• SPC manufacturing waiver, proposed by the European Commission, in jeopardy as vested
    interests continue to hamper progress on achieving a workable draft legislation.
  • A comprehensive SPC manufacturing waiver would allow EU-based generics and biosimilars
    manufacturers to compete with those based elsewhere. Only with the inclusion of
    particularly a Day-1 launch provision, as well as the removal of anticompetitive
    requirements and immediate applicability to existing SPCs, will European patients will have
    increased access to affordable medicines
  • The waiver would create an additional 25,000 jobs, generate €9.5 billion in additional
    revenues, and reduce pressure on Member State medicines budgets
  • Medicines for Europe calls on Member State governments, Health and Industry Ministers to
    rapidly improve the legislative proposal for a manufacturing waiver and withstand efforts to
    undermine it.

There is a concrete risk that disproportionate influence on the Council of the European Union will hamper the progress of an effective, usable SPC manufacturing waiver and maintain the status quo.

Medicines for Europe, which represents the EU’s generic and biosimilar medicines industry, says that it is extremely concerned about discussions taking place at the Council which will neuter the potential benefits of the SPC manufacturing waiver.

Unfortunately, it is becoming increasingly clear that vested interests are exerting pressure on policymakers in the Council to remove clauses or add new ones that will jeopardize the whole legislation in an attempt to limit competition in unprotected markets at the expense of European competitiveness and growth.

This will lead to a loss of jobs opportunities for the EU pharmaceutical industry versus international manufacturers and increase pressure on Member States’ medicines budgets.

We urge the Council needs to reflect if it wants to back jobs for European workers, or maintain the status quo which favours delocalisation outside of the EU as is currently happening.

Proposed amendments

Despite the clear benefits of the SPC manufacturing waiver, the Council of the European Union is considering measures that will render the legislation unusable for EU based generic and biosimilar manufacturers in practice.

The European Commission presented a watered-down proposal for an SPC manufacturing waiver earlier this year. The current proposal would not allow EU-based manufacturers to prepare for day 1 launch in advance of SPC expiry in the EU, but only for export to non-EU countries where the SPC does not apply, that would not produce effect before 15-20 years from now and with the mandatory disclosure of commercially confidential information, in contrast with the existing EU rules on trade secrets and approved EMA guidance on confidential business information disclosure. The requirement to release this information to competitors (generics and/or originator) would create a unique precedent in the entire EU legislation that could go beyond the pharmaceutical sector only.

We are calling policy makers to include:

  • A clear provision for ‘Day-1 Launch’ to allow generic and biosimilar manufacturers to produce in the EU to be prepared for launch in the EU market after the SPC expiry
  • Remove the requirement for manufacturers using an SPC manufacturing waiver to undertake anticompetitive notification processes to EU intellectual property (IP) regulators, which, if left unchecked would have a significant dissuasive effect regarding the use of the manufacturing waiver. The disclosure to the SPC holder only of any commercially sensitive information would have significant dissuasive effect regarding the use of the manufacturing waiver, making the legislation effectively useless
  • An immediate application of the waiver to existing SPCs, otherwise it would negate the opportunities presented by the next significant “patent cliff” as of 2020
  • Better clarify the meaning of “maker” and “making” to ensure a coverage of all activities that would deliver fully on the expected jobs creation
  • Removing the additional, burdensome and unnecessary requirements related to the due diligence with each component of the supply chain.

Combined, these amendments would make a real difference for European healthcare systems and patients.

Commenting on proceedings, Adrian van den Hoven, Director General, Medicines for Europe, said:

“The proposal under discussion by the European Commission and the Council is going in the wrong direction to the detriment of European manufacturing jobs. It is not balanced since it is not usable by the industry that it aims to strengthen.  Only a comprehensive SPC manufacturing waiver would have clear benefits for the EU’s pharmaceutical industry, its Member State healthcare systems, and its citizens in an increasingly competitive, globalised world. The European Commission proposal should be swiftly ameliorated.

“Unfortunately, the debate, as pushed by vested interests, will effectively neuter the proposal. In fact, highly regressive revisions proposed by the Austrian Presidency will only act against the objectives of the legislative proposal and delay EU generic and biosimilar medicines entering the market. “The proposals are detrimental. If allowed to pass, the EU will lose out on over a billion euro in additional annual export revenue and tens of thousands of new, highly skilled jobs. The EU’s status as one of the world’s leading pharmaceuticals centres will diminish, the European legislative framework today does not reflect the evolution of the industry since 1992, when the SPC was introduced. Europe is a pioneer in biosimilar and other complex medicines, we should preserve and boost our excellence.

“At a time of ballooning medicines budgets across the EU, we are asking Member State governments, their health and industry ministers to carefully reflect on the benefits of a comprehensive SPC manufacturing waiver, firstly for European patient and national healthcare systems, and oppose any anti-competitive additions to this vital piece of legislation.”

The SPC manufacturing waiver

The SPC (supplementary protection certificate) allows pharmaceutical manufacturers to extend the twenty-year patent protection on their medicines by an additional five years.

While EU-based manufacturers of generic or biosimilar medicines cannot produce generic or biosimilar versions of these medicines for sale in the EU during that time, they also cannot export these medicines to countries where the SPC does not apply, nor can they produce and stockpile medicines for the EU market in advance of the day of SPC expiry.

However, the same rules do not apply to non-EU manufacturers. A biosimilar or generic manufacturer in Russia, India, the US, Canada or China can, for example, produce medicines in advance of day-1 of the EU SPC expiry. This gives them a considerable advantage on EU manufacturers, which must catch up on production, packaging and delivery.

This waiver, if applied correctly, has the potential to increase patient access to a diversified, more affordable medicines portfolio; generate an additional €9.5 billion in additional net sales; create as many as 25,000 new high-skilled jobs; keep pharmaceutical R&D and regulation in the EU; help to control growing Member State medicines budgets by increasing competition and driving down costs;