WHA wrap — UK trials boost — Cancer Plan project peek – POLITICO
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— As the World Health Assembly winds down, we look at the latest news out of Geneva.
— The U.K. Treasury unveiled a raft of measures designed to boost the life sciences sector, including speeding up clinical trials.
— Two years since Europe’s Cancer Plan launched and a suite of projects are now up and running.
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WHA WINDS DOWN: For civil society, global health experts and journalists, the work of the World Health Assembly is drawing to a close as the most important items on the agenda are wrapped up. But for diplomats, the discussions stretch until Tuesday. More on what’s coming up further down, but first, we bring you up to speed on the latest news out of Geneva:
Tackling sexual abuse: The biggest stain on the World Heath Organization (WHO)’s reputation in recent years has undoubtably been the numerous reports of sexual abuse and harrassment leveled at its own staffers. Countries took to the floor Thursday to address the issue, offering recommendations, criticism and calls for change. The U.K.’s permanent representative to the U.N. in Geneva, Simon Manley, said it was a “shadow that has been cast over this organization by the incidents that have been uncovered in recent years” and that what was needed was “profound cultural change.”
‘Justice delayed is justice denied’: WHO DG Tedros Adhanom Ghebreyesus was also remarkably candid, telling delegates there are investigations that have been going on for five years or more, and acknowledging that staff were saying ‘justice delayed is justice denied.’ With a new deadline of 200 days for an investigation to be completed, he hopes this starts to change. He also said that nobody will report “if they don’t feel safe” or “trust the system.”
Filling the coffers: Thursday also saw discussions on the all important replenishment mechanism that is meant to be rolled out under an investment round in late 2024.
‘Get going with the governance reforms’: Ghana, speaking on behalf of African countries, called on the WHO’s Secretariat to “develop without delay the investment case, the target funding envelope and a roadmap for the implementation of the WHO investment round.” They also pushed for the immediate implementation of WHO governance reforms “to elicit greater confidence” as countries increase the amount of cash they give the organization.
ICYMI: One of the big moments of the week was the vote on a resolution condemning the war in Ukraine. Konrad-Adenauer-Stiftung has put together a fascinating map showing how countries voted on the resolution. Most notable is Africa, where almost the entire continent either abstained from voting or was absent from the room.
On the agenda today: Delegates will discuss progress reports on topics such as universal health coverage and WHO support to countries. As the main event peters out, so too do the side events. There are just a handful on the agenda today, including Gavi, the Global Fund and World Vision’s event on tackling community health worker program barriers, and the WHO’s roundtable on immunization.
And into the weekend: Items left on the agenda include the social determinants of health, and a continuation of discussion on those progress reports. On Saturday, the official WHO roundtable will be on the 20th anniversary of the adoption of the WHO Framework Convention on Tobacco Control — the only treaty that’s ever been agreed under the auspices of the WHO.
LOOKING TO NEW YORK: On the sidelines of the WHA, WHO chief Tedros and others spoke about the fact that the world is not on track with beating tuberculosis. Pointing to “new and powerful tools,” such as an all-oral treatment and rapid molecular tests, Tedros said leaders need to commit to concrete targets at the September high-level meeting on TB in New York. Targets include reaching 90 percent of people with TB prevention and care, using the WHO-recommended rapid test as the first method of diagnosis, and licensing at least one new TB vaccine.
**A message from PPTA: Achieving greater strategic autonomy for plasma through increased collection in the EU is crucial to ensuring sustainable access to plasma-derived medicines (PDMPs). The EU Substances of Human Origin (SoHO) Regulation should ensure that plasma donors can be compensated for expenses and inconveniences associated with the donation.**
UK LIFE SCIENCES BOOST: The U.K. Treasury unveiled a raft of measures late last night designed to boost the life sciences sector, including significant changes for clinical trials, regulatory overhauls and sector funding.
Power huddle: The news followed a meeting of Big Pharma, health care and life sciences leaders under the guise of the Life Sciences Council. Among the CEOs attending were AstraZeneca’s Pascal Soriot, GSK’s Emma Walmsley, Eisai’s Haruo Naito, Novartis’ Vas Narasimhan, BMS’ Giovanni Caforio, UCB’s Jean-Christophe Tellier, Smith & Nephew’s Deepak Nath and ABPI’s Richard Torbett, plus other industry executives.
Clinical trials: The Chancellor committed to cut the regulatory burden of approving clinical trials, speed up clinical research and improve access to real-time data via new Clinical Trial Acceleration Networks. The move was in response to James O’Shaughnessy’s review on commercial clinical trials and Angela McLean’s review on the life science regulatory system.
More cash: Money has been set aside to boost medicines manufacturing, locally-driven R&D and mental health — and there’s £250 million to spur the creation of pension investments into life sciences sectors. There’s even cash for a new railway line to link up science rockstars Oxford and Cambridge.
“These positive steps will put us on the front foot in the global race to develop and manufacture the next generation of medicines and technologies,” said Steve Bates of the BioIndustry Association.
But it comes after years of declining export value for the sector and the country losing out to Europe, the U.S. and China for clinical trials. It also comes as Big Pharma fights for a better drugs pricing scheme; today companies pay a sales tax of 27.5 percent. These issues didn’t go unnoticed during a House of Lords debate earlier in the day.
TRIALS AND TRIBULATIONS: Clinical trials are changing. That’s due to cost pressures, challenges in recruitment, the types of diseases being treated, and challenges thrown up by the pandemic. The Innovative Health Initiative, the EU-backed public-private funder of research, is exploring how to solve some of these issues, and shared some insights on Thursday.
Key takeaways: Platform trials that use one control group to test against multiple treatments hold great promise for recruitment in certain disease areas, and can allow several companies to test their products at once. But they can be hard to set up. Francesco Patalano from Novartis said getting regulatory approval for platform trials “is not easy”. However, regulators are interested in trying to improve this, he said.
Xavier Mariette of Paris-Saclay University said setting up a large trial to test treatments in the rare autoimmune disease primary Sjögren’s syndrome (pSS) took one-and-a-half years for the European Medicines Agency to approve. That’s before ethics committees and trial centers could be approached.
UK holdups: “We still have a lot of issues with the U.K.” he said, because they need separate approval from the Health Research Authority (HRA). We’ll delve more deeply into the U.K.’s plans to examine if that will change …
CANCER PROJECT SHOWCASE: In February 2021, the European Commission presented its Cancer Plan — a sweeping policy package aiming to pour investment into cancer prevention, diagnosis, treatment and survivorship in order to bend the mortality curve down, and fortify the bloc against a disease that will only become more burdensome as the Continent grays. Two years on, and the EU’s executive took the opportunity to showcase some of the projects it is funding in a webinar on Wednesday.
Cancer code: First up was Carolina Espina from the International Agency for Research on Cancer. Espina is co-leading the ECA5 project, tasked with developing the fifth edition of the European Code Against Cancer. Bringing together more than 60 experts from the worlds of epidemiology, prevention, communication and health literacy, the project will produce by early 2025 updated guidelines for the general public advising them how to reduce the risk of cancer and its consequences. Linked to the updated code is the BUMPER project. Wendy Yared from the European Cancer Leagues, who presented the project, said that it aims to develop a mobile app to help the Commission achieve its goal of making at least 80 percent of the population aware of the code by 2025 (with a project end date October 2024).
Screening in the spotlight: Also on the topic of digitalization, the CanScreen-ECIS project wants to make data collection for population-wide cancer screening easier by building data management tools. As Matthias Schuppe, deputy head of cancer at SANTE’s Health in All Policies Unit, pointed out, the 2003 Council recommendation on screening relied on ad hoc reporting to measure its efficacy. With a new recommendation out, proper digital infrastructure will allow for more systematic measurements of policy efficacy. For a full list of projects that were showcased, click here.
CPE PICKING UP STEAM? Cancer Patients Europe has a new partner — ThermoBreast, an EU-funded breast cancer diagnosis project. CPE is led by Antonella Cardone, who formerly headed the European Cancer Patient Coalition (which EU Influence has written about here), before an acrimonious split.
EVERYONE HATES BIG TOBACCO: French anti-tobacco group Alliance Contre le Tabac held a meeting with French MPs on Thursday in a bid to draw attention to what it sees as the big new threat coming from the tobacco industry — vaping (aka la puff). Elisa Braun of Paris Influence writes in to note that, while the gathering was formally organized by the Greens, it was unusual by French standards for the wide spectrum of support it attracted, including from politicians hailing from the center and the right.
Fuming: Speaking to Elisa, Alliance Contre le Tabac’s boss Loïc Josseran didn’t hold back: “Who can be against banning a product that will intoxicate and kill kids for sure?” Cigarette-makers watch out: He can count on the support of Health Minister François Braun, who earlier in the month said he wanted to crackdown on vapes.
New superbug-killing antibiotic discovered using AI, from the BBC.
BioNTech is proceeding with COVID shot in line with WHO guidance to target XBB strains, reports Reuters.
Denmark wants to lower abortion age without parental consent to 15, also from Reuters.
**A message from PPTA: In the EU, 8.4 million litres of plasma are collected annually for the manufacture of plasma-derived medicinal products (PDMPs). The private sector collects 46% of this plasma from just four countries: Austria, Czechia, Germany, Hungary. Only these countries are considered self-sufficient as they collect more plasma than the clinical need for immunoglobulins, the most in-demand plasma-derived medicinal product. While countries, such as Belgium , Denmark, Italy and France have ambitions to increase plasma collection, the growing clinical need for immunoglobulins outpaces their growth in plasma collection. Growth in plasma collection in the EU over the past 20 years has been possible mainly due to the contribution of the private sector. The SoHO Regulation should encourage Member States to have national plans in place to increase plasma collection, recognising the contributions that the private sector can make alongside the public sector and others.**