#EAPM - Dezbaterea cu privire la SPC vede Comisia și Pharma în contradicție

The European Commission’s plans on supplementary protection certificates (SPCs) waivers are ongoing, and EAPM’s members and associates need to be aware of the direction in which the EU Executive is heading, scrie Alianța Europeană pentru Personalizată Medicina (EAPM) Director Executiv Denis Horgan.

Big pharmaceutical companies are not in favour of the moves.

The Commission rolled-out a its legislative proposal to add a manufacturing waiver to SPCs as part of its upgraded Single Market Strategy in 2015. And here we are now three years later, with uncertainty.

The strategy announced that the Commission will "consult, consider and propose further measures, as appropriate, to improve the patent system in Europe, notably for pharmaceutical and other industries whose products are subject to regulated market authorisations".

It particularly explored what it called “a recalibration of certain aspects” of patent and SPC protection.

In essence, SPCs are geared towards extending patent protection for medicinal products that undergo lengthy testing and clinical trials. This all before being authorized to reach the EU’s markets.

SPCs take effect directly after a patent expires, and the Commission says that the following supplementary period can last for up to five years.

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The timeline will depend on the time needed for trials and the testing period, with the average extension standing currently at three-and-a-half years.

The base point of SPCs is to allow industry to recoup investment for research and development and, therefore, they represent at least some incentive to manufacturers, with the amount granted tripling since the early 1990s.

In two years (2020) a significant number of SPCs will have run their course, with new medical products entering the market and the Commission believes that will create new opportunities for generic medicines and biosimilars to make their mark in the health-care sector.

As mentioned, SPCs are aimed according to the Commission at rewarding investment. And while EAPM and its stakeholders are always calling for incentives to produce new treatments and medicines, these SPCs may be of great use in terms of stimulating innovation and protecting intellectual property.

But industry is less sure, because there is a downside.

SPCs can put Europe’s manufacturers at a disadvantage when weighed against non-EU based industry as, during the protection period, EU-based manufacturers of generics and/or biosimilars cannot export outside the EU to countries where SPC protection has expired or does not exist, while manufacturers based in non-EU countries can do so.

So the Commission’s 'manufacturing waiver' introduces what it calls ‘a targeted and balanced exception’ to the current system.

Companies based in Europe “will be entitled to manufacture a generic or biosimilar version of an SPC-protected medicine during the term of the certificate, if done exclusively for the purpose of exporting to a non-EU market where protection has expired or never existed”.

According to Commission figures, generic and biosimilar companies make up a growing part of the EU pharmaceutical industry,. They account for some 160,000 jobs and 350 manufacturing sites, while investing between 7% and 17% of turnover in research and development. Not huge numbers but nevertheless important.

The Commission has claimed that its proposal to add an SPC manufacturing waiver on exports will not damage innovation, although the pharmaceutical industry argues the opposite. It is designed to support small and medium generic drug companies, the Commission says.

Health Commissioner Vytenis Andriukaitis is quoted as saying that “It’s not true that it damages innovation. We have the health technology assessment to help us have innovation in our hands. It’s about possibilities to allow small and medium enterprises to produce generics and sell them to the market.”

The crux of the matter is that the generics industry has been putting on pressure for a waiver so it can start manufacturing drugs while an SPC is in place. That particular industry claims that this will bring about better access to generics.

Yet the pharmaceutical industry disagrees (notably trade group EFPIA), claiming it will actually have a negative impact on innovation, research and development, and a knock-on effect of a loss of investment in the EU.

EFPIA has said that a waiver “would be sending a concerning signal about the EU’s respect for and seriousness about building a knowledge-based economy”.

The Commission has now invited stakeholders to “provide feedback on the intended initiative and to participate effectively in future consultation activities”.

The EU Executive has asked stakeholders to provide views on the Commission's understanding of any problems and invites “possible solutions” and any relevant information on possible impacts.

EAPM, through interactive engagement with its members and stakeholders, will be actively involved in this process.