Yesterday, 29th November, members of the Competitiveness Council expressed strong support for an SPC manufacturing waiver. While we regret that a couple of countries are clearly supporting vested interests in their complete opposition to the waiver, at least it is now clear that they simply working to block the constructive efforts of the rest of the Council to reposition Europe as a global hub for the production of medicines. This constructive dialogue in the Council will pave the way for future trialogue negotiations with the European Parliament where we see similar efforts toward a comprehensive manufacturing waiver.
In this technical discussion, it is important to remember the objectives of the SPC manufacturing waiver for Europe:
Medicines for Europe reiterates its request to make the SPC manufacturing waiver a success for Europe by:
Medicine’s for Europe Director General Adrian van den Hoven said “The Council and Parliament can choose to support the manufacturing of generic and biosimilar medicines in Europe over delocalisation. We trust that the European interest will prevail.”
The introduction of comprehensive SPC manufacturing waiver key to unlocking huge industrial opportunities and healthcare savings, with €90 billion of blockbuster medicines coming off patent in 2020.
The Parliament’s Health Committee (ENVI) sent a clear signal of support with the adoption of a “day one” launch possibility to supply European patients with European manufactured medicines.
The SPC manufacturing waiver aims to correct the current implementation of Supplementary Protection Certificate system which blocks manufacturers from producing generic or biosimilar medicines for export to non-EU countries where the SPC does not apply, or from producing and stockpiling these medicines to allow for ‘Day One’ launches after SPC expiry in the EU. Because of the current restrictions, the EU pharma industry is forced to delocalise production to non-EU countries, like Canada, India, China or the United States.
The Health Committee also recognised the need to protect commercially confidential information in the context of a notification procedure.
Regrettably, the Health Committee maintained the very long lead time for implementing the waiver which will delay its ability to create manufacturing and access opportunities for many years.
Commenting, Adrian van den Hoven, Director General of Medicines for Europe, said “We welcome the Health Committee’s efforts to improve the SPC manufacturing waiver in relation to day one launch and the protection of confidential business information. We hope that this progress, together with a more reasonable date of application, will be agreed by the Parliament and the Council in a future final agreement. We urge the Parliament’s Legal Committee to adopt a final Opinion that includes these important priorities for health, for jobs and for a robust pharmaceutical eco-system.”
The European Commission and OECD – Health at a Glance: Europe 2018 –recommends further use of generic and biosimilar medicines to further tackle wasteful spending in healthcare systems. The uptake of generic and biosimilar medicines varies widely across countries despite the opportunities to treat more patients and improve the sustainability of healthcare budgets. There is a need for more demand-side policies and incentives to encourage the use of generic and biosimilar medicines.
Another recent publication from the European Commission “Inequalities in access to healthcare – A study of national policies 2018” highlights that most healthcare systems need to improve equality of access to healthcare. Since 2014, spending on new originator pharmaceuticals has risen due to a wave of new medicines in areas such as hepatitis C and oncology[i],[ii].
While these treatments bring hope to patients, pharmaceutical budgets struggle to pay for high-priced innovations. This has led to short-term cost-containment measures in pharmaceuticals which are undermining the sustainability and supply of essential off-patent medicines. This has led to withdrawals of medicines and a reduction of competition in several countries[iii].
Adrian van den Hoven, Medicines for Europe Director General mentions: “Improving better and more equitable access to medicines should be prioritized in Europe. This requires pro-generic and pro-biosimilar medicines policies based on healthy competition. Cutting spending on essential medicines to pay for high priced new medicines is a recipe for poorer access to medicines for Europeans.”
[i] Hello, $200B: Super-pricey new cancer drugs drive mega increases in treatment spending – https://www.fiercepharma.com/pharma/as-cancer-treatment-becomes-more-targeted-global-costs-are-heading-to-200b-report
[ii] IQVIA – Global Oncology Trends 2018 Innovation, Expansion and Disruption; https://www.iqvia.com/institute/reports/global-oncology-trends-2018
[iii] Medicines for Europe Reading List on Medicines’ shortages – https://www.medicinesforeurope.com/docs/20170927%20-%20Medicine%20shortages%20-%20Reading%20list_final.pdf
The 2nd Value Added Medicines conference gathered a wide range of experts in the healthcare community to raise awareness, inform and debate with the mutual intention to present solutions for maximising the benefits of and encouraging the development of continuous innovation. Adjustments in the healthcare processes – eg. adjustments on purchasing/procurement processes, acceptance of adequate evidence and, where needed, adjustment of pricing and reimbursement barriers – , as well as seizing the benefits of digital technologies and increased stakeholder collaboration should be maximised to bring value added medicines to patients.
Marc-Alexander Mahl, Medicines for Europe President, highlighted that “Today’s event brought stakeholders who care about patient access to medicines together to reflect on the role of continuous innovation to deliver efficient and sustainable solutions to patient needs. Value added medicines deliver patient-centred gains from both the clinical and economic perspective. To capture this innovation, we have to integrate value added medicines in healthcare systems and seize opportunities in digital healthcare. Stakeholder collaboration will be key to fully ensure these benefits reach patients and the healthcare community and society”.
The Value Added Medicines Sector Group also awarded two prizes for outstanding programmes which improve patient quality of life and/or adherence and/or demonstrate relevant value added benefits on existing treatments. Congratulations to our winners 2018:
Category 1 – ‘Be Educated and Empowered Patient (BEEP) Program’ – Education program for organ transplanted patients organised by The Hungarian Transplant Federation
Category 2 – ‘Keramod® Gel’ – an innovative 5% Imiquimod film-forming formulation to enhance patient´s compliance by reducing side effects developed by Laboratorios Ojer Pharma
More information about the prize winners will be available in the coming weeks. Please visit https://www.medicinesforeurope.com/value-added-medicines/ for more information.
Medicines for Europe is glad to announce the occasion of the first European Open Industry Day in Romania, which took place in Bucharest on October 31st. The objective of the day was to open up our industry’s doors to interested institutional stakeholders.
This initiative has been designed together with APMGR, the Romanian generic association, and Zentiva, who hosted the initiative, to showcase the strength of Europe’s local and regional pharmaceutical excellence.
“Our goal is to provide insight into the workings of pharmaceutical plants, showing the high-level standards of safety and quality of the generic, biosimilar and value-added medicines manufacturing chain and above all showing the end result of these processes – life enhancing, lifesaving medicines and products” said Sergio Napolitano, Director for Legal and External Affairs.
For the stakeholders present, debate and discussion focused on the key challenges we currently face in terms of market and industrial sustainability and seek to explore the opportunities for further growth in the sector. This was particularly pertinent in view of the upcoming Romanian Presidency of the Council of the European Union.
It is essential that Europe will maintain its primary role as a pharmaceutical hub for European patients by guaranteeing universal and timely access medicines. To ensure this, European generic and biosimilar medicines play a key role. IMS has calculated that between 2005 and 2015, across seven disease areas, twice as many patients have been treated without any impact on treatment costs.
Europe cannot rely anymore on third party manufacturers, it is of great importance to introduce a comprehensive SPC manufacturing waiver which supports greater patient access to medicines. This waiver would permit pharmaceutical companies to begin manufacturing medicines for export to non-EU countries during the SPC period as well as allowing these companies to be ready to supply in Europe on day 1 after patent expiry.
A comprehensive SPC manufacturing waiver would reduce these barriers and encourage a level playing field, both within the EU and on a global scale. Furthermore, the waiver will provide vast benefits to patients and EU healthcare services, including faster access to a more diversified medicines supply, a more cost-efficient medicines budget due to increased competition, and a guarantee of EU-quality generic and biosimilar medicines.
The continued development of local pharmaceutical manufacturing is essential to deliver results at the pan-European level – maintaining the EU’s position as a leader on the global stage.
For more information on the SPC manufacturing waiver, please visit http://www.spcwaiver.com/en/
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
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