22 Sep 2010
New vaccines are the result of cooperation between the pharmaceuticals industry, enterprises in the clinical research and biotechnology sectors, universities and research institutes. A summary of a recent article by Juhani Eskola, Assistant Director General at THL, and Terhi Kilpi, Senior Medical Officer, published in Lääkärilehti (the Finnish Medical Journal).
Prevention of biological threats and promotion of a risk-free living environment are among the main duties of public authorities in securing the health and well-being of the general public. Vaccinations are one of the most effective tools available for this. Universities and public research institutes play a key role, with particular emphasis on their relationships with private enterprises engaged in vaccine development.
Development of a new vaccine starts when epidemiological research identifies a need to prevent an infection that forms a significant threat to population health. Microbiology, molecular biology and biochemistry are all involved in the work to create a suitable vaccine antigen, which is then developed into a product suited to mass production. The experimental vaccine is tested on cell culture models and in animal testing, before being tested in clinical trials comprising thousands of volunteers. The effectiveness and, particularly, the safety of vaccines are the subject of rigorous research during the entire development process of a new vaccine. The use of a new vaccine requires decisions that rely on expertise not only in population health, but in health care administration and health economics.
No single enterprise or institute can possess all the many kinds of expertise required for the process of developing a new vaccine. The development of vaccines has always been a team effort, involving participation from public bodies and private enterprises alike.
The sector research institutes in charge of developing national vaccination programmes – in Finland, this is the National Institute for Health and Welfare (THL) – participate in the process in a number of ways, including the early stages of research. The institutes in question have microbial strains and a broad base of expertise in applied research with a view to developing and testing model vaccines. However, such sector research institutes play the most important role in the final stages of the process. They are responsible for establishing whether a new vaccine is suitable for inclusion in the national vaccination programme, its use for various special groups and its cost-effectiveness. They are also in charge of making a synthesis of the available information and submitting a proposal for a vaccination programme to the authorities that ultimately make decisions on the programme. In preparing a decision on a vaccination programme, it is important to consider any special features and needs in the population that may have an impact on the structure of a vaccination programme or the choice of vaccine.
The institute responsible must assess the potential impact of a new vaccine as part of a comprehensive vaccination programme. It must take into account the people to be vaccinated, but also the individuals around them who will not receive the vaccine, and strive to predict the future impact of a vaccination programme, perhaps for decades to come. Since the effectiveness of vaccination programmes can vary considerably from one population to the next, expert institutes are required to possess in-depth knowledge of the characteristics of vaccines and of the effectiveness of vaccination programmes.
The product development plan and clinical trials strategy of a commercial manufacturer will only focus on the information necessary for obtaining commercial approval for the vaccine. They do not cover the information on public health and health economics that policy-makers need – at least not at the point when approval is granted.
When the sector research institutes that prepare vaccination programmes participate in the planning and implementation of vaccine research, they are able to ensure that questions that are important for public health and for the general public are included in the process.
THL evaluates its participation in the light of two separate requirements. THL’s primary task is to protect and promote the health of the population. As a special task included in this, THL is responsible for preparing a reform of the vaccination programme and for ensuring that recent developments in the field are taken into account in making decisions on the programme. Secondly, in accordance with decisions concerning the Government’s innovation policy, public bodies are required to support effective service production in their areas of expertise, in a way that promotes cost-effectiveness and general well-being.
Collaboration with private enterprises is part of the THL’s normal operations in many different forms: services subject to a fee, research collaboration, co-funded research in different spheres of operation and so on. In all areas, THL applies regulations and procedures that ensure that its expertise is independent of collaboration with private enterprises.
THL will only participate in co-funded research if the aims of the research serve THL’s own aim, e.g. the creation of a knowledge base for a vaccination programme. In such a context, THL will also contribute to the funding of research. The enterprise that is involved in co-funded research is expected to make a funding contribution of its own, both to the direct research costs and to the overheads. THL does not strive for financial gain at the expense of funding partners, but on the other hand it does not spend resources on supporting private enterprises. THL’s researchers do not receive any personal remuneration for co-funded research; the research is part of their normal work.
From time to time, discussion has emerged on the affiliations that vaccine researchers and institutes developing vaccines may have with the vaccine industry. At times, it has even been suggested that such contacts and even collaboration in general may be suspect. However, collaboration is the best way of creating new vaccines for preventing widespread or dangerous diseases. Avoidance of collaboration may have an even more unfavourable impact on public health than it would on pharmaceutical companies’ profits. In order to keep completely free of affiliations and contacts, it would be necessary for experts to work in total isolation. However, expertise is the result specifically of involvement in various forms of collaboration and of the interaction between the science community and public health policy makers.
In order to avoid inappropriate affiliations and to disperse any suspicions of such affiliations, transparency is essential in establishing collaboration, planning research and making funding arrangements. The provision of information and the background and terms of collaboration agreements must be transparent. This applies both to individual researchers and to entire institutes. In theory, this is a clear and simple proposition, but in practice, it is a more complex matter. The duty of researchers to report their ties and affiliations has been expanded to include their employers’ contacts with private enterprises. This makes it understandably difficult to draw a line, since an institute such as THL has collaboration agreements with dozens of companies.
Every participant – academic researchers, biotechnology companies, major pharmaceutical companies, sector research institutes and the competent authorities – all have a part to play in collaboration, and it is important to provide a clear and open definition of the part they play. Without collaboration, vaccine development would not be possible today. It is essential that researchers at universities and sector research institutes participate in vaccine development in order to secure a high scientific standard and to ensure that public health aspects are taken into account.
Short address: http://www.thl.fi/doc/en/23116
Updated 22 Sep 2010