The US patent and trademark office (USPTO), together with the US Trade Office (USTR) and the US Department of Commerce, is holding this week a dedicated, Government official only briefing on the EU legislative proposal for a Supplementary Protection Certificate (SPC) manufacturing waiver. The meeting, which will be conducted under Chatham house rules, will take Tuesday, October 23rd in Brussels.
The aim of the meeting is to convey the position of the US commercial bodies and representatives to EU officials on the introduction of an SPC manufacturing waiver in Europe, and influence the outcome of this EU legislative proposal. This is in line with consistent efforts from US commercial interests to close the US healthcare market to biosimilar medicines. Unfortunately the organisers have had no regard for transparency about the details of the meeting, the participants, nor the agenda.
As has been highlighted by numerous independent studies on the matter, the introduction of an SPC manufacturing waiver in Europe, if done so correctly, can deliver vast benefits for patients, EU healthcare budgets and investments in manufacturing of medicines.
The US is interfering in an EU domestic policy matter by trying to manipulate and influence the current debate, in order to defend non-better-specified interests.
Commenting on the meeting, Adrian van den Hoven, Director General at Medicines for Europe stated “We are surprised to hear that the US is openly interfering in an EU domestic affair in an extremely delicate moment of the legislative process on the SPC manufacturing waiver. The EU, as an entity of 28 sovereign Member States, does not need and cannot accept such external pressure, let alone when it comes to the health of patients and investments in medicines development. Europe cannot be intimidated and will not capitulate before the defence of the economic concerns of US commercial interests!“
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:
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;
An English Court has determined that the contested supplementary protection certificate (SPC) on Truvada® held by Gilead is invalid by applying the criteria laid down by a recent referral to the Court of Justice of the EU (CJEU). Mr Justice Arnold held that Gilead’s SPC failed the CJEU’s test as Gilead’s basic patent on which the SPC was based did not describe the combination of tenofovir and emtricitabine and did not specifically identify emtricitabine.
This judgment applying the CJEU decision should now assist in the resolution of a number of parallel cases in national courts across Europe.
Of course, this ruling will have a very meaningful impact on the HIV patient community and those at risk of contracting HIV, who could not afford the monthly 355GBP treatment cost of Truvada®. This ruling is a major first step in ensuring timely and appropriate generic competition that ultimately will increase patient access to this vital medicine, bring society a huge leap forward in combatting HIV, and contribute to healthcare system sustainability.
“This decision is a step forward in ensuring certainty and quality of the patent and SPC systems, and sets the stage for rapid court decisions to invalidate this SPC across Europe to enable greater access to this important HIV therapy.” Adrian van den Hoven
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Medicines for Europe welcomes the European Parliament’s Committee on Environment, Public Health and Food Safety’s (‘ENVI’) support for an SPC manufacturing waiver.
ENVI voiced its support in its Draft Opinion on the proposal which was published by the Committee on 13 September last.
The ENVI Committee Rapporteur, MEP Tiemo Wölken (S&D, Germany), welcomed the proposal to amend Regulation (EC) No 469/2009 which provides a supplementary protection to medicinal products. Mr. Wölken acknowledged that the amendment proposal was in line with the European Parliament’s commitment to improve access to medicines for patients.
Currently, as a result of the existing SPC regulation, EU-based generic and biosimilar medicine manufactures face restrictions which limit their capacity to manufacture and export to countries outside the EU where no SPC applies. This places these companies at a competitive disadvantage to those outside of the EU.
The existing manufacturing restriction also denies European patients access to more affordable medicines from the first day on which the SPC expires, due to the long lead-in times required to produce medicines.
Mr. Wölken acknowledged the need to “restore the level playing field between EU-based generic and biosimilar manufacturers and non-EU based ones, boosting the competitiveness of EU manufacturers….as well as facilitating Day-1 entry within the Union.”
He also pointed to the need to “reduce barriers to access to medicines”, noting that “producing within the EU can lead to enhanced security and quality of supply, reduced counterfeits and uncertainty due to import reliance”.
Medicines for Europe Director General Adrian van den Hoven welcomed the draft opinion of ENVI, stating:
“ENVI’s draft opinion is a significant one. It ensures that the introduction of an SPC manufacturing waiver now moves a step closer to being realised. The extensive consideration given to this proposal by ENVI, including its Rapporteur MEP Tiemo Wölken and others such as MEP Cabezon Ruiz (S&D, Spain), must be acknowledged. ENVI’s amendments to the Commission’s original proposal, including the need for Day-1 launch and the removal of the disclosure of some commercially sensitive information enhance the proposal further. At the same time, some additional improvements to the proposal can be achieved, especially with regard to the need for applying the SPC manufacturing waiver as soon as possible in order for it to serve the purposes it is meant for, as well as making sure that the system can function, notably getting rid of the disclosure of all of the commercially sensitive and confidential information within the notification requirement.
“ENVI recognises the important, and much needed, reforms which this proposal will deliver for European patients and for the competitiveness of European pharmaceutical manufacturers. The Committee’s Draft Opinion acknowledges the SPC waiver’s key public health benefits – faster access to affordable medicines, enhanced security and quality of supply, improved competitiveness for EU-based generic and biosimilar manufacturers, whilst reinforcing the EU’s position as a hub for pharma innovation and manufacturing.
ENVI have been unequivocal in their support of this proposal in the past, and MEP Tiemo Wölken has confirmed this in its Draft Opinion. Medicines for Europe now urges the other ENVI rapporteurs and European Parliament committees, JURI and INTA, as well as the other policymakers – at national and European level – to support this line and prioritise the introduction of this proposal”, added Mr. van den Hoven.
ENDS.
Note for editors
A comprehensive and workable SPC manufacturing waiver will generate huge opportunities for Europe as highlighted in the Charles Rivers Associates study – the only independent study on this issue commissioned and published by the European Commission:
Link to ENVI draft opinion: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-%2f%2fEP%2f%2fNONSGML%2bCOMPARL%2bPE-627.040%2b01%2bDOC%2bPDF%2bV0%2f%2fEN
Definitions
Medicines for Europe is committed to bringing accessible, high quality medicines to patients across Europe. Already today our industry supplies 63% of dispensed medicines in Europe.
As part of our commitment to improve public health, Medicines for Europe and its members regularly engage and collaborate with the stakeholder community, including healthcare professionals and patient representatives. This enables us to deliver accessible healthcare solutions that work best for our stakeholders, and ultimately contribute to the sustainability of healthcare systems across Europe. Disclosure of transfers of value related to these interactions enables the industry, healthcare professionals and patient organisations to jointly promote shared values of transparency, integrity, accountability and collaboration.
All Medicines for Europe corporate members, including the corporate members of our national associations, are required to disclose according to the trade association Code of Conduct. Where national legislation or rules already require this, companies must follow the law of the specific Member State and of the Medicines for Europe code (in cases where our rules are stricter).
In accordance with the Medicines for Europe Code of Conduct, disclosure is to be made on an annual basis and each reporting period covers the previous calendar year. The first reporting period is calendar year 2017, with disclosures published by June 30, 2018. The information will be published on the website of each member and will be accessible to the public. Where disclosure is made through a national authority database, the information will be available on that authority’s website.
The Medicines for Europe Code of Conduct and information on the disclosure by our association are available on our website.
The joint 24th Medicines for Europe and 21st IGBA Annual Conference began today with key industry leaders coming together in Budapest, Hungary, to discuss the challenges and opportunities for the global generic, biosimilar and value added medicines industries.
Challenges related to industry sustainability were debated with key experts, who shared perspectives on topics such as medicines shortages, use of data, Brexit, international regulatory cooperation and the EU Falsified Medicines Directive (FMD). European industry leaders outlined the period of intense preparations to ensure compliance by the early 2019-milestones for FMD and Brexit.
The conference also underlined the exciting opportunities ahead for the industry. Having welcomed the European Commission legislative proposal for an EU SPC manufacturing waiver in May this year, Medicines for Europe is committed to supporting such industrial policy initiatives which can strengthen the European industrial base, increasing investments in R&D for biosimilar medicines, boosting EU competitiveness, and delivering faster access to medicines for patients.
Marc Alexander Mahl, President of Medicines for Europe, commented that “Medicines for Europe is committed to engaging with stakeholders and decision makers to improve patient access. In fact, to showcase our strong manufacturing footprint in Europe, Medicines for Europe has decided to launch an ‘Industry manufacturing week’, in which member companies will open production plants across Europe for stakeholders. We are leading suppliers of medicines for European patients and we want to engage with local communities to show that we are an integral part of the health ecosystem. “
David Gaugh, Chair of IGBA and Senior Vice President at the Association for Accessible Medicines, USA, commented that “the global perspective of the industry is crucial; key objectives such as international regulatory harmonisation and global collaboration to ensure the uptake of generic, biosimilar and value-added medicines can bring real benefits to patients – access and affordability are objectives we all share, right across the globe.”
Mr László György, State Secretary for Economic Strategy and Regulation, stated that “the primary goal of the newly established Ministry of Innovation and Technology is to maintain and improve decent living conditions and enhance the competitiveness of the pharmaceutical industry, which plays a decisive role in the Hungarian economy.”
Medicines for Europe represents the generic, biosimilar and value added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members employ 160,000 people at over 350 manufacturing and R&D sites in Europe, and invest up to 17% of their turnover in medical innovation. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU.
The International Generic and Biosimilar Medicines Association (IGBA) was founded as IGPA (International Generic Pharmaceutical Alliance) in March 1997 to strengthen cooperation between associations representing manufacturers of generic medicines from around the world. Its membership includes AAM (USA), CGPA (Canada), GBM – Southern Africa (South Africa), IPA (India), JAPM (Jordan), JGA (Japan), Medicines for Europe (Europe), and TGPA (Taiwan), while the associations from Australia (GBMA), Brazil (ProGenericos), Mexico (AMEGI), and Malaysia (MOPI) are Associate Members. The IGBA is at the forefront of preserving sustainable competition within our industry, by stimulating competitiveness and innovation in the pharmaceutical sector; thereby, ensuring millions of patients around the world have access to high quality, pro-competitive medicines. Through its constituent member associations, the IGBA maintains constant dialogue with government authorities around the world, as well as with international institutions such as WTO, WIPO and WHO. More information: www.igbamedicines.org
Nonetheless, we are concerned that the legislative proposal does not fully address the unintended effects of the SPC Regulation, specifically production for ‘day 1 launch’ in Europe after SPC expiry, as was clearly announced in the European Commission Single Market Strategy for Europe in 2015. The Commission published the Charles River Associates (CRA) study which showed the importance of allowing generic and biosimilar manufacturers to prepare for launch in Europe at SPC expiry – with thousands of manufacturing jobs and lower national government drugs bills at stake (see addendum below). This is underlined in the Explanatory Memorandum of today’s proposal which surprisingly is not included the draft legislative amendment. The draft also contains a few anomalies that undermine its stated intentions and give limited practical effect to the amendment for SMEs which hope to benefit from this opportunity.
In multiple reports and resolutions, the European Parliament has called on the European Commission to introduce a comprehensive SPC manufacturing waiver, covering both export and ‘day 1 launch’, to level the playing field between European and non-EU manufacturers.
Legislators (Parliament and Council) now have the possibility of improving the Commission proposal by including manufacturing for ‘day 1 launch’ and correcting the anomalies that limit its effective use for SMEs. Only a comprehensive and usable SPC manufacturing waiver would address the unintended effect of the SPC regulation that has forced European generic and biosimilar manufacturers to delocalise manufacturing outside the EU.
Marc Alexander Mahl, President of Medicines for Europe commented that “the launch of the SPC manufacturing waiver legislative proposal is a very positive step to create manufacturing jobs in Europe, and to boost competitiveness by allowing EU companies to compete on a level playing field. However, this proposal should allow companies – especially SMEs – to prepare for ‘day 1 launch’ after expiry in Europe. Without this, European patients will not get timely access to European manufactured generic and biosimilar medicines.
For products with large investments in development and manufacturing infrastructure, like biosimilar medicines, EU `day 1 launch´ capability is a key criteria for localisation in Europe. Imported biosimilar and complex medicines from non-SPC markets will be available on ‘day 1’, while EU-based manufacturers would be specifically blocked from competing in the critical phase of market formation.
Our call now is on the European Parliament and Council to rapidly adopt the proposal with the right to produce for launch in Europe, which will increase access to medicines for patients, lower drug costs for national health budgets and benefit a dynamic European industry.
We have also gathered the key documents and resources pertaining to the SPC manufacturing waiver on the newly-launched website www.spcwaiver.com. This website aims to gather concrete and legitimate information about current SPC protection and the complete SPC manufacturing waiver for medicinal products in the EU and its consequences, as well as appropriate ways to strengthen the European economy.”
Medicines for Europe represents the generic, biosimilar and value added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. For more information please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU. For information on the SPC manufacturing waiver, please see www.spcwaiver.com.
A comprehensive and workable SPC manufacturing waiver will generate huge opportunities for Europe as highlighted in the Charles Rivers Associates study – the only independent study on this issue commissioned and published by the European Commission: