Impact on R&D

Impact of SPC Manufacturing waiver on R&D INVESTMENT in Europe according to European Commission according to the official studies published by the European Commission

European Commission reported:

  • An SPC manufacturing waiver for export AND stockpiling would be the most effective and simplest option”,Impact Assessment, p. 105.
  • The actual SPC system “ has two unintended consequences that were not foreseen, namely preventing generics/biosimilars (1) from being manufactured in the EU and exported to third countries (where no legal protection applies) during the EU SPC term, and (2) from being manufactured in the EU (and then stored) early enough to be placed on the EU market immediately from day-1”, Impact Assessment, p. 15.
  • “The main consequence of the above-mentioned problems is increased relocation and/or outsourcing of the manufacturing of generics/biosimilars outside the EU, and loss of business opportunities inside the Union more generally”, Impact Assessment, p. 19. “As mentioned above, such a waiver could potentially reduce the risk of relocation, not only of manufacturing, but also of R&D (in the biologics/biosimilars sector)”, Impact Assessment, p. 41.
  • Therefore, the impact on R&D with the actual system:
  • Loss of know-how and a brain drain of highly-skilled jobs, especially in the biosimilars sector, where R&D is increasingly shifting to other countries, notably in Asia”, Impact Assessment, p.20.
  • Relocation of R&D, in particular for biosimilars: the biosimilars sector is R&D intensive, and R&D for biosimilars tends to be located where manufacturing takes place. If manufacturing of biosimilars is rendered less attractive in Europe, then there is a risk that R&D for biosimilars will also leave the Union, causing Europe to lose its related expertise and competitive advantage”, Impact Assessment, p. 20.
  • "The average effective protection period that medicinal products enjoy in a country is found not to have a statistically significant effect on the level of spending on pharmaceutical R&D in that country", Copenhagen Economic Study, p. 90.
  • With regard to the objectives of the actual SPC regulation, the Max Planck Institute study also reports “that the expectation expressed by the historical lawmakers about the impact on (re)location of research centres was somewhat unrealistic from the beginning”, MPI part 1, section 2.1.5
  •  “[T]here is no evidence of illicit diversion resulting from the existence of the ‘Bolar exemption’ in the EU, which itself is a form of manufacturing waiver for clinical trials purposes (and is available during the term of both patents and SPCs”, Impact Assessment, p. 35.
  •  “[U]rgent need to tackle the specific problems faced by EU-based generics and biosimilars manufacturers”, and that “[t]his has been understood by EU’s trade partners”. Therefore, the EC concludes that “[d]oing nothing, or postponing an initiative would, firstly, further weaken the EU pharmaceutical industry”. However, according to the actual proposal, the waiver would presumably “on average, be available from 2025”, Impact Assessment, p. 76.

The European Commission provided NO evidence against but only strong support in its official studies to:

  • Introduce the “EU day-1 launch”
  • Remove anti-competitive, unjustified and unnecessary anti-diversion measures
  • Allow an immediate applicability of the SPC manufacturing waiver


  • for export only
  • with anti-diversion measures
  • applicable only to newly granted SPCs