Stakeholders Must ‘Fully Engage’ If WHO’s Medicines Access Platform Is To Succeed
Executive Summary
Delegates at the European Health Forum Gastein outlined the challenges facing an international effort to improve access to costly new medicines across the World Health Organization’s European region, insisting that the key issues had to be addressed “collectively” and without “finger pointing.”
A “historic moment,” a “watershed” and a “milestone.” Just some of the words used at an international conference last week to describe the mandate given to the World Health Organization to establish a multi-stakeholder European platform on improving access to new, high-cost medicines.
But the initiative will face many challenges, such as how to balance the interests of patients and health care systems with those of the pharmaceutical industry, and how countries can be persuaded to pay for high-priced novel therapies whose actual benefits are still uncertain. All this in the context of a “permacrisis” characterized by the COVID-19 pandemic, the war in Ukraine, climate change, economic crises, the rise in non-communicable diseases, and other factors.
Moreover, the platform will only make progress if there is full engagement from all stakeholders and the key issues are addressed “collectively and constructively,” delegates to the 2022 European Health Forum Gastein (EHFG) heard during a session on “Aligning the stars for access to novel medicines.”
The platform is being established after delegates from the 53 WHO European region countries signed a statement backing the move on 12 September. The agreement was reached against a background of growing concern over escalating drug prices and in particular the pressure that novel medicines place on health care budgets. (Also see "New WHO Access Platform Could Mean Tiered Pricing In Europe" - Pink Sheet, 15 Sep, 2022.)
The idea is that the platform will build on the achievements of the Oslo Medicines Initiative (OMI), which was launched in 2020 by the WHO and the Norwegian government to create an “environment of mutual trust and cooperation” among stakeholders such as the pharmaceutical industry, governments and patients, with a view to improving access to innovative medicines.
The 12 September ministerial session of the World Health Organization Regional Committee for Europe in Tel Aviv, Israel, at which the statement was agreed, was by all accounts a ground-breaking event.
Hans Kluge, the WHO’s regional director for Europe, told the EHFG audience the session was “quite something. Sitting around the same table we had, for the first time, member state ministers, patients, the private industry, all with one commitment: to tackle the remaining challenges so that we can make access a reality.”
Kluge said that ministers shared their views “openly and frankly” because it was a “closed door” meeting that revealed the “personal and professional tensions in providing access to these novel high-cost medicines, especially when there is so much uncertainty over whether or not they will actually deliver the promised benefits.”
Some in industry say that “the climate for innovation is not good enough, especially around patents,” Kluge observed. “We also heard that there needs to be better evidence from the industry side so that you can actually understand what you're paying for. Some mentioned that the focus on pricing is misplaced, that this is only one element, given that the volumes for these novel and effective products are so low.”
Now, Kluge said, “we need to move forward with purpose and determination. It's time to stop discussing our differences and find areas of common ground for concrete action. And we believe that by putting patients first, there is enough of a shared agenda for us to move forward.”
But he cautioned that progress could only be achieved if issues were “addressed collectively and constructively rather than by pointing fingers.” The WHO’s “neutral platform” would include “all stakeholders in the same spirit of collaboration we have seen since the beginning,” he added.
How To Square The Circle
Another senior WHO official, Sarah Garner, told the EHFG audience: “We wouldn’t have any medicines without industry, so we need that innovation, but we also need our health care systems to be sustainable. So how do we square that circle?”
During the OMI process, she said, “we felt that while there was plenty of technical work, what was missing was real discourse between the stakeholders” about how to tackle the access problem. There were “very polarized views about what was causing it and whose fault it was, and those conversations seemed to have been going round, certainly throughout all my career, and getting more and more entrenched.”
"It is time to get out of these trenches and try to focus on the solutions” – Sarah Garner, World Health Organization
Garner, who is acting program manager for access to medicines and health products at WHO Europe, said it was time to “get out of these trenches and try to focus on the solutions.”
A key challenge would be access in low- and middle-income countries (the WHO European region stretches from Spain in the west to Russia and Kazakhstan in the east).
“For high-income countries, we know that the high-price medicines generally are cell and gene therapies, and maybe some of the newer cancer medicines,” Garner noted. “But for the low- and middle-income countries, it's a different set of medicines we're talking about. These cell and gene therapies are far out of the reach of those populations… “how do we bring those countries along with us?”
Next Steps
As for the next steps for the platform, Garner said “we want to get real with this and really try and identify what might work for all the stakeholders. We have some early ideas, but we need more inputs. So I'm asking everybody to engage again with this… we want the coalition of the willing to come and shape what the work looks like going forward.”
Horizon scanning would be key, she said. “We have many of these new high-cost medicines on the horizon, which is great news for patients, but they're going to represent a massive challenge for our health care systems. So let's be aware of them, let's plan.”
New funding arrangements would also be needed, Garner added, noting the voluntary and collaborative cross-country mechanisms being tested in Europe and elsewhere.
Stakeholder engagement would be vital too, she said, stressing the voluntary nature of the platform.
“WHO is not mandating anything. We're not mandating what the payers should be paying for. We're not mandating what the companies will be charging, which molecules they're going to be bringing through.”
The WHO is “acting as a neutral platform on which our stakeholders can come together,” Garner added. “Their interaction and engagement is critical for this initiative to achieve success, and that is everybody: the public sector, the private sector and other non-state actors.”
A subsequent Pink Sheet article on the EHFG medicines access session will look at the views of the pharmaceutical industry, patient organizations and payers on how Europe can deal with new therapies that could “break the bank.”