Press release - Observatory for transparency in drug policies (OTMeds) - Wednesday 8 December 2021
As Europe enters a fifth wave of COVID and the world witnesses the emergence of a new variant, the Observatory for transparency in drug policies (OTMeds) publishes 8 lessons to be learned in 2021 for 2022. We call on governments to implement transparency in medicines policies as soon as possible and to allow production of COVID vaccines in low-and-middle income countries.
1. If access is not promoted everywhere, variants will continue to emerge
On November 26, the World Health Organization (WHO) qualified as "worrying" the variant B.1.1.529, known as "Omicron", identified for the first time by South African scientists on a sample collected on the 9th. November. The data currently available suggest in particular an increased risk of reinfection. Scientists will still need some time to determine the characteristics of this new variant, including how existing vaccines work against it.
[EN] The New York Times (December 2021), "Fragmented reactions hinder global fight against Omicron variant"
[FR] Le Monde (novembre 2021), tribune « L’accès aux vaccins pour tous est une question d’éthique et de sécurité sanitaire mondiale »
[FR] France Inter (novembre 2021) : « Pauline Londeix : "Si on ne permet pas un large accès à la vaccination, on aura des nouveaux variants" »
[FR] France Info (novembre 2021) : "Pauline Londeix et Bruno Canard sur France Info le 29.11.21"
2. Voluntary initiatives do not work
Voluntary vaccine access initiatives for low-and-middle income countries, including the Covax initiative, have failed. By fall 2021, only 3.9% of populations in low-income countries and less than 50% of the world's population had received a first dose of a vaccine. A country like Sweden had received 9 times more doses from the Pfizer laboratory than all low-income countries combined. We have been saying it for months: the exit strategy cannot be based on the goodwill of pharmaceutical companies oriented by profit maximization, since they are listed on the stock exchange. States should refuse that multinational pharmaceutical companies to lead global vaccine policy.
[FR] France Culture, Les enjeux internationaux » (février 2021) « Accès aux vaccins : comment imposer aux pays riches d’en laisser aux autres ? »
3. The competitive approach to R&D has shown very significant limits
In terms of research and development (R&D) on pharmaceutical products, adopting a purely competitive approach seems problematic to us. However, this is what the States have favored since March 2020, both for pseudo-pragmatic reasons ("consultation would have wasted time") but also for reasons of geo-strategic and commercial competition. This is what prompted the company Sanofi to abandon its vaccine candidate in September 2021 when it was nevertheless promising. Its late arrival compared to Moderna and Pfizer would not have allowed Sanofi to make enough profit according to the firm. Yet, many public resources have been invested in the development of this vaccine candidate and many others. The New York Times "vaccine tracker" reported on December 3 that a total of 110 vaccine candidates were being studied.
This research is funded with a lot of public money, and a lot of the risk associated with this research has been absorbed by States. Volunteers have been mobilized for the final phases of clinical trials. It is therefore unethical to abandon research on these candidates on the pretext that the candidates would no longer be sufficiently promising financially compared to already existing vaccines, if this candidate shows other benefits in terms of health. This State of affairs clearly shows the limits of a competitive model boosted by huge amounts of public funds, while the profits mainly irrigate Moderna and Pfizer firms, without allowing access to vaccines everywhere that could enable a way out of the crisis.
[EN] France 24, October 2020 : "The race for a Covid-19 vaccine: Are lives at risk as countries try to find a quick fix?"
[EN] France 24, November 2020 : "The real vaccine? Pfizer claims its drug is 90% effective against Covid-19"
[FR] Le Monde, Tribune, Septembre 2020, Pauline Londeix, Jérôme Martin et Els Torreele : « La course au vaccin peut compromettre toute réponse adéquate à la pandémie »
[FR] France Culture, Débats, Août 2020, Antoine Flahault, Els Torreele et Pauline Londeix : « Covid-19 : quels seront les gagnants de la course au vaccin ?
[FR] AFP, Septembre 2021, « Sanofi arrête le développement de son vaccin à ARN messager contre le Covid-19 »
4. Dose donations to poor countries and a completely vertical approach do not work
On December 8, Reuters reported that Nigeria had thrown away 1 million doses of COVID vaccine. And indicated that these doses of AstraZeneca vaccines had arrived in Nigeria about to expire. Mass vaccination strategies are complex and rich countries are currently experimenting it, yet they ask developing countries to organize theirs around random dose arrivals and within very short time frames. The organization of immunization in these countries will continue to fail if it remains with such a vertical approach. Low-and-middle income countries must be allowed to produce vaccines and set-up vaccination campaigns.
In an Op-Ed for Le Monde, alongside Thomas Piketty and Cynthia Fleury in particular, we denounced it already in January 2021, "Africa must be guaranteed access to vaccines".
5. Acceleration of vaccination must be accompanied by campaigns & all other tools must continue to be used to reach the "hesitant"
In rich countries, vaccination campaigns have been hampered by health inequalities and vaccine mistrust. Health inequalities must be fought with social policies and strategies to reach out. Vaccine mistrust can be reduced by educational information campaigns, which explain what can and cannot with existing vaccines, which take into account fears to best address them. Public health data show that the sole constraint, "green/health pass" or vaccination obligation, is not enough, and is sometimes counterproductive in the long term when it is accompanied, as was the case in France this Summer, by government communication promising a "return to normal", denying the importance of keeping waring masks or other barrier gestures. Vaccine adherence, which is an essential issue given the limited duration of effectiveness of existing vaccines, will only be built by following the principles of public health policies and health democracy. The promotion of masks and barrier gestures should not be forgotten. FFP2 masks must be distributed free of charge, especially for health workers and to the most fragile people.
[FR] L’Humanité, décembre 2021 : « Covid-19. Et maintenant, doit-on recourir à l’obligation vaccinale ? #1 »
[IT] Caffe dei Giornalisti, dicembre 2020: “FRANCIA, IL RUOLO DELL’INFORMAZIONE SUL COVID: VIZI E VIRTÙ DEI MEDIA SUI VACCINI »
6. Low-and-middle income countries must be able to produce vaccines
Low-and-middle income countries must be allowed to produce vaccines, as they have been requesting from the World Trade Organization for a year (cf. the proposition of South Africa & India at WTO). The caricatural visions that claim they do not have the necessary infrastructure do not stand the test of reality: most of the medicines and vaccines used in Europe are today produced in low-and-middle income countries. If the production of mRNA vaccines is new, it is also new for producers in European countries, who had no experience in the field and who have benefited from technology transfers from Pfizer and Moderna.
[FR] Interview, Mediapart, mai 2020 : « Brevets des vaccins: «Plus de six mois ont été perdus» »
[FR] Le Monde, mai 2021 : "Covid-19 : « La levée des brevets sur les vaccins n’est pas une posture, c’est la seule voie possible »
[FR] Le Monde, juillet 2021 : « Seule une réponse mondiale coordonnée pourra mettre fin à la pandémie de Covid-19 »
[IT] Internazionale, Maggio 2021: “Battaglia sui brevetti dei vaccini e le altre notizie sul virus »
[IT] Domani, Op'ed, novembre 2021: "A fine mese la Commissione Ue ha una chance imperdibile per mostrare buon senso sui vaccini"
7. There must be transparency in contracts signed between multinational companies and States, including the European Commission
Transparency must be implemented throughout the drug and health product chain, and also on vaccines used against COVID. Contracts signed between states and firms must be published. States which have contributed billions of dollars to the development of vaccines must now and for all future contracts impose various clauses, in particular: impose a maximum selling price (today Moderna and Pfizer have the possibility of unilaterally increasing the price of their vaccine), based on rational elements which must be transparent (real investment by firms, state public aid, production cost, etc.), impose the availability of these vaccines in developing countries, impose a mandatory technology transfer to third-party producers wishing to manufacture these mRNA vaccines. These producers, if this measure is accompanied by the lifting of intellectual property rights, have the possibility of producing these vaccines. As was the case in the fight against HIV, tuberculosis and viral hepatitis, competition from generic producers is essential to allow greater access to health products.
The contracts signed with the firms must also be made public. It is not acceptable that MEPs, for example, have very limited access to it. This poses major democratic questions.
[FR] France Info, février 2021, Interview de Pauline Londeix : “Stratégie de production vaccinale en Europe: "nous faisons les frais de l'opacité" »
[FR] La Croix, février 2021, « Retards de livraison des vaccins : qu’a obtenu l’Union européenne des laboratoires ? »
[IT] Domani, novembre 2021 : "Vaccino Covid, l’Europa nasconde i contratti sulle dosi vendute da Big Pharma"
[IT] Domani, ottobre 2021 : "La trasparenza è l’antidoto all’aumento dei prezzi di farmaci e vaccini. L’Italia ha un ruolo chiave"
8. Conclusion: States must regain control of the chain of medicines, vaccines, tests and health products and not repeat mistakes on new contracts
In 2021, States continued to do what they had been doing for a long time: depending almost entirely on the goodwill of pharmaceutical companies to decide on health strategies and vaccine campaigns. It is not acceptable. In May 2019, the Member States of the World Health Organization (WHO) committed to implementing full transparency on the drug chain, aware that the sustainability of health systems and access for populations depended on it. This transparency, if it had been implemented earlier by the States, would have made it possible to manage the crisis in a completely different way. In 2022, States must regain control, allow access for all to COVID vaccines, this involves in particular the lifting of patents at the WTO, the obligation for companies to share their technology, and transparency on the drug chain, and by working with developing countries to end an ineffective only vertical north-to-south approach.
The companies that have marketed mRNA vaccines had promised that they would be able to adapt quickly to the arrival of new variants. Pfizer today announced that it would now take three doses of the vaccine to be effective against the omicron variant. In the new contracts that will be signed with the firms, conditionalities must be included, and the mistakes made must not be repeated.
Version française de ce communiqué.
Respectively former vice-president and former president of Act Up-Paris, Pauline Londeix and Jérôme Martin founded in June 2019 the Observatory for transparency in drug policies (OTMeds), to ensure the implementation in France of the “Resolution on Transparency”, a resolution on transparency in pharmaceutical markets passed at the World Health Assembly in May 2019.
In September 2019, OTMeds published a "transparency checklist", a document that according to us, brings together some of the essential information that must be available to the public regulator in order to assess the relevance of the price of a drug at the time of setting of its price. It has been used by several institutions. In October 2019, OTMeds proposed to French parliamentarians as well as to the government proposals for amendments and decrees so that France begins to implement at the national level the resolution on the transparency of the World Health Assembly in the framework of the social security finance bill. The Observatory obtained an amendment on the subject to be co-signed by France Insoumise and LREM, an unprecedented alliance which proves the value of the approach. Censored for formal reasons by the Constitutional Council, the amendment was adopted the following year following new work by the Observatory, as reported in this report by the World Health Organization (August 2021).
OTMeds has been invited by various institutions, research seminars, conferences in economics or intellectual property, to present our approach and the importance of the angle of transparency in preserving social protection systems. In France, we were heard by the Ministry of Europe and foreign affairs (2019), the Ministry of Health (2019), the CCNE (conseil consultatif national d'éthique) in June 2020 for its opinion n°135 on access to therapeutic innovations, by the Senate in November 2020 as part of the development of a bill creating a public drug center, by the National Assembly as part of the drug information mission, by the Institutional Review Board of the Institut Pasteur. Abroad, we were heard by parliamentarians from the German Bundestag around the Transparency resolution and the French amendment (February 2020) or the Belgian national ethics and bio-ethics council (March 2021).
We co-organized an event around the Transparency resolution and its applications with the Global Health Center in Geneva, in parallel with the World Health Assembly in May 2020. We also spoke at a session of the Fair Pricing Forum organized by the World Health Organization in April 2021.
In October 2021, we published a report for the group "The left" at the European Parliament on the possible "relocation of pharmaceutical production in Europe".
In two years, we have produced more than a hundred press releases, position papers, information notes and op-eds (Le Monde, Libération, Le Figaro, A.O.C, Domani, L'humanité, The Lancet).
Find our main media interventions at this link