Consequences of an SPC manufacturing waiver
In addition to eliminating the competitive disadvantages for EU generic and biosimilar producers, an SPC manufacturing waiver would also have a positive economic impact. On 05 October 2017, the EU Commission published the CRA study Assessing the economic impacts of changing exemption provision during patent and SPC protection in Europe (see download section). The study discusses the likely economic effects of an SPC manufacturing waiver as well as other issues. According to the study’s projections, an SPC manufacturing waiver could generate additional net revenue of €7.3 to €9.5 billion for the European generics industry by 2025, which equates to between 6 and 18 percent of the entire exports of the EU pharmaceutical industry to third countries. The CRA study forecasts potentially €1.2 to €2.1 billion of additional sales revenues for the biologics industry by 2025. An SPC manufacturing waiver could also lead to a total of 20,000 to 25,000 new jobs being created. For the API industry, the CRA study identified €254.3 million in potential additional net sales and 2,000 new direct jobs. The study emphasises that the commercial monopoly during protection periods will remain unaffected. The SPC manufacturing waiver will therefore not disadvantage the other part of the industry, and there would be no reduction in innovation incentives.