Deutsche Digest: Germany Undecided on COVID Tests & Treatments Talks at the WTO; Berlin's World Health Summit as an Alternate Policy Forum?
Newsletter Edition #163 [The Friday Deep Dives]
Today we bring you two different stories that illustrate Germany’s influential role in global health.
One tries to understand the German position on the discussion on tests and treatments at the WTO, and the implications on the EU position. (We also have an update on the TRIPS council meeting this week)
The second, is the emergence, and the significance of Berlin’s World Health Summit as an alternate policy forum outside of Geneva.
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Germany Undecided on COVID Tests & Treatments Talks at the WTO
Germany has been one of the most powerful, and some would say, the most influential actor that shaped the outcome on the TRIPS Waiver discussions at the WTO for the last two years, essentially opposing the proposal. This resulted in the adoption, in June 2022, of what was essentially EU’s proposal on clarifying the compulsory licensing system in the TRIPS Agreement. The Ministerial decision earlier this year resulted in a narrow waiver applicable only for the production of COVID-19 vaccines. Recall that German vaccine company BioNTech boosted overall GDP by 0.5 percentage points in 2021 from license fees. (Reuters reported that in 2020, Germany’s gross domestic product stood at about 3.3 trillion euros.)
Now, as WTO members discuss the extension of this decision to tests and treatments, the Germans are undecided on their position on this. What does this ambivalence mean? Or will it lead to an eventual opposition to the extension decision?
Sources familiar with these discussions told us that Germany may not be opposed to the discussion on tests and treatments unlike during the negotiations on vaccines, where it was staunchly opposed to the mechanism of waiving IP protection provisions to facilitate the production of vaccines. But this may not not mean the Germans will favor such an extension.
In response to our queries, a spokesperson from the German government said the following:
“In June 2022, the Federal Government approved the TRIPS decision of the 12th WTO Ministerial Conference, including the discussion on a potential extension to include COVID-19 therapeutics and diagnostics, provided for in paragraph 8 of the decision.
In the Federal Government’s view, this discussion should – just like the discussion on COVID-19 vaccines – be conducted on a factual basis. In the course of the WTO negotiations, it is especially important to clarify which – if any – specific problems in the supply of COVID-19 therapeutics and diagnostics could be remedied by an extension of the TRIPS decision. Also in need of clarification is the question of whether such an extension could have negative consequences for voluntary cooperation arrangements, for the development of further COVID-19 therapeutics, and for research and development generally. These issues may well involve different considerations to those that are relevant to the supply of COVID-19 vaccines. In light of the need for further clarifications in this regard, the Federal Government is not able to adopt a definitive position at this time.”
The spokesperson added, “The Federal Government is committed to ensuring the affordability of COVID-19 therapeutics and diagnostics in developing and emerging economies compared to current price levels,” in response to our question on similar discussions on the affordability of medicines at the EU level.
Whatever Germany decides will have implications on the overall EU position. A trade source from the EU, also told us that the EU delegation is waiting to learn from Germany on the position it should take in these discussions at the WTO. Officially, in discussions at the TRIPS Council, the EU has sought time for internal consultations, even as it continues to question the premise on whether IP has been a barrier in the access to tests and treatments.
In June this year, the clarification mostly affirmed members’ existing rights to over ride patent protection for the production of vaccines by waiving a specific provision in the current rules, also allowing for easier exports by manufacturing countries. By mid-December, members are to decide on the extension for tests and treatments.
Experts say there could be another reason for potential German ambivalence on this – namely health security considerations.
GERMAN INVESTMENTS & INTEREST IN GENOME SEQUENCING, DIAGNOSTICS
Global health observers point to German investments in genomic sequencing driven by motivations to bolster health security.
In December 2021, FIND, the global alliance for diagnostics, announced “an investment of US$21 million to accelerate the development, manufacturing, and launch of affordable, multi-pathogen, molecular diagnostic platforms, specifically for use in decentralized settings in low- and middle-income countries (LMICs).” FIND had said that the investment was funded by the German Federal Ministry of Education and Research (BMBF) through KfW and other donors, by way of grants to FIND. The investments will support development of assays for the differential diagnosis of COVID-19 and other respiratory pathogens (such as influenza) and to optimize their systems to meet the needs of LMICs, FIND said. It will also help towards regulatory requirements and companies’ manufacturing processes, to enable price reductions and increased volumes, and support regulatory submissions, a statement from December 2021 said.
In response to our queries, a spokesperson from FIND, also told us that “the German government through KfW is enabling FIND to support genomic surveillance activities.” FIND is “assessing multiple next-generation sequencing (NGS) workflows for genomic surveillance of SARS-CoV-2. FIND is also working with Global Initiative on Sharing Avian Influenza Data [GISAID] “to routinely monitor the impact of SARS-CoV-2 variants on diagnostic PCR tests, as well as to map sequencing capacity globally.” (Germany is the official host of the GISAID platform since 2010.)
Clarifying on the question on IP for products developed through the investments from FIND, the spokesperson said:
“The IP-related concerns around ensuring equitable access to health technologies and health products are generally quite different for diagnostics than for vaccines. For instance, as a rule, the effectiveness of either voluntary licenses to patents, or compulsory licensing of patents filed for diagnostic technologies is much more limited than it is for vaccines and for medicines. The reasons are not easily summarized in a short e-mail, but as three examples: (1) diagnostic platforms are often built from multiple different innovations bundled together, (2) in many instances, the “trade secrets” are more critical than filed patents; and (3) manufacturing know-how is often critical to low pricing for diagnostic tests, especially for innovative platforms. Thus, non-exclusive licensing of one or even several patents is generally insufficient to enable equitable access to new tools like the ones FIND is investing in through KfW support.”
FIND said that it has terms in agreements with companies that the organization supports, to enable the access to these tools in low- and middle-income countries at affordable prices.
In a recent report on its transition plan, the ACT Accelerator (of which FIND is a partner), said that the ACT-A Diagnostics Pillar will “focus its upstream R&D, manufacturing and regulatory activities on ensuring the availability and supply of safe, effective, affordable, accessible technologies and on expanding local manufacturing, technology transfer, support for market entry and regulatory approval. It will also scale its support to sustain self-testing and will expand fit-for-purpose genomic sequencing systems to guide public health action for COVID-19 management, as well as overall emergency preparedness, readiness and response. Together with the Therapeutics Pillar, it will increase its support to countries to address diagnostic barriers related to the roll out of new COVID-19 therapeutics.”
In addition, it is learned that Germany is now interested in discussing the non-exclusive licensing approaches used by the COVID-19 Technology Access Pool at WHO.
There is fair amount of interest and alignment with Germany’s goals in servicing the need for diagnostics, that may influence its position at the WTO.
PRICE GOUGING ON TESTS FOR COVID-19
“…There's another gouging going on. There's a lot of companies charging a lot of money for testing that's way, above any, markup. It's way above. It's profiteering, it's absolute profiteering. The governments came in well and put in place government-supported testing machines when we got lots of testing. And they deserve credit for that. Now, the market in a way should define the cheap testing regime, but it doesn't. Because the testing costs have shot back up. It is very hard to get tested in some countries for less than $100. Who's going to pay $100 for a test? That's a problem. We need to find better ways of doing systematic population-based testing that's free for people.”
TRIPS COUNCIL DISCUSSIONS IN GENEVA THIS WEEK
The urgency that seems to be dominating the response to the on-going COVID-19 pandemic is very different compared to what is unfolding inside the WTO. At the discussions at the informal TRIPS Council meeting this week, there seems to be adequate seriousness.
There appears to be an overall lacklustre engagement between WTO members on the discussions on extending the June 2022 Ministerial decision to tests and treatments. So far no text has been brought forward by members, according to Geneva-based trade sources.
As before, members are divided on whether IP constitutes a barrier in the access to tests and treatments with Switzerland, Singapore, Japan, Canada, Korea, the European Union and the United Kingdom contesting the premise. Some are seeking more information and facts around this decision, these include Colombia, Mexico, Costa Rica, Uruguay, China and Chinese Taipei. (See our earlier story.) Proponents of the extension decision include South Africa, India, Kenya, Tanzania on behalf of the ACP Group, Indonesia, Zimbabwe, Pakistan, Egypt, Bolivia, Argentina, and Venezuela.
WTO members have so far been unable to come together to propose concrete texts to take the discussions forward. Ambassador Lansana Gberie of Sierra Leone who chairs the TRIPS Council, had called for greater engagement and specific proposals in previous meetings. He is reported to have said that the absence of texts is concerning. And yet, the next meeting is now scheduled for November 22. It is understood that the Chair has said that it was pointless to have meetings if members continue to have the same positions, a Geneva-based trade source familiar with the proceedings said. Some have reportedly questioned the Chair’s position on this.
It is understood that bilateral discussions are expected to continue. With essentially six weeks to go for the deadline set by the ministerial decision, having fewer meetings with the wider WTO membership, shows a startling lack of urgency in making progress on these discussions.
In her statements to the European Parliament last week, Deputy Director-General of the WTO, Anabel González, articulated the position of developed countries on the extension decision.
She told MEPs, “My impression is that governments across the spectrum are engaging actively and in good faith with a seriousness of purpose that the issue demands. The two themes that I have heard in particular in the context of these discussions are firstly, they need to have a strong empirical or factual understanding of the current situation and the current challenges in relations to both, therapeutics and diagnostics, including on issues of supply and demand. And second, the possible need to clarify and to some extent the scope of therapeutics and diagnostics referred to. Because this technological fields are by their very nature, more diverse, and less well defined than the field of vaccines.”
She said that the WTO leadership believed members will be able to come to an agreement by December 17.
“NO SHORTAGE OF TREATMENTS, REDUCED DEMAND FOR TESTS”: MEXICO & SWITZERLAND
In a new communication put forward by Mexico and Switzerland, the members say that “available information shows that no shortage of therapeutics exists.” On tests, these members say, “ Global demand for tests has reduced and there is no evidence to suggest that supply is constrained relative to actual demand.” (TRIPS Council Discussions On COVID-19 Therapeutics And Diagnostics: Evidence And Questions On Intellectual Property Challenges Experienced By Members [IP/C/W/693])
In the paper, the countries emphasize the success of voluntary licensing arrangements. “As of 11 October 2022, 138 bilateral or Medicines Patents Pool-based voluntary licensing agreements comprising some of the most highly demanded treatments, have been signed between innovators and companies all over the world enabling them to join this fight by producing therapeutics. These agreements cover more than 127 countries collectively.”
They add that “The MPP-licenses are royalty-free. Thanks to these agreements, 191 production sites for COVID-19 therapeutics exist worldwide, i.a. in India, Bangladesh, the Philippines, Brazil, Paraguay, Egypt, South Africa or Kenya.” They suggest that tiered pricing adopted by some companies has also meant lower prices for low and middle income countries.
But many critics believe voluntary licensing has not been successful in meeting the demand for medical products during the pandemic.
Carlos Correa, who heads the South Centre in Geneva, told us that it is true that voluntary licenses may include not only the use of the patented invention but also know-how. “The problem, as shown during COVID 19, is that patent owners opt not to grant voluntary licenses and, hence, the argument about the superiority of such licenses is flawed,” Correa explained.
He points to the Article 7 of the TRIPS Agreement which says: 'The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology,...'. “But this has not happened in fact. One reason for this is that the strengthening of IP protection under TRIPS reduced the incentives for the right owners to transfer technology as they can supply (and control) foreign countries through exports while preventing imitation there,” Correa added.
ADDITIONAL QUESTIONS RAISED
Mexico and Switzerland raise a number of questions for the proponents on the extension. They ask the benefits of extending the TRIPS decision when there is demonstrated availability of therapeutics for COVID-19. They ask why the proponent consider it necessary to facilitate the issuing of compulsory licenses that do not contain technology transfers, training and other benefits that come with most voluntary license agreements. They question the need for facilitating the issuing of compulsory licenses, reportedly at a time when there is declining demand for therapeutics and their generic versions, and asked how would the proponents justify investments in such a scenario. Finally they ask the usefulness of extending the waiver, when “no country has made use of the possibilities provided for by the Decision to grant a compulsory license for the export of COVID-19 vaccines.”
Experts do not rule out a possible, emerging transatlantic understanding on the thorny issue of dealing with intellectual property matters in multilateral institutions in the context of health emergencies, and not only at the WTO.
Julia Dötzer contributed to this story.
Other relevant reading:
THE TRIPS AGREEMENT LAID BARE - Learning the lessons of COVID-19 to improve access to health technologies: Health Action International
Understanding Germany’s Trenchant Opposition To the TRIPS Waiver [August 2021, Rithika Sangameshwaran]
World Health Summit as an Alternate Policy Forum?
At the World Health Summit in Berlin last month, an earlier proposal for an additional governance mechanism at WHO, that seeks the participation of private sectors, was casually mentioned during a discussion. But for keen observers of global health governance, this immediately raised concerns on the legitimacy of forums such as the Summit in Berlin.
The proposal in question is the need for Committee C at WHO, first suggested by powerful interlocuters in global health – Ilona Kickbusch et al in The Lancet in 2008. The ask is straight-forward, and to many, it might make sense – to have an intermediate policy forum where other actors in global health can participate and interact with the formal governing body processes at WHO. While WHO member states would continue be the final decision-makers, other actors would have an opportunity to shape this process – reflecting the wider reality of a vastly transformed global health architecture. (See below on Committee C more in detail.)
Some argue that the time for such an idea may have come, given the cusp on which global health finds itself in. It signifies two developments, one, the power of WHO donors such as Germany in setting the agenda; second, the wider inevitable shift in the latitude that actors such as the Gates Foundation and others already have, in global health policy-making.
But shouldn’t such a transformation in governing processes be decided multilaterally, and not at a Summit with inadequate representation of all WHO member states?
WHAT IS COMMITTEE C?
In an article, “Creating a committee C of the World Health Assembly,” Kickbusch et al, drew a plan on the need and the functions of a new mechanism. They justified the need for such a mechanism to not only reflect the diversity of actors in global health, but also as a mean of better coordination. They further argued that WHO constitution empowers it to draw upon such a committee, citing Article 2 and Article 18 of the Constitution.
They said in 2008:
“The challenge is to find a workable mechanism to improve consistency of global-health action and coordination between many partners while respecting their independence and decision-making structure. Any decisions taken by a coordination mechanism are only as effective as the legitimacy given to them by those affected by the decisions. Coordination only works if it is accepted by those being coordinated.
….The mechanism we propose is to consider the establishment of a committee C of the WHA. This committee would debate major health initiatives by other key players in the global-health arena. It would provide the opportunity for these organisations to present their plans and achievements to the delegates of the WHA and the non-governmental organisations in official relations with WHO. It would also provide an opportunity to address coordination and common concerns of different partners in global health. Organisations wishing to make use of this mechanism would send their proposal to WHO's executive board, which would set the agenda for this committee as it does with the existing committees.”
The authors suggested such a committee would need rules of procedures to give space to other stakeholders by recognising the sovereignty of the member states in the final adoption of the resolution in the WHA plenary.
THE INDICATIONS FROM BERLIN
Many observers present at the World Health Summit expressed concerns, not only about the extensive private sector representation, but at the attempt to refashion the summit as a “policy forum” that could run outside of Geneva, and with the partnership of WHO.
Just as there were murmurs at the Summit of a Committee C like approach, senior officials from the German government hinted at these developments.
Senior official from the German government, Björn Kümmel, who has been a leading voice in Geneva, steering on issues such as the Sustainable Financing of WHO, said at the Summit:
“....There are lots of other actors: states, non-state actors, civil society, private entities and so on. Global health is being shaped on various sides [for] the better or the worse. And if we are honest with enabling WHO to be the lead [as a] coordinating authority, it needs to be able to engage with practically everybody who acts, and who has influence on global health. Whether they do that in a positive way or in a negative way. That was our position. Is it possible or thinkable that civil society or non-state actors are involved in decision-making. No. The true answer is no. I guess it will not be different in the next 10 to 30 years. But I think there is room for improvement with regards to decision shaping and there we are not exploring what we could be doing. I think there are good proposals on the table like the Committee C idea that is currently coming up again - hosting of non-state actors, before the assembly, a pre-discussion in order to inform member states delegations, so [that] member states delegations are informed by civil society and then take decisions. I think the decision-making will be done by member states, that's their prerogative and I doubt that anybody is able to change.”
To be sure, as WHO’s leading donors, Germany has been a fierce proponent of multilateralism in global health, articulating the importance of the role of all member states at WHO.
But support for WHO, from donors such as Germany, could be coming at a price for the organization, some fear. Berlin has already bagged the WHO Hub for Pandemic and Epidemic Intelligence Hub. Other member states have questions on the role of such a hub and have sought more clarity and accountability. Countries want to know the budgetary implications for such a hub in the long term, and the resulting commercial implications of sharing information with the Hub.
WORLD HEALTH SUMMIT A PLATFORM FOR PRIVATE INTERESTS?
Critics say that WHO risks being co-opted at such Summits.
A. Kayum Ahmed, an academic at Columbia University critiqued the Summit in an opinion piece in Devex, where he urged political and health leaders to “openly confront the powerful influence of nonstate actors such as the profit-driven pharmaceutical industry, the Bill & Melinda Gates Foundation, and McKinsey Consulting in shaping global health.” He argued that “the global health architecture is primarily shaped by Euro-American states that reinforce the power of the profit-driven pharma industry, and nonstate actors such as Gates and McKinsey.”
“Both Bill Gates and Gates Foundation CEO Mark Suzman were on stage at the opening ceremony of the WHS. That the Gates Foundation is the only institution with more than one speaker once again reinforces the outsized influence of undemocratic and unaccountable groups in the global health space.
The WHS needs to confront the unbridled power and influence of nonstate actors in shaping the global health architecture and must instead advance a human rights-centered global health order that ensures the full realization of the right to health for everyone.”
A. Kayum Ahmed in Devex
Remco van de Pas, a critical global health researcher, who has tracked the evolution of these discussions over the past decade, told us:
“In 2003, there was a democratic coalition of civil society organizations that tried to engage with WHO, but those efforts were shot down. Because at that time China, for example, was not in favor.
Subsequently, the idea of Committee C was proposed by Ilona Kickbusch et al. in 2008. They had proposed a sort of a World Health Forum between two Assemblies.
There were other efforts to improve CSO engagement subsequently in 2012 that were also not successful. Finally, in 2016, WHO adopted the FENSA, that has been more about managing risks and partnerships, but not so much about CSO engagement.
Now we have a situation where it is about the value these partnerships bring in ‘meeting strategic objectives’. But as a consequence, what we are now witnessing is that the World Health Summit, funded by the private sector and subsidized by the German government, has now captured the WHO.
Such a partnership is flawed, with limited legitimacy, since not all member states are represented at the WHS.
The WHS became an event on Pledging for Polio providing a platform to private foundations. This is even as legitimate decision-makers within WHO were relegated to side-events.”
WHERE DOES WHO STAND ON THIS?
WHO has said that the Summit is not a decision-making forum. Remember that this is the first time that the WHO collaborated on organizing the World Health Summit.
A WHO spokesperson told us in response to our queries:
“The World Health Summit is a forum for informal exchange and is not in any way connected to WHO governance or to WHO decision making process. In addition to its formal governance meetings, WHO and all other global health actors regularly engage in informal exchanges such as those during the WHS. For 2022 WHO co-organized the World Health Summit. No decision on future collaboration has been taken. WHO regularly co-organizes conferences with governments and other public or non-profit partners.”
If in due course, “Committee C” like models do become a reality, it will be another vote for multistakeholderism so willingly embraced not just by the international organizations, but also by member states themselves.
Response from World Health Summit [Received post publication on 9, November 2022]
“The World Health Summit is the unique international strategic forum for global health. It brings together stakeholders from politics, academia/sciences, the private sector, and civil society from around the world to set the agenda for a healthier future by inspiring innovative solutions for better health and wellbeing for all. We aim to strengthen collaboration and open dialogue guided by science, foster global health as a key political issue and promote the global health debate in the spirit of the UN Sustainable Development Goals.
The World Health Summit stands for a science-driven, evidence-based and broad approach to global health development. From our conviction it is key to be interdisciplinary, science-based, cross-sectoral, and strive for concerted action. This approach is vital to set the global health agenda for the years to come.
Additionally we do promote the concepts of health as a human right, health in all policies and health is a political choice along with good governance as political decisions almost always affect human health.
The World Health Summit was founded in 2009 on the occasion of the 300-year anniversary of Berlin’s Charité University Hospital and is traditionally held under the patronage of the German Chancellor, the President of the French Republic, the President of the European Commission, and the Director-General of the World Health Organization (WHO).
The academic foundation of the World Health Summit is the M8 Alliance of Academic Health Centers, Universities, and National Academies of Medicine and Sciences, a unique network of leading academic health centers, universities, and research institutions from all over the world. In addition to the World Health Summit in October in Berlin, the M8 Alliance organizes annual Regional Meetings and Expert Meetings around the world. Against this background, the World Health Summit is a very good and sensible addition to the annual World Health Assembly. We do not aim to be another policy forum but instead to be a forum with strong scientific, civil society and private sector involvement that connects with state actors and political decision makers.
For the World Health Summit 2022 we collaborated closely with WHO especially with regards to the main conference program and the engagement of member states as well as international health organizations.”
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