In Spain, most of the investment in health research and development is made by the public sector, mainly in research centers dependent on the Administration and universities, but once transferred to the pharmaceutical industry that public investment becomes invisible. That is one of the main conclusions of the Rights to Health Foundation’s report “Public Interest in Biomedical Innovation.” The study looks at how, although much of the investment comes from the public sector –a 62% compared to 38% from the enterprises— it loses control when the product or technology are transferred to the private sector. Thus, the Administration does not have the capacity to influence important matters, like pricing or the management of intellectual property, despite being the main buyer of medicine and sanitary products that result from public research.
The report also analyzes the conditions these transactions occur from universities and research centers to the enterprises. It notes how inventions developed in these public centers are usually protected by a patent and then transferred to companies through a license to exploit the technology or by ceasing ownership in exchange for financial compensation. In this process, the vast majority of these investigation centers and universities count on politics for the management and transfer of their industrial and intellectual property. However, as the report reveals, they do not include public interest criteria.
The criteria would be a measure to help make public investment visible when it is transferred to the private sector; transparency criteria that facilitate the access to all the information on the projects and inventions that have received public funds; measures to ensure that the final products have affordable prices that contribute to the sustainability of the system; or alternatives to the current model of management of the knowledge and industrial and intellectual property. On the contrary, the exploitive licenses are usually exclusive, giving rise to future monopolies. Confidentiality agreements are too common, closing the door for shared knowledge and transparency regarding accessibility in the registration and results of biomedical research generated from publicly-funded scientific activity.
Less state budget, more autonomy
At the budgetary level, the report collects the cuts in investigation in the past couple of years, above all at a state level, which has provoked a reduction in the number of projects, the abandonment of lines of research and poor, laborious conditions for the research personnel. Keep in mind that, from 2010 to 2016 and in global terms, the contributions from the autonomous communities have been as key as other European funding programs, particularly Horizon 2020. However, these new funding sources are not a substitute for the State Administration’s responsibility to increase investment and its commitment to scientific research.
The report highlights the need for instilling better mechanisms to recognize public investment in biomedical innovation, the fate of these investments and the necessity to make their contribution to the value chain of R&D visible.
The Companies’ Strategy
The pharmaceutical sector is the principal beneficiary of aid and loans granted in the health and biotechnology fields through the Center for Technological and Industrial Development, the agency responsible for granting aid to the industrial sector. Nine of the ten companies that received the most funding between 2010-2016 are pharmaceuticals. In addition to being significant companies in the sector and, in some cases, of large multinationals, half of them are interested in oncological projects, neurodegenerative disease and mental health issues.
The report lists a series of proposals that could be implemented to reverse this situation as soon as possible and allow for increased monitoring and social impact of public investment in R&D, taking as a reference the experiences in other countries. These include specific measures on intellectual property management, knowledge transfer or accountability, which would result in public information on what is being financed, how it is financed, what results are obtained and to whom they are transferred and/or licensed.
In addition, the study advocates for compromising on a definition of public interests and thereby establishing a set of criteria to ensure transparency, access and affordable prices for drugs and health products that result from public investment in R&D. This criteria would apply to grants, agreements that regulate university and public research organization participation in public-private projects, the participation of public health centers in clinical trials or tax incentives. In fact, in Spain, the Sustainable Economy Act already incorporates aspects of public interest and could serve as a starting point.
In conclusion, it reflects the need to implement policies and initiatives that transparently manage conflicts of interest in biomedical innovation and are committed to developing compromises on guidelines and recommendations to better define the relationships between the public and private actors.
You can find the report here.