We demand measures that guarantee universal access to vaccines

The current situation reflects a system conditioned by the market, very sensitive to economic interests.

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States put all mechanisms in place to respond to a crisis: they have boosted R&D with their investments, they have supported large-scale clinical trials, they have supported the production capacities of companies and they have facilitated regulation, approval and rapid market launch of vaccines. They have even taken much of the responsibility in case of unwanted effects. Nevertheless, the products resulting from all this investment have been placed in the hands of the usual market rules. The current situation reflects a system conditioned by the market, very sensitive to economic interests and where the States and the European Commission have little capacity to act in defense of citizenship and public health.

This loss of control is a consequence of the opacity with which contracts are usually negotiated. Indeed, the purchase agreements between the States and the pharmaceutical industry have been reached in absolute secrecy. The lack of transparency in public contracts is difficult to accept in democratic systems and raises many doubts as to whether the general interest is protected.

To date, the Commission has partially published three of the eight contracts signed with vaccine-producing companies. The first to go public was Curevac, then Astrazeneca and, most recently, GSK / Sanofi, all with many pages and paragraphs crossed out. All this has only happened after intense public pressure campaigns by civil society and institutions, including the European Parliament itself. From the parts that have been made public, we know that:

• The intellectual property and exploitation rights of the licenses are completely assigned to the companies. This means that all profits are exclusively for these pharmaceutical companies, although the States have invested a lot of money in research and have supported the whole process through the so-called Advance Purchase Agreements for vaccines.
• The companies are exempt from liability if there are claims due to lack of efficiency or for adverse effects or damages of any kind, and all compensation is borne by the Member States, that is, the citizens. Possible losses are “socialized”. This is expressly stated in art. 6 of the Agreement between the European Commission and the Member States on vaccines against COVID-19: the States fully assume the responsibility that the use and distribution of the vaccines entails, exonerating the vaccine manufacturers from the responsibility that said manufacturer usually assumes.
• The European Union has made significant economic and regulatory efforts to enable the creation of vaccines. In other words, the framework for aid to the pharmaceutical industry by the EU ‘is the equivalent of an insurance policy by transferring part of the risk incurred by the industry to public authorities in exchange for guaranteeing Member States equitable and affordable access to a vaccine, if available. ‘. As explicitly recognized in this document, through advance purchase agreements with vaccine producers and through the Instrument for the Provision of Urgent Assistance (ESI) we know that, among many other measures, more than 2,700 million have been helped. of euros. As a counterpart, “obtaining a certain number of doses of vaccines within a period and at a fixed price” had been set, which is now unilaterally breached by a pharmaceutical laboratory (page 3 of the document) and seems to be reduced to a mere commitment to activity, not results. The formula used in the contract refers to “reasonable best effort.”
• The companies maintain control in certain key aspects that affect the sovereignty of the States.. One of the contracts states that the company will have to authorize the donation or sale, even to WHO, of any surplus vaccine that a country has bought. In other than the company reserves the right to declare the end of the pandemic. These contractual clauses represent an obstacle to the fulfillment of the cooperation objectives in public health that the European Union has set. Contracts signed with private parties prevent the European Union from meeting its objectives of “global solidarity” expressly set out in various Commission texts.
• There is an imbalance of forces between the Commission and its Member States, on the one hand, and the pharmaceutical industry, on the other. A time like the present would require that the licenses of vaccines were not exclusive so that any laboratory could increase production capacity around the world. The important and priority now must be to save lives.
• Assuming the monopoly for the commercialization of these products at a time of pandemic will delay access to the vaccine for millions of people, also in our country, due to the effects of excessive prices and the funnel in manufacturing and distribution. Recent data from John Hopkins University, published in the British Medical Journal, shows that almost a fifth of the population will not have access to the vaccine until at least 2022, and the People’s Vaccine Alliance warned that 9 out of 10 people in the Poor countries will not have access to the COVID-19 vaccine in 2021.

For all this, the signatory organizations ask:

1.- Recover the value of public health. Faced with a situation as absolutely exceptional as the one we are experiencing, public health and people’s lives must prevail over any other economic interest. Our legal system already makes it possible for this to be the case by preventing the exploitation of a patent from being carried out in a way that is contrary to public health. Moreover, if necessary and in an exceptional situation, it would even allow a law to declare its public utility or social interest to expropriate a patent through a fair compensation for the vaccine manufacturer.

2.- Transparency in all contracts signed between the European Commission and pharmaceutical companies. Spain must demand access to them, guaranteeing a responsible exercise of accountability and the firm defense of the public interest and equitable access to vaccines, medicines and diagnostics.

3.- Criteria for public return on all investment made by States that ensure, among others, that the knowledge generated is shared and licensed to third parties under non-exclusive conditions.

4.- Prices at manufacturing cost, duly audited and discounting public aid where both public and private investments are clearly and precisely reflected.

5.- That Spain review its position on the proposed temporary suspension of intellectual property rights of applicable knowledge to combat the COVID-19 pandemic silver in the World Trade Organization by India and South Africa and promote a change of position by the European Commission and the rest of the European Union states before the Council of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
As noted by the World Federation of Public Health Associations (WFPHA), the proposal “seeks to address the constraints of low-, lower-middle-, and upper-middle-income countries (as defined by the World Bank) to have timely and affordable access under conditions of competitive market to COVID-19 diagnostic kits, medical devices such as respirators and, particularly, vaccines and drugs to combat the virus. This has been a commitment that the Commission has made in different documents and we demand its fulfillment. This is established in the aforementioned Communication of the Commission of June 17, 2020, where it is stated verbatim:
“The Commission also supports the voluntary sharing and licensing of intellectual property related to COVID-19 therapy and vaccination, in line with the recent Resolution of the World Health Assembly. To promote equitable global access and fair returns on investments. ”

6.- That the Commission explore the application of Article 122 of the Treaty on the Functioning of the EU (TFEU) so that, if necessary, it adopts exceptional measures such as the suspension of patents and the transfer of technology that is required to expand production takes place. Likewise, it is necessary that both the Member States and the European Commission itself take a step forward and become part of the WHO COVID-19 Technology Access Pool (C-TAP) initiative.