Transparency in Negotiation of European Union With Big Pharma on COVID-19 Vaccines

Abstract

Immunization through vaccination represents one of the most cost-effective public health interventions and the main tool for primary prevention of communicable diseases. Vaccination programs and vaccine prices, however, vary considerably among and within countries in the European Union (EU), because of the differences in the way healthcare systems are organized at the national or regional levels. These differences may lead to a new threat represented by the so-called “vaccine nationalism” that keep negotiations with the pharmaceutical industry behind the closed doors of each single nation, thus undermining global efforts to ensure fair access to vaccines for everyone (1). The severity of the recent COVID-19 pandemic is urging a major change in our capabilities to respond in the most appropriate and coordinated manner to the emergency situation. Transparency about the different roles of all stakeholders, either public or private, of vaccine manufacturers, and of health authorities and, most importantly, transparency in negotiations regarding vaccine price, could help avoid misconceptions, thus strengthening the collaboration required to protect against the pandemic. New vaccine pricing is a complicated process, including target population analysis, mapping of potential competitors, quantification of the incremental value, determination of the vaccine positioning in the marketplace, assessment of the vaccine price-demand curve, calculation of the costs of manufacturing, distribution, research and development, and inclusion of the various legal and regulatory expenses (2). The effective final price of the new vaccine may, eventually, be different for different purchasers because of various discounts, promotions, and incentives that the manufacturers may apply considering geographic and economical situations, as well as different times of the year, especially for flu vaccines (3). Transparency in the negotiation for vaccine prices has been a matter of debate for many years. In 2014, WHO launched the vaccine product, price, and procurement initiative, named Market Information for Access to vaccines (MI4A), aimed to improve vaccine price transparency (4). Thanks to the database created by the MI4A and improved price transparency, many low- or middle-income countries increased their possibility to access information, their capacity to negotiate affordable prices and strengthen their access to affordable vaccines (5). However, the issue is still far from being resolved. The emergence and subsequent global spread of the 2009 A(H1N1) influenza, also known as swine flu, with nearly 2,000 deaths in the EU, prompted health authorities around the world to review their response and to improve the reaction to the pandemic. During the 2009 pandemic, vaccine manufacturers greatly increased influenza vaccine production capacity and adopted a “tiered-pricing” strategy, where the price of a vaccine was mainly based on the level of income of the country (6). At that time EU member states struggled to obtain sufficient quantities of vaccines as quickly as needed and had to accept unfavorable contractual terms (7). The most developed countries placed large advance orders for the 2009-H1N1 vaccine and bought virtually all of what the vaccine companies could manufacture. National interests clearly prevailed over global solidarity. Wealthier governments that had provisional contracts with vaccine makers monopolized the global vaccine supply. By means of such contractual obligations, manufacturers committed all their capacity to produce and deliver vaccines to those who could pay the most (8). As a result, the 2009-H1N1 vaccine production affected the amount and timing of vaccines available for developing countries. Even though WHO entered talks with manufacturers and developed-country governments to secure some vaccines for developing countries through monetary donations both from manufacturers and developed countries, such donations still left the developing world with limited supplies or the vaccines arrived too late to be of much benefit. However, the impact of the H1N1 virus was less severe than anticipated, and health authorities of many countries had to face the problem of stockpiles of unnecessary swine flu vaccines. They had to negotiate with manufacturers over the suspension of delivery for surplus vaccines, and they tried to sell or donate at least part of them. The experience with previous pandemic flu prompted the manufacturers and the health authorities to work together to enhance global access, and to strengthen future preparedness. In 2018, a multidisciplinary expert panel was invited by the EU to identify measures and actions to improve vaccination coverage and to encourage close cooperation and better integration of public health and primary care services among member states in the EU¹. Among the changes proposed, there were some crucial scientific and technical improvements to rapidly select optimal vaccine viruses, actions to speed up vaccine production, and instruments to implement vaccine supply by means of the establishment of appropriate agreements prior to a pandemic. However, was that experience useful in improving our ability to combat the actual COVID-19 pandemic? Are we facing a replay of the past H1N1 influenza pandemic of 2009, with wealthy countries hoarding the vaccines? A concern was raised regarding transparency of the different roles of all stakeholders and about price, liability, and availability of vaccines. Full transparency of the vaccines' contracts, as well as the publication of clinical trials data before marketing authorizations are granted, is requested and this represents the key to widespread use of potentially life-saving vaccines. The global COVID-19 pandemic has stricken the EU with almost 17 million people infected and more than 400,000 deaths...