans for third doses, or are already rolling them out.
The World Health Organization, however, condemned the rush by wealthy countries to provide COVID vaccine booster shots, while millions around the world have yet to receive a single dose. Speaking before US authorities announced that all vaccinated Americans would soon be eligible to receive additional doses, WHO experts insisted there was not enough scientific evidence that boosters were needed and said providing them while so many were still waiting to be immunized was immoral. “We’re planning to hand out extra life jackets to people who already have life jackets, while we’re leaving other people to drown without a single life jacket,” WHO’s emergency director Mike Ryan told reporters from the UN agency’s Geneva headquarters.
But top Biden administration health officials have concluded that most Americans will soon need coronavirus booster shots after reviewing a raft of new data from the US Centers for Disease Control that showed a worrying drop in vaccine efficacy over time.
Commission concern on possible return of internal EU borders
The Commission is facing a situation that it would like to avoid at all costs: a return to internal EU travel restrictions like the ones imposed last year as coronavirus swept the globe.
The Schengen Borders Code (SBC) provides member states with the capability of temporarily reintroducing border control at the internal borders in the event of a serious threat to public policy or internal security. The reintroduction of border control at the internal borders must be applied as a last resort measure, in exceptional situations, and must respect the principle of proportionality. The duration of such a temporary reintroduction of border control at the internal borders is limited in time, depending on the legal basis invoked by the member state introducing such border control.
The scope and duration of reintroduced border control should be restricted to the bare minimum needed to respond to the threat in question. Reintroducing border control at the internal border is normally only used as a measure of last resort, and is a prerogative of the member states. The Commission may issue an opinion regarding the necessity of the measure and its proportionality but cannot veto a member state’s decision to reintroduce border control.
Bruno Ciancio, the medical epidemiologist who heads ECDC’s surveillance activities, dismissed restrictions on travel as not supported by scientific evidence.
“I don’t think at this point in time travel measures within the EU would be justified,” Ciancio said. The scientist explained that travel, with the exception of the very start of the pandemic, “didn’t play a major role in the infection rates that we have seen in Europe.”
“It’s really a minor effect,” he said, while the main factor accounting for virus transmission was behavior within individual countries.
Seasonal viruses like influenza start spreading in “November, or in December, not in August,” said Ciancio. By contrast, it’s clear that the coronavirus “can peak in the summer, as well as in winter”.
Good news to finish – ‘Lights at the end of the COVID tunnel’
Francois Balloux, director of the Genetics Institute at University College, London, predicts “a few flares and outbreaks” in Europe this winter, but Prof Balloux says he is “pretty confident” that in countries with high rates of vaccination, including the UK, the pandemic phase of the virus will be over by the spring. “We are seeing the lights at the end of the tunnel,” he reckons.
That is all from EAPM for now – make sure you stay safe and well, have an excellent week, and don’t forget the upcoming EAPM event – here is the link to register and here is the link to the agenda. See you soon!