The counterplan means that governments funds the sectors dictated by the sectors of the aff – makes any industry deficit irrelevant

4. The great paradox: public funding but private properties Before introducing the concept of inclusive right and enforceability of Commons, it should be argued why the vaccine against Covid-19 should be considered a Commons in the first place. The first reason, investigated in this section, is the public funding contribution.

The Covid-19 pandemic resulted in drastic economic and social dislocation.66 Given this unprecedented situation, countries all around the world—including the EU, UK, Germany, Canada, and USA—started to accelerate the development and manufacture of treatments and vaccines, by allocating in total $9 billion of research funding from the beginning of the pandemic to the half of 2020, most of the times to private companies.67 By addressing the USA as an example, it can be immediately understood how the public funding have been extremely important for the R&D of every instrument (vaccines, therapeutics, etc …) needed to defeat the virus. The USA alone contributed with 35 per cent of all the public funding, focusing it mostly on a domestic level, through large grants allocated to US-based pharmaceutical companies.68 Even before the pandemic, the public commitment in pharmaceutical R&D has always been consistent in the USA. With an annual budget of $30 billion, the US National Institutes of Health (NIH) is the world’s largest single funder research in the life sciences, providing one-third of the biomedical R&D in the USA overall, and most of the funding for the basic biomedical research.69 Despite the substantial investment made by the government, and ultimately by the public at large as taxpayers, the property of the vaccines and treatments still belongs to the pharmaceutical companies that allegedly developed them. For instance, with regard to the mRNA technology implemented in the vaccines manufactured by Moderna and BioNTech/Pfzer that own the relative patents, as observed in Section 2, the NIH publicly funded 174publications in PubMed (PMID) in relation to this type of vaccines, a number which equals to 23 per cent of the total amount of 767 PMID.70

Despite the total lack of international instruments to address the issue of fair recognition of each contribution to a specific invention, there is one legislative example—it will be seen whether it is effective or not—thanks to which the public efforts in developing and manufacturing pharmaceuticals can be recognized in the USA: the Bayh–Dole Act, approved by the Congress in 1980 to facilitate the US technological innovation.71 This legislation allows the government to apply so-called ‘march-in’ rights, which give the possibility of granting a licence to a company to develop an invention protected by patents but financed through public funding, even against the will of the patent holder.72 More specifically, at first, the government can require the contractor or successors in title to grant a ‘nonexclusive, partially exclusive, or exclusive license’.73 If the patent owner refuses to grant it, the government will grant the licence itself.74 However, strict criteria must be complied with if the government wants to implement this ‘march-in’ mechanism. These rights can only cover inventions that are ‘conceived or first actually reduced to practice in the performance of work under a funding agreement’.75 This is a first noticeable obstacle, since the government often provides only indirect contributions to the specific technology and the related drug development, by for instance identifying biomakers or analysing certain diseases.76 In addition, there are four circumstances under which these march-in rights can be exercised; the most relevant of which states that the action must be taken when there is a necessity ‘to alleviate health or safety needs’.77 This provision seems to be quite broad and unclear, and some authors, such as Kapczynski, have observed that it does not solve the problem of excessive pricing,78 a problem that instead is likely to occur especially in the start of a pandemic where the demand for medical help is quite high, and the offer is not that consistent. Therefore, it is no surprise that these march-in rights have never been properly applied in the 40 year plus history of the Bayh–Dole Act, and the main reason of the various denials was exactly that the drug pricing was not so excessive as to trigger the march-in mechanism, in the sense that this was not considered a prerogative to accomplish health or safety needs.79

Considering the ineffectiveness of this legislative act, the question now is whether there is a more effective way to recognize the government contribution to the development of vaccines and treatments against Covid-19. If a system of fair pricing is to be implemented, some authors believe that one of the most important factors in defining such fair price is the accounting of the public funding, in the sense that, once the government reduces R&D cost and risk, its investment is directly part of the input in the development of the drug, and the price should represent such input.80 Once again in the USA, an enacted law allows the government to override a patent and purchase the invention covered by that patent at a competitive price.81 Patent holders should be entitled to a reasonable compensation by taking into account a variety of aspects, including any license terms and R&D investments made by the patent holder.82 In the pharmaceutical context, this provision has been used in 2001, when, during the anthrax scare after the 9/11 terroristic attack, a proposal was made to import generic versions of the antibiotic ciprofoxacin, and this led the patent holder in that situation, the company Bayer, to cut its price.83 Therefore, through this provision the government can have a consistent leverage for the reduction of a drug price, either through voluntary agreement with the patent holder or generic procurement.84 Although this legal instrument seems to have a better effect in terms of recognizing the public funding contribution than the Bayh–Dole Act, there are some aspects which remain quite debatable. It is true that the process is straightforward, and patent holders cannot prevent the federal procurement agents to accept bids to contracts and to not consider the status of the patent. However, it should not be forgotten that the rightsholders are still entitled to sue for compensation before, at the first instance, the Court of Federal Claims,85 and this would definitely pose a frst obstacle to the process.86 Lastly, from a more political point of view, it is highly difficult to imagine that the US government would implement this mechanism by going systematically against the interests of the patent holders. Hence, this provision has not been recently applied in the pharmaceutical context. Perhaps a more radical intervention would be needed, and an inclusive right for vaccine and other life-saving treatments could represent that radical solution.