A new European Union policy could increase the supply of legitimate pharmaceuticals in developing countries and thereby minimize the problem of counterfeit medicines, but many challenges remain.
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Analysis of EU Regulation 2019/933 on the SPC Manufacturing Waiver Exception
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Acknowledgements
The authors gratefully acknowledge B. Bergsson for research support. This research was supported by a Novo Nordisk Foundation grant for a scientifically independent Collaborative Research Programme (grant number NNF17SA027784). J.J.D. and A.S.K. receive research support from the Laura and John Arnold Foundation, the Harvard Program in Therapeutic Science, and the Engelberg Foundation. The funders had no role in the conception, preparation, or approval of the manuscript, or in the decision to submit the manuscript for publication.
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T.M. is a member of the Expert Board for Copenhagen Economics' “Study on the economic impact of SPCs, pharmaceutical incentives and rewards in Europe” (European Commission (DG GROW), Tender reference number 590/PP/GRO/SME/16/F/121).
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Minssen, T., Kesselheim, A. & Darrow, J. An export-only exception to pharmaceutical patents in Europe: should the United States follow suit?. Nat Biotechnol 37, 21–22 (2019). https://doi.org/10.1038/nbt.4324
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DOI: https://doi.org/10.1038/nbt.4324
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