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

University essay from Uppsala universitet/Juridiska institutionen

Author: Anna Sundberg; [2016]

Keywords: ;


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.

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