MOEHS and SPCWaiver

MOEHS and SPCWaiver

The Moehs Ibérica group, which focuses its activity on the manufacture of Active Ingredients for the Pharmaceutical Industry, belongs to the “Medicines For Europe” association, supporting the modification of intellectual property rules in the European Union.

An active ingredient is the essential part of any medication. The pharmaceutical industry of the European Union moves between reference medicines and those known as generic medicines, which have the same active ingredients. All of them are regulated by European patent and intellectual property regulations.

What is the SPC Regulation?

The Supplementary Protection Certificates (SPC) in the EU extend the exclusivity granted by patents to the reference medicines in the European market, up to five years. SPCs are designed to compensate for the time between when a patent is applied for and authorization to market is granted, when the company has to develop its product and obtain regulatory approval.

The European context

Currently, manufacturers of generic medicines based in the EU do not have authorization to export to markets outside Europe while the reference medicine is protected by an SPC. Nor can they start manufacturing during the SPC period to prepare their launch immediately after the expiration of the SPC.

This means that the protection of the patent and the SPC grants the monopoly of manufacture and commercialization, because the production of the generic medico for its commercial use is prohibited.

This situation forces European generic manufacturers to relocate outside the EU where the SPC does not exist or has already expired, positioning itself at a competitive disadvantage.

Position of “Medicines for Europe”.

The SPC Waiver would improve access to the active ingredients and make the supply chain bigger. In this context, “Medicines for Europe” recommends the European Parliament and the Council to work with the European Commission to improve the SPC manufacturing exemption amendment and, in fact, stimulate investments with three key advantages:


  • Present the “EU Day 1 launch”, which assumes that a generic drug can be marketed the day after the expiration of the SPC.
  • Eliminate anti-competitive, unjustified and unnecessary measures.
  • Allow immediate applicability of the SPC manufacturing exemption.

The Commission’s initiative for the so-called Manufacturing Exemption SPC aims to eliminate the competitive disadvantage of generic and biosimilar manufacturers in the EU without restricting patent rights in any way.

This would have direct benefits on patients, the health budgets of the Member States and generic and biosimilar medicines.

With the approval of this regulation, the generic and biosimilar industry ensures that between 20,000 and 25,000 additional jobs would be created throughout Europe until 2025 and there would be an increase in net sales of between 7,300 and 9,500 million euros for the same period.

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