Christoph Stoller (Teva) Appointed as new President of Medicines for Europe
Immediately calls on new President of EU Commission to prioritise Healthcare

  • Christoph  Stoller  (General  Manager  Germany/Austria  for  Teva  Pharmaceuticals)  announced as President of Medicines for Europe for a two-year mandate
  • Priority to address the issue of essential medicines shortages across Europe
  • First action to call on newly appointed President of European Commission Ursula von der Leyen to establish a new pharmaceutical forum focused on sustainable access to medicines for all EU citizens

Christoph Stoller was elected as President of Medicines for Europe today for a 2 year period.

Christoph is currently General Manager for Teva Germany and Austria, and has taken an active role on the Medicines for Europe Board over the last 5 years.

To mark the launch of his Presidency, Christoph outlined four key priorities for his two year mandate:

  • Driving the use of high quality generic, biosimilar and value added medicines to ensure equitable and sustainable access to medicines ;
  • Addressing supply chain vulnerabilities and tackling the economic root causes of medicines shortages ;
  • Innovating in  digital  healthcare,  which  will  unquestionably  bring  additional  significant  benefits  to patients and healthcare systems ;
  • Continue to progress industry commitment and investment to minimize environmental impact,

Director General of Medicines for Europe, Adrian Van Den Hoven, commented: “With over 25 years of industry experience and a true passion for healthcare, Christoph will continue to drive the industry on sustainable access to medicines for patients. Over the last 10 years our industry has doubled access to medicines for patients with diabetes and cardiac conditions and increased the quality of life for a huge number of patients with chronic conditions.  Christoph’s leadership will help our industry accelerate this trend.”

Speaking at the launch of his Presidency, Christoph commented: “With our companies providing 67% of dispensed medicines in Europe, there has never been a more important time for the generic, biosimilar and value added medicines industries to help national health systems address the challenges of sustainability driven by an ageing population, and the increased prevalence of chronic diseases.

The current situation across Europe with regards shortages of essential medicines needs to be tackled. Our industry is ready to partner with governments to rapidly introduce policy reforms to ensure sustainable access to and availability of medicines. I call on the Commission and its newly elected President Ursula von der Leyen together with the designated Commissioner for Health Kyriakides to take action on sustainable access to medicines for patients, by setting up a high level pharmaceutical forum to tackle the challenges in the medicines sector.

I look forward to working with policy makers and stakeholders to strengthen the health and well-being of the citizens who rely on our medicines across Europe.”

 About Christoph Stoller

Christoph Stoller is a Senior Vice President of Teva and President Medicines for Europe.

In his current role as General Manager for Teva´s cluster Germany & Austria he is responsible for Teva´s Generics, OTC and Specialty Medicines businesses and he is Managing Director of all Teva´s legal entities in Germany. Until June 2017 he served as Chief Operating Officer Global Generic Medicines Europe. As part of that role he also led all activities integrating Actavis Generics into Teva in Europe as Chief Integration Officer Europe. In addition, he was responsible for the negotiations to get the approval of the European Commission and all associated divestment activities.

Christoph has been a member of the Board as well as of the Executive Committee of Medicines for Europe since 2014. Furthermore he has been pivotal in setting up the sector group on Value Added Medicines and has chaired that sector group until 2017.

Christoph has been working for Teva Europe in various roles with increasing responsibility since 2011 after having joined Teva as General Manager in Switzerland in July 2008. Before joining Teva he worked for Zur Rose Group as member of the Executive Board and General Manager Helvepharm, DSM, F. Hoffmann-La Roche and Swiss Re.

Christoph is a Swiss citizen and has a degree in business administration from the University of St. Gallen, Switzerland (lic.oec.HSG).

A DIGITAL FUTURE FOR VALUE ADDED MEDICINES – IQVIA publication shares the future of the sector

The value added medicines sector group of Medicines for Europe welcomes the publication from IQVIA’s Thought Leadership “A Digital Future for Value Added Medicines”.

The publication provides valuable insights on the drivers behind the sector, its challenges and what the future holds for value added medicines. The importance of regulatory and payer environments to evolve pragmatically and stimulate the development of this innovation as well as seizing the future digital endeavours are especially insightful.

Adrian van den Hoven, Director General of Medicines for Europe, commented: “IQVIA’s publication shows the future opportunity that value added medicines will bring to patients, healthcare communities and society. The report highlights important global trends and therapy areas that will shape the future of the sector. We encourage governments and the healthcare community to work together to optimise regulatory and reimbursement decision-making processes to take advantage of the opportunity of value added medicines!”

The full report can be accessed here.

Ready to drive access to medicines

Medicines for Europe is ready to engage with the EU to drive the access to medicines agenda in line with the European Council declaration of 20th June on good healthcare access. Our industry supplies close to 70% of prescription medicines and plays a fundamental role in lifting barriers for patient access to therapy. Generic medicines have doubled access to therapy in major chronic diseases over the last 10 years and biosimilar medicines offer a similar hope for patients requiring biological medicines. Value added medicines can empower patients and healthcare practitioners to improve treatment options – especially for chronic care.

To achieve equity of access to medicines, the EU needs focused pharmaceutical policies that stimulate competition in the off-patent medicine market:

  • Removing barriers to generic, biosimilar and value added medicines competition at the expiry of patents.
  • Committing to strong generic and biosimilar medicine uptake policies for maximum cost-effectiveness.
  • Investing the dividends of competition into expanded access to medicines for patients – using generic, biosimilar and value added medicines as first line treatment as well as new on-patent medicines for patients in need as second line.
  • Incentivising more investment in pharmaceutical manufacturing to guarantee secure supplies for European patients – especially for older essential generic medicines like antibiotics or injectable cancer medicines.
  • Optimising the regulatory system for off-patent medicines based on sound science, the expanded use of IT tools to reduce administrative redundancies and stopping the unethical duplication of clinical studies.
  • Enabling manufacturers to invest in continuous innovation of well-established molecules – including in digital technologies – to empower patients and healthcare practitioners to improve on existing treatments.

Equitable access to medicines should be the mainstay of an efficient, sustainable and cost-effective pharmaceutical policy of the European Union.

Find out more about Medicines for Europe’s policy priorities for the incoming European Institutional mandate, Together for Health here https://www.medicinesforeurope.com/together4health/

European Specialised Nurses Organisation (ESNO) launches translations into multiple European languages of switch management guide between similar biological medicines, for nurses

Committing to Global Health: Balancing Access and Sustainability key to success

  • Generic, biosimilar and value added medicine manufacturers deliver increased access to medicines worldwide.
  • This access could be threatened by shortsighted cost-containment policies that make manufacturing and supply unsustainable.
  • Focused pharmaceutical policies based on healthy competition, regulatory convergence, biosimilar medicines uptake and continuous innovation will deliver efficiency for healthcare, improved access to medicines and opportunities for manufacturers to invest for the future.

Global medicine manufacturers gathered in Warsaw this week to discuss the contribution of the generic, biosimilar and value added medicines to patient access and durable healthcare systems around the world.

Delivering access is at the core of the off patent sector. Generic medicines provide for 67% of dispensed medicines in Europe alone and have doubled access to medicines for patients with diabetes or cardiac conditions.

In an era of growing incidence rates of chronic diseases, global competition, and digitalisation, the sustainability of the industry cannot be left behind if the sector is to continue providing benefits for public health and the sustainability of healthcare systems.  Our call is for access-focused pharmaceutical policies, efficient international regulatory cooperation, fostering the use of biosimilar medicines, and facilitating continuous innovation for value added medicines. These are some of the pathways to deliver better healthcare globally.

Medicines for Europe President Marc-Alexander Mahl commented “We are committed to delivering better patient access to medicines. Industry and stakeholders need clear access-focused policies to ensure that the generic, biosimilar and value added medicines can continue delivering on public health. I look forward to working with the newly elected European Parliament and the incoming European Commission to achieve this.

Jim Keon, Chair of the International Generic and Biosimilar medicines Association (IGBA) commented “Developing international frameworks supporting true global development for generic and biosimilar medicines, a more competitive business environment for the off-patent sector around the globe as well as promoting the implementation of balanced, well-functioning and transparent intellectual property systems in all jurisdictions are essential to support equity of access to healthcare and the UN Member States vision of Universal Health Coverage (UHC) by 2030.”

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Huge European Parliament majority votes to adopt the SPC manufacturing waiver

  • The European Parliament adopted the SPC manufacturing waiver with a huge majority.
  • The waiver will improve access to medicine and create manufacturing job opportunities for Europe as of July 2022.
  • Medicines for Europe will work with its members to facilitate the practical use of the waiver and will monitor and act against any potential misuse of the notification system for frivolous litigation.

The European Parliament today voted overwhelmingly with 572 Members of Parliament in favour to adopt the Supplementary Protection Certificate (SPC) manufacturing waiver.  The SPC manufacturing waiver is now expected to be formally adopted by the European Council in the coming weeks.

Medicines for Europe commends the EU institutions for successfully concluding this important step in the adoption of the waiver. We congratulate the European Commission for proposing the waiver and the rapporteurs and shadow rapporteurs of the Legal, Trade and Health committees of the European Parliament as well as the European Council for substantially improving the manufacturing waiver to deliver access to medicines for European patients.

The SPC manufacturing waiver will enable the European pharmaceutical industry to compete on a level playing field globally for manufacturing opportunities in generic and biosimilar medicines which is growing year on year.

The waiver will come into force in July 2019 and companies will be able to start manufacturing under the waiver from July 2022. The Commission has evaluated the tremendous investments in new, high-skill jobs that this manufacturing for export and for day 1 launch can deliver for Europe[1]. The waiver’s notification measures should therefore not be misused to block generic and biosimilar medicines competition.

Adrian van den Hoven, Director General of Medicines for Europe commented “Today’s vote on the SPC manufacturing waiver reflects the EU’s commitment to access to medicines, manufacturing jobs in Europe and putting EU industry on a level playing field globally. Europe has everything to gain from fully implementing the waiver to enable more competition on the pharmaceutical market and to improve its own security of medicines supply.

[1] https://ec.europa.eu/docsroom/documents/29463

‘Together for Health’: Medicines for Europe launches election manifesto to deliver on equitable patient access

  • ‘Together for Health’ outlines a vision for a strong pharmaceutical policy for Europe.
  • The four pillars of the campaign outline the need to deliver on equitable access to medicines for all patients, robust and responsive regulatory frameworks, leadership in manufacturing and empowering the healthcare community.
  • Medicines for Europe calls for partnership with the European Union to deliver on the promise of generic, biosimilar and value added medicines for Europe.

Medicines for Europe has launched its vision for pharmaceutical policy ahead of the European elections. ‘Together for Health’ outlines the generic, biosimilar and value added medicines industry’s commitment to sustainable access to healthcare for all patients across Europe. The campaign is designed around four key pillars:

  1. Equitable access to medicines for all patients in Europe
  2. A responsible industry in a responsive regulatory framework
  3. Leadership in medicines manufacturing
  4. Empowering the healthcare community by improving existing therapeutic option

Commenting on the launch of ‘Together for Health’, Medicines for Europe Director General Adrian van den Hoven said “the EU elections are an opportunity to improve to healthcare across Europe. The EU can do more to ensure equitable access to medicines for patients for all Europeans. Our industry is ready to engage with the EU, national governments and stakeholders to make this happen.”

To view our policy priorities, please visit  www.medicinesforeurope.com/together4health

 

Accelerating the biosimilar medicines access journey through benefit-sharing

  • Biosimilar medicines have substantially improved equity of access to biological medicines, improving treatment for patients across Europe
  • Looking forward, Europe needs a sustainable market to encourage investment in future biosimilar medicine opportunities for patient access.
  • Benefit-sharing partnerships involving patients, physicians and payers, are essential to deliver on the promise of access to biosimilar medicines for all patients in need

Biosimilar medicines have significantly increased equity of access to important biological treatments across Europe and can massively improve disease management for patients with chronic conditions and cancer. They offer more prescribing options for physicians, their patients, and alleviate financial pressure on healthcare systems in an era of rapidly growing healthcare expenditure.

Biosimilar medicines can only deliver benefits for patients and sustainability for healthcare budgets in a framework that stimulates dynamic competition among multiple manufacturers. This requires governments to plan for future biosimilar medicines competition by actively removing barriers and implementing comprehensive uptake strategies based on benefit-sharing with stakeholders. Sustainable, dynamic and competitive markets are a prerequisite for a thriving biosimilar medicines pipeline and the much-needed competition of the future.

Erin Federman, Chair of Market Access Committee of the Biosimilar medicines, commented “Over the past 10 years, we have witnessed the game-changing contribution of biosimilar medicines in terms of access to treatment in auto-immune conditions and cancer care, including driving value to national healthcare systems. Now, we need governments to adopt the right policies, to foster healthier competition and create a better uptake environment to ensure the next generation of biosimilar medicines can deliver for patients.

Major challenges in the Intellectual Property (IP) environment for pharmaceuticals debated at Medicines for Europe Legal Conference

  • The changing IP landscape for pharmaceuticals was heavily debated at the Medicines for Europe Legal Affairs Conference in Amsterdam today
  • The highly anticipated SPC manufacturing waiver is a major advancement for pharmaceutical manufacturing in Europe
  • Major barriers to access to medicines still need to be addressed such as patent linkage and ensuring the quality of patent systems in Europe

The SPC manufacturing waiver, which will put an end to the legal requirement to delocalise pharmaceutical production outside of Europe, was lauded as a positive step for competition and security of supply of medicines at the 15th Legal Affairs conference in Amsterdam.

Stakeholders, government representatives, lawyers and industry experts took stock of the ten year anniversary of the EU Pharmaceutical Sector Enquiry at the event. Experts expressed major concerns that patent linkage continues to be a barrier to competition and timely access to generic and biosimilar medicines in several Member States despite the clear decision 10 years ago to ban this anti-competitive practice as a conclusion of the Enquiry.

Experts also questioned why the European patent system has failed to address documented problems with patent quality in relation to the pharmaceutical sector. Failing to address this issue undermines the credibility of the system and risks delaying access to medicines.

Experts also exchanged best practice in litigation strategies to promote greater access to biosimilar medicines at expiry.

Sergio Napolitano, Legal and External Affairs Director at Medicines for Europe commented “.  EU Governments rely more and more on generic and biosimilar medicines to ensure equity of access to medicines for patients.  It is essential to ensure that the patent system and regulatory incentives for pharmaceuticals do not unduly delay access to medicines for patients. The SPC manufacturing waiver shows that the EU can easily tailor regulatory incentives to favour access and growth in Europe while maintaining strong incentives for the originator industry.”

 

Joint Press Statement of the Inter Associations Initiative (IAI) Pharmaceuticals in the Environment Task Force (AESGP, EFPIA, Medicines for Europe) – European Union Strategic Approach to Pharmaceuticals in the Environment