Alternative legal incentives for antibiotic research and development : The role and function of legal mechanisms

In Europe there are 25 000 deaths per year as a result of antimicrobial resistance and in the world the estimated annual number of deaths is 700 000. By 2050, it has been predicted that 10 million people per year could die from being resistant to antibiotic compounds. Market monopoly makes it possible for the pharmaceutical industry to make a profit that can recover the costs of R&D. Antibiotics courses are short and expected to be cheap. Additionally, there is a public health imperative to restrict the use of new antibiotics to mitigate the spread of resistance which makes it hard to recover extensive investments, creating an economic risk for the pharmaceutical companies. The economic incentives are insufficient for the development of new antibiotics and therefore there is a risk that we face a future without effective antibiotics. The purposes of this thesis is to review why the legal incentives in the patent system within the EU are insufficient in relation to research of new antibiotic compounds and to discuss how legal instruments could incentivise the development of new antimicrobial drugs. The thesis will review and analyse the following legal mechanisms in relation to antibiotics R&D; pharmaceutical patents, supplementary protection certificate, orphan drug designation, regulatory data protection and transferable patent rights. In brief conclusion, the thesis found that IP rights and regulatory incentives could serve as incentives for antibiotics R&D. The effect is however varying depending on if it is a novel class of antibiotics or analogues antibiotics. Overall, legal mechanisms are proven to be important and effective as pull mechanisms and that they carry the development of new antibiotic compounds forward. In combination with some political initiatives based on de-linking, legal mechanisms that are constant in comparison to politics can possibly ensure the pharmaceutical companies of reimbursement when conducting research in new antibiotics