Impact on European Patients

Impact of SPC Manufacturing waiver on PATIENTS ACCESS & NATIONAL PUBLIC HEALTHCARE EXPENDITURE 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.
  • Patients in a certain Member States were not able to access to certain treatments until a biosimilar is available. Therefore, limiting the day-1 entry capacity for EU biosimilars in those Member States could make a difference for some EU patients”, Impact Assessment, p.23.
  • Reduced competition affects access to medicines for EU patients and health expenditure for EU public budgets. […] Reduced competition may lead to price increases.”, Impact Assessment, p. 22.
  • “We do not find evidence that the SPC has supported the objective of better accessibility and diffusion of innovative products across the internal market”, Copenhagen Economics p. 178.
  • “…later entry of generic medicinal products pushes up total expenditure on medicinal products (…)”, Copenhagen Economics p. 15.
  • Patients […] would enjoy additional sources of supply of medicines with this stockpiling waiver”, Impact Assessment, p. 41.
  • Security of supply” and risks of “episodes of shortagesrequire an SPC manufacturing waiver “The increased dependency on non-EU sources has already led to concerns with regard to maintaining security and quality of supply in the EU, Impact Assessment, p.22.
  • Citizens “care about the origin of the production of the medicines they consume”, Impact Assessment, p. 22.With “a stockpiling-only waiver [..] it could tackle […]the concerns expressed by some public authorities and citizens about over-reliance of imported medicines”, Impact Assessment, p. 41.
  • Relocation of clinical trials may also be detrimental to certain groups of patients, as [they…] benefit from experimental medicines”, Impact Assessment, p. 22.
  • Patients and doctors favoured an SPC manufacturing waiver on the ground that it would promote early competition in the market, and thus more affordable medicines”, Impact Assessment, p. 37.
  • An SPC waiver for stockpiling purposes would result in savings on pharmaceutical expenditure from this earlier competition and therefore lead to a speedier reduction of prices in Member States upon expiry of the SPC”, Impact Assessment, p. 41.
  • In the comparison of the impacts of policy options (Impact Assessment, pp. 46, 47):
    • With an SPC manufacturing waiver for EXPORT only, patients “would enjoy some improvement in better timely access to generics/biosimilars of high EU-made quality, and therefore a more diversified source of supply”. “Additional savings to public spending […] of the order of upwards of 4%” (p. 12 of the Proposal)
    • With an SPC manufacturing waiver for STOCKPILING, “the stockpiling feature would bring additional time gains for timely access in the EU day-1, and a more diversified source of supply
    •  With an SPC manufacturing waiver for EXPORT & STOCKPILING, the impacts of previous options “would be cumulative”. “Estimated savings on public health budgets expenditure on pharmaceuticals of up to 8%”.


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