Access to generic and biosimilar medicines can be improved with coherent proposals for IP and pharmaceutical reform in Europe that encourage Day 1 launch.

This has been echoed in the recent European Parliament report, which supports finetuning the IP system towards higher quality and timely access to generic and biosimilar medicines.

This includes the timely evaluation of the SPC manufacturing waiver that entered into force in July 2019 and is expected to start producing effects in the second half of 2022. The industry takes very seriously the review that the Commission is going to conduct in 2024 to assess whether the limitations and conditions introduced in the legislation effectively allow companies to achieve the stated objectives.

“Unjustified delays to generic and biosimilar competition after IP expiry are against the objectives of the current pharmaceutical reform and do not reflect the fundamental principles according to which the pharmaceutical system is designed in Europe“, said Sergio Napolitano, General Counsel at Medicines for Europe. “For this reason, it is finally time to ban patent linkage in Europe, give effect to the long-standing objective to enlarge the Bolar exemption and tackle the misuses of divisional patents that unduly extend monopolies and delay access to generic and biosimilar medicines“

These issues will be discussed by representatives of Medicines for Europe, the European Commission and the European Patent Office at a webinar on 16 November. For more information, see here https://www.medicinesforeurope.com/events/lac21/

Medicines for Europe

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 directly employ 190,000 people at over 400 manufacturing and 126 R&D sites in Europe and invest up to 17% of their turnover in R&D investment. 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 European Parliament Own Initiative Report on an intellectual property action plan is an important step to support the EU’s recovery and resilience following the pandemic and on equitable access to medicine.

The report outlines critical policies to address weaknesses in the current system such as

Stopping abuses of divisional patent applications that artificially extend the enforceable life of patents and block timely access to generic and biosimilar medicines.
Banning patent linkages in Europe that systematically delay generic and biosimilar market entry by linking regulatory decisions to the existence of civil patent rights. This is incompatible with the rationale of the EU pharmaceutical system.
Revising the Bolar exemption, to allow immediate generic and biosimilar market entry at IP expiry.
Assessing the impact of a unitary supplementary protection certificate on timely competition from generic and biosimilar entry. This is clearly driven by the need to ensure that new IP mechanisms do not undermine equitable access to medicine in Europe and that IP titles (and their regulatory extensions) are granted in a transparent and accountable way.

“The European Parliament has clearly voted for a strong and fair IP system by underlining the importance of timely generic and biosimilar medicine competition. The misuse of divisional patents, the need to enlarge the scope of bolar to include API and all regulatory and administrative steps, and the long overdue ban anti-competitive patent linkage are well known problems that the Commission should address in the IP Action Plan. The Parliament has voted; the Commission must act.”, said Adrian van den Hoven, Director General at Medicines for Europe.

Medicines for Europe

Innovation on existing, well-known molecules through repurposing can deliver huge benefits for patients and address unmet medical needs sustainably. Today the European Commission Safe and Timely Access to Medicines for Patients (STAMP) expert group, established in 2015 has launched a project to assist bringing value added repurposing to life.

Repurposing has shown its value during COVID-19, where existing medicines were used to treat very sick patients. Repurposing, likely in combination with important medicines reformulation, has huge potential to treat rare diseases and cancers.

The STAMP pilot project will connect academic researchers with medicine regulatory agencies for early scientific advice on repurposing projects. This will be instrumental to generate a robust data package to translate research into to medicines access for patients.

This pilot project is a great first step to support clinical research projects on existing molecules and it must become a part of a broader sustainable innovation ecosystem for off-patent medicine. To translate clinical research into access to medicines, there should be quick and simple regulatory steps to allow pharmaceutical manufacturers to bring new indications on label and to facilitate patient-centric design for new treatments. This may include reformulation, new strengths or adaptation for specific patient groups (i.e. paediatric populations). These investments must also be recognised in pricing and reimbursement policies to make access a reality for all patients.

 Medicines for Europe is a dedicated partner in the STAMP expert group and will facilitate the cooperation between researchers and pharmaceutical manufacturers.

For more information on the work of the STAMP expert group, see https://ec.europa.eu/health/documents/pharmaceutical-committee/stamp_en

For more information on the pilot project, see https://www.ema.europa.eu/en/news/repurposing-authorised-medicines-pilot-support-not-profit-organisations-academia

Medicines for Europe

Rebecca Guntern (Sandoz) today begins an interim term as President of Medicines for Europe for a period of 3 months, as Christoph Stoller (Teva) steps down following his two-year mandate.

Christoph Stoller led the industry through the most challenging health care crisis in generations. Our industry coordinated with the EU to prevent shortages of emergency hospital medicines and to maintain the supply of essential medicines across Europe, at a time of unprecedented demand in the early phase of the pandemic.

As our companies scaled up production output by up to 900%, the association worked with the EU to reopen borders for the EU manufacturing supply chain, drive regulatory flexibility across borders while maintaining EU standards, and ensure full functioning of our factories for medicines supply during the pandemic. Christoph also helped the industry to prepare for the major upcoming review of EU pharmaceutical legislation, notably by leading discussions about manufacturing resilience and tackling the economic root causes of shortages. Christoph strongly encouraged the setup of the EU Structured Dialogue on Supply Security and Manufacturing.

Rebecca Guntern takes over following her two-year tenure as Vice-President of the association, during which time she has led on a range of initiatives, particularly improving patient access to biosimilar medicines and guiding the EU Structured Dialogue on resilient supply chains. She will lead the association until the Board can formally elect a new President in the New Year.

Commenting on the end of his term, Christoph Stoller said: “When I began my mandate as President of Medicines for Europe, I could never have known what awaited us with the outbreak of COVID-19. The industry mobilised like never before to deliver medicines despite huge spikes in demand. It was my privilege to lead the association during that time and I am very proud of what we achieved together, to avoid major shortages of essential ICU medicines in Europe and to secure continuous access to medicines for millions of European patients. I leave Medicines for Europe in the best of hands with Rebecca at the helm.”

Beginning her term, Rebecca Guntern said: “The pandemic has shaken our industry and our society to the core and revealed some clear gaps from the policy perspective. Beginning my term, I am looking forward to leading Medicines for Europe with a clear focus on flexible, pragmatic and patient-centric policies that will enable our industry to continue as the principal provider of life-saving medicines to patients in Europe.”

Medicines for Europe

Medicines For Europe strongly supports the EU’s drive to learn from COVID-19 and to improve its crisis preparedness and response. The proposal to establish a European Health Emergency Preparedness and Response Authority (HERA) is an important contribution to that policy and we support its creation and will contribute to its work for the security of all Europeans.

Having been at the front lines of the COVID-19 pandemic, supplying critical medicines in a crisis, we acknowledge the efforts of the European Commission and the need for more efficient policies to manage future crises.

HERA will need to be an efficient agency with strong links to healthcare industries, including Medicines for Europe.

A successful HERA must:

Ensure coordination between manufacturing associations & EU authorities via the joint industrial cooperation forum

Make sure EU regulations are adjusted to prioritise supply of essential medicines
Eliminate the proposal for redundant manufacturing capacity

It is not possible to predict which medicines will be needed in a future crisis and maintaining redundant manufacturing capacity is neither feasible nor a good use of taxpayer money. Instead, pharmaceutical policy should encourage the sustainability of manufacturing investment in a wide range of medicine production types as outlined in the Structured Dialogue.
In a crisis, regulatory flexibility and competition law adaptations are more successful tools to enable manufacturers to respond to surges in demand for medicines.

Include provisions for efficient strategic reserves of medicines that factor in waste and costly destruction that should be avoided. Reserve policies must be coherent and avoid distorting supplies of medicines to certain (smaller) EU countries.

Overcome the significant regulatory differences applied by Member States to most emergency (nationally licenced) medicines which limits the possibility to allocate stock efficiently in a crisis.
Digitalise the sector and its regulatory systems. This includes putting order on to existing digital health initiatives.

Dysfunctional joint procurement policy must change

The European Commission must correct the joint procurement system before using it for HERA. Most importantly:

Joint procurement should not create distortions into the internal market.
Provide accurate demand estimates with clear volume commitments in joint tenders.
Should operate only under an exclusivity principle where participating countries commit to source their supplies from the winners of the joint procurement procedure.
Be able to efficiently and swiftly contract awarded suppliers and provide clear timelines and specifications for delivery of purchased goods.
Be more transparent with the possibility for industry to comment on tender criteria and the obligation for the Commission to clarify that criteria publicly and to reply to individual queries from companies in a timely manner.

Medicines for Europe

Legislative reforms aligned with current off-patent market conditions are the precondition for a coherent policy to improve the secure supply of essential medicines. The EU structured dialogue on medicines manufacturing is a critical first step to align stakeholders on workable reforms.

As the biggest supplier of prescription medicines, our industry is committed to improving security of supply in Europe.

for security of supply, legislative reform should cover:

Up-to-date European regulation based on interconnected digital tools to improve the predictability of supply and demand on the EU market.
Alignment of Member States on security of supply based on EU solidarity – notably on what are critical products, to reward companies for investments in supply chain resilience, notably by introducing smart multi criteria tenders, and to prevent distortive national stockpiling requirements.
Restore European leadership in manufacturing by adapting state aid rules to enable the generic medicines and API industry to participate in national Recovery and Resilience plans for green and digital technology investments.

Speaking at the EU Structured Dialogue, Medicines for Europe President, Christoph Stoller (TEVA) outlined ““Pharmaceutical and industrial policy, must be an enabler for robust supply chains and support our industry efforts to mitigate and address the root causes of supply chain vulnerabilities, while ultimately supporting more investments in European manufacturing. The urgency is to agree and implement smart regulatory and economic policies! In the off patent sector, the race to the lowest price has reached its limit. And rather than punishing companies via penalties or by implementing distortive national requirements such as stockpiling, we should think win win”.

Medicines for Europe Vice President Rebecca Guntern (Sandoz) said: “We need to jointly design a coherent policy to ensure security of supply for essential medicines, which is better aligned with the prevailing market conditions for off-patent medicines. Medicine manufacturing costs cannot be compressed indefinitely. We need policies that enable a meaningful digital framework, promote flexible regulatory systems and phase out unhelpful and short-sighted cost-containment measures”.

Medicines for Europe

The newly launched update of the industrial strategy aims to support Europe’s recovery and boost open strategic manufacturing in Europe. With COVID-19 still a threat, Europe’s economic health and global interdependence requires attention. Few sectors could be considered more strategic than healthcare.

Medicines for Europe members supply and manufacture the majority of emergency medicines (70-90% of ICU medicines), anti-infective medicines and chronic care medicines, widely used to treat cancer, cardiac conditions, infectious and respiratory diseases including COVID-19. Essential medicines are produced in over 400 manufacturing sites across Europe. Yet the sector operates under cost-containment policies by member states and has consolidated over time.

While Europe remains a major global manufacturer of active pharmaceutical ingredients (API) and on complex medicine production processes[1], the reality is that India and China are growing their production at a much faster rate. India and China are also pursuing robust industrial strategies to encourage an expansion of medicines production in their territories. The COVID-19 pandemic underlined the critical importance of robust medicines manufacturing capabilities and should encourage the EU to pursue a smart industrial strategy for pharmaceutical production including:

Coordination with relevant stakeholders: the structured dialogue on pharmaceutical manufacturing will identify the strengths and weaknesses and strengths of pharmaceutical supply chains and will propose policy reforms to incentivize investments in manufacturing and robust supply chains.
Smart market policies: The EU market for generic medicines must be reformed. Cost-containment reimbursement measures and procurement policies do not encourage investment in manufacturing and supply chain resilience. This has been recognised in the Pharmaceutical Strategy for Europe and it must be implemented with real requirements for policies that look beyond the lowest price only and encourage security criteria, such as support multiple suppliers and the green transition.
Digital transformation in the regulatory network: regulatory processes must be digitalised and medicine agencies interconnected to improve the efficiency of regulatory procedures. This has obvious benefits including more effective prevention of shortages and over-consolidation.
Targeted Funds: NextGenerationEU recovery instruments should support medicines manufacturing as a key strategic pillar for Europe to boost secure and resilient supplies. This should include clear measures to provide grants for investments in manufacturing in Europe and to review EU state aid requirements to take account of the security of supply.

Medicines for Europe President, Christoph Stoller (TEVA) said: “It is painful to see Europe gradually losing its essential pharmaceutical production. This cannot continue. The EU industrial strategy published last week is an important first step to slow this process but tailored actions for the healthcare industry are needed. The EU has set up important initiatives to move in this direction, such as the EU structured dialogue on medicines manufacturing. We need a robust manufacturing policy focusing on critical manufacturing technologies to strengthen EU resilience and deliver equitable access to medicines. but we would like to see this reflected across European Commission directorates. Medicines for Europe will engage constructively to achieve this goal together, supporting the security of supply of medicines.”

Medicines for Europe

[1] European Commission staff working document, page 136

The EU must stop the offshoring of essential medicines manufacturing investments

Adjustments to IP framework needed to improve access to medicines in Europe

Access to medicines critical in European Parliament vote on EU IP action plan

Medicines for Europe

European Commission pilot project on repurposing brings value added innovation to life

Smart use of off-patent medicines will be critical to rebuild healthcare systems successfully post-Covid

Baton passes from Christoph Stoller to Rebecca Guntern as President of Medicines for Europe

Medicines for Europe

HERA must address outstanding weaknesses in EU pharma framework to be successful

Medicines for Europe

EU must take the lead to ensure security of supply for medicines

Medicines for Europe

Open borders that prioritise essential goods key to medicines supply in Europe

EU Industrial strategy should be key to improving medicines supply chains

Medicines for Europe

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