Impact on Eu Pharma

SPC MANUFACTURING WAIVER
Impact of SPC Manufacturing waiver on EU PHARMACEUTICAL SYSTEM in Europe according to European Commission

European Commission reported:

  • “Consequences [of actual SPC System]: relocation and decreasing attractiveness of the EU as a pharmaceutical hub

The problems above result in a lack of a level playing field between EU and non-EU based generic and biosimilar producers, when it comes to competing in both global markets and day-1 entry in the EU. As it will be shown below, this affects not only EU-based manufacturers of generics and biosimilars, but also EU-based originators, and even EU patients (e.g. in terms of diversified supply). Thus, the whole EU pharmaceutical ecosystem is affected.
This situation 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, as they require a proper ecosystem on top of a regulatory environment free of unintended legal barriers. This situation gives way to a number of negative consequences that will be exacerbated over time.
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, as companies will have a tendency to circumvent the current legal barriers they face, and will increasingly manufacture in third countries with weaker or no SPC protection, so as to be able to compete in global markets or be ready for day-1 entry onto the EU market.”, Impact Assessment, p. 19.

  • “Detrimental impact on the EU pharmaceutical industry as a whole, including the innovative pharmaceutical industry in the longer term:
    • Delocalisation of manufacturing capacity of medicines outside the EU might negatively affect originators investments and manufacturing in the Union, as originators often outsource production and are investing in biosimilars.
    • Loss of administrative regulatory-related skills in the EU: it is preferable that regulators be located near an advanced R&D and production ecosystem. If it is delocalised, there will be lessened impact of EU rules on the global regulatory environment, or other trade partners could even set the future regulatory rules for global markets. This would impact adversely on EU-based originators as well”, Impact Assessment, p. 20.

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

THE EUROPEAN COMMISSION PROPOSED AN SPC MANUFACTURING WAIVER:

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