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| The AmeriKat getting her weekly dose of SPC reform courtesy of DG Grow |
The Single Market Strategy, which was adopted in October 2015, announced that the Commission will:
"consult, consider and propose further measures, as appropriate, to improve the patent system in Europe, notably for pharmaceutical and other industries whose products are subject to regulated market authorisations".Then, on 17 June 2016, the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council (Health) adopted Conclusions on strengthening the balance in the pharmaceutical systems in the EU. It invited the Commission to conduct an evidence-based analysis of the impact of the EU's pharmaceutical incentives, including the SPC and the “Bolar” exemption, on innovation and access to medicines.
"The study will complement the analysis of ongoing legal study on SPC (you published a post last year - see here), and it will also analyse other incentives as requested by the Council in June 2016. The study will in particular analyse the economic effects of SPCs for pharmaceutical uses (human and veterinary) and plant protection, data protection and market exclusivity for medicinal products for human use. Evidence on the overall impact on availability and accessibility of pharmaceutical care for patients and the pressure on health systems across the European Union will be examined. The evidence provided by this study will hence support the policymaking in those areas."The technical specifications of the Tender seem to identify five areas of the study to be explored as follows (with focus on SMEs, as well):
- Overview of existing IP related incentives and rewards supporting pharmaceutical innovation in the EU and analysis of their actual use by innovators through out the entire product life cycle (focus on SPCs, data protection and market exclusivity)
- Overall economic effects of SPC, data protection and market exclusivity on innovation, availability and accessibility - An analysis of the current economic incentives of SPC and data protection, taking into account patent protection and the impact on availability and accessibility of pharmaceutical care for patients and the pressure of health systems across the European Union
- Economic impact of EU regulations on SPCs - Essentially, does the SPC Regulation meet the objectives in terms of scope and term of protection in accordance with the R&D investment and "lengthy market authorisation requirements"?
- Economic impact of rules on data protection and market exclusivity for medicinal products, including the impact on innovation, availability and accessibility of the medicinal products concerned and the impact on the health of the population (through the development and availability of innovative medicines or the lack of access to them) and the financial sustainability of health systems
- Economic analysis of the specific rules on market protection for orphan medicinal products in Regulation (EC) 141/2000 - The study aims to take into account the findings of the study on the economic impact of the Paediatric medicinal products Regulation, including its rewards and incentives and whether the incentives are proportionate to the goals of the Regulation in encouraging innovation, improving patients' access to innovative medicines.
The analysis will be filtered into supporting policy making in two respects:
- The Commission will use the study as one of the inputs into an evaluation report of the SPC system in the EU and to inform the decision on whether to come forward with a revision (notably with an option of establishing common SPC titles covering the entirety of the internal market)/scope and term/modification of the existing SPC system
- In view of the 17 June 2016 Conclusions, the study will also contribute to analysing the impact of the incentives listed above on innovation, availability and accessibility of medicines in the EU as requested by the Council.
The maximum amount of the tender is 280.000. The deadline to apply is on 8 February 2017.
