Impact on European SMEs

Impact of SPC Manufacturing waiver on SMEs 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 is “particularly detrimental for small and medium-sized EU pharmaceutical companies, since they rarely possess manufacturing facilities in ‘non-SPC’ third countries. The creation and growth of EU-based start-ups is also affected […] This situation gives way to a number of negative consequences that will be exacerbated over time”, Impact Assessment, p. 19.
  • Today, significant innovation comes from specialised SMEs focused on the initial steps of R&D and development, with less than 25% of the new medicines being developed by originators(p. 12). “…over the past decade, 60% of innovator small molecules and 82% of innovator biologics have their roots outside big pharmaceutical company”, Impact Assessment, p. 12.
  •  “[V]ast majority of SMEs […] supports the introduction of a waiver in the EU, and considers that the longer duration of SPCs in the Union compared to non-EU countries makes manufacturing in the Union less interesting for them”, Impact Assessment, p. 36.
  • “The cost of anti-diversion measures would be negligible for major manufacturers, but it could have a more significant impact on SMEs”, Impact Assessment, p. 39. “[It] should take account of potentially dissuasive costs for SMEs (additional operational costs (e.g. labelling), the need to contract specialised attorneys (e.g. for potentially complex notification procedures, and court proceedings)”, Impact Assessment, 42.
  • There is no evidence of illicit diversion resulting from the existence of the ‘Bolar exemption’ in the EU, which itself if a form of manufacturing waiver for clinical trials purposes (and is available during the term of both patents and SPCs)”, Impact Assessment, p. 35.
  •  “40% of the SMEs manufacturers of medicines in the EU (1 362 firms) who are currently exporting outside the EU will directly benefit from this measure” p. 106. [It] “would be especially beneficial for EU SMEs manufacturing generics or developing biosimilars, because they do not necessarily have access to the necessary funding or skills to outsource or delocalise production outside the EU”, Impact Assessment, p. 42.
  • “For SME manufacturers […] a stockpiling waiver would assist in scaling up production to be ready for timely entry into domestic or to other Member State market upon SPC expiry”, Impact Assessment, p. 106.
  •  The Max Planck Institute study confirms thatneither the production for export, nor the production for stockpiling purposes run counter to the legal objectives of the SPC system”, and “arguably the only effect of prohibiting stockpiling would be to boost the business opportunities of non-EU companies to the disadvantage of generic manufacturers established here.”, MPI part 3, section

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