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Pfizer Inc.

PFE

Pfizer is a global biopharmaceutical company developing medicines and vaccines to extend and improve lives.

Lobbying Activity

Meeting with Andi Cristea (Member of the European Parliament) and American Chamber of Commerce to the European Union and

25 Nov 2025 · Recent developments in EU-US trade policy

Meeting with Hildegard Bentele (Member of the European Parliament) and American Chamber of Commerce to the European Union and

8 Oct 2025 · Biotech

Response to EU cardiovascular health plan

16 Sept 2025

Pfizer welcomes the European Commissions initiative to develop a comprehensive EU Cardiovascular Health Plan (CVH Plan), recognizing cardiovascular diseases (CVDs) as the leading cause of mortality and a major contributor to healthcare burden across Europe. With over 1.7 million deaths annually and economic costs exceeding 280 billion, the urgency for coordinated EU-level action is clear. Pfizer supports the Plans ambition to reduce premature and preventable deaths by one-third by 2030. This goal is achievable through a robust framework that integrates innovation, prevention, early detection, and equitable access to care. As a science-driven biopharmaceutical company, Pfizer is well-positioned to contribute through advanced technologies, vaccines, and public-private collaboration. Integrating prevention, early detection, and equitable access aligns with the recent efforts of the Commission and the other EU institutions to enhance the framework on predictive and personalized care. This must include policies and resources that ensure timely testing, diagnosis, and treatment of respiratory diseases for high-risk patients, while expanding access channels, such as enabling pharmacists to assess and support them. Individuals suffering from CVDs often have weakened immune systems, making them more susceptible to vaccine-preventable respiratory diseases (VPRDs) such as influenza, COVID-19, RSV, and pneumococcal infections. The co-circulation of these diseases exacerbates morbidity and mortality among CVDs patients. CVDs can indirectly impact respiratory health by affecting the heart and blood vessels, leading to a higher risk of hospitalization due to respiratory infections like pneumonia, which occurs at rates 2-3 times higher than in the general population. Vaccination against respiratory viruses helps reduce complications in people with CVDs and can even provide direct heart protection. Evidence shows clear benefits: influenza vaccination lowers CVD-related deaths by a third and heart attack risk by a quarter, COVID-19 vaccines reduce death and hospitalization from acute and long COVID, RSV vaccination may prevent cardiac events linked to respiratory illness, and pneumococcal vaccination cuts the risk of heart attack by over a quarter and overall mortality by nearly a quarter. Despite the protective benefits of vaccinations, uptake among adults with non-communicable diseases (NCDs), including CVDs, remains low. For instance, influenza vaccine uptake among patients with chronic heart disease in the UK dropped from 49.8% in the 20222023 winter season to 41.7% in the 20232024 season. Moreover, a 2024 study across EU countries revealed that individuals with high blood pressure were 3% less likely to report receiving both COVID-19 and influenza vaccines compared to those without the condition. Even countries with high vaccination rates may still face surges in morbidity and mortality when new variants or seasonal pathogens strike, underscoring the importance of complementary prevention tools, including antivirals and innovative therapies. We recommend actionable steps to embed these priorities, including strengthening prevention and setting measurable targets aligned with SDG 3.4 and EU equity goals. Expand vaccination by scaling programmes against infection-related cardiovascular risks, prioritizing at-risk groups such as CVDs patients, embedding vaccination in the EU CVH Plan and national strategies. Improve treatment by ensuring consistent access to innovative therapies, including oral antivirals where appropriate, reducing hospitalizations and supporting at-home care options that help lessen the burden on healthcare systems. Improve treatment by supporting adherence through digital and AI tools and training healthcare providers to communicate vaccination benefits for CVDs patients. Ensure policy coherence by aligning measures with the European Beating Cancer Plan for an integrated NCDs framework.
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Pfizer Warns EU Critical Medicines Act Risks Undermining Innovation

4 Jul 2025
Topic — EU regulation to strengthen pharmaceutical supply chains and prevent medicine shortages.
Message — Pfizer requests risk-based measures and comprehensive impact assessment before implementation. They advocate for strategic partnerships and diversified trade rather than local production requirements. The company opposes expanding joint procurement beyond health emergencies and seeks narrower focus on Union List medicines.1234
Why — This would preserve their global supply chain flexibility and prevent costly localization requirements.567
Impact — European manufacturers lose advantage as rules favor Pfizer's global production model over local supply.89
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Meeting with András Tivadar Kulja (Member of the European Parliament, Shadow rapporteur for opinion)

1 Jul 2025 · Critical medicines act

Pfizer Calls for Faster Clinical Trials and Enhanced Biotech Funding

11 Jun 2025
Topic — EU regulation to accelerate biotechnology innovation from laboratory to market.
Message — Pfizer requests faster clinical trial approvals through early scientific dialogues and reinforced ethics review provisions. They want dedicated funding programs for biotech SMEs and support for specialized biohubs. They also seek expanded use of real-world data in regulatory decisions.123
Why — This would speed up drug approvals and reduce research costs through public funding.45
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Meeting with Margarita De La Pisa Carrión (Member of the European Parliament) and Asociación Española Contra el Cáncer

11 Jun 2025 · Beating Cancer Plan

Meeting with Aurelijus Veryga (Member of the European Parliament)

23 Apr 2025 · Joint procurement in the Critical Medicines Act – impact on access and EU competitiveness

Meeting with Tomislav Sokol (Member of the European Parliament)

23 Apr 2025 · Health policy

Pfizer urges EU life sciences investment to reverse innovation decline

16 Apr 2025
Topic — EU strategy to boost life sciences competitiveness, innovation, and reduce dependencies.
Message — Pfizer requests stronger intellectual property protections, streamlined regulatory frameworks, and development of biohubs connecting universities and companies. They emphasize positioning healthcare as strategic investment rather than cost, and promoting sustainable procurement without discriminatory 'made in Europe' provisions.1234
Why — This would attract pharmaceutical R&D investment back to Europe and reduce regulatory compliance burdens.56
Impact — European manufacturers lose if 'made in Europe' provisions are excluded from public procurement.7
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Meeting with Pascal Canfin (Member of the European Parliament, Shadow rapporteur) and Inter Ikea Systems BV

16 Apr 2025 · Omnibus I

Meeting with Kristoffer Storm (Member of the European Parliament) and Affordable Medicines Europe

9 Apr 2025 · Pharmaceutical Industry

Meeting with Niels Flemming Hansen (Member of the European Parliament)

9 Apr 2025 · Lægemiddelspakke

Meeting with Carlo Ciccioli (Member of the European Parliament, Shadow rapporteur)

7 Apr 2025 · ITRE INI on the future of Biotechnologies and Biomanufacturing

Meeting with Stéphane Séjourné (Executive Vice-President) and

21 Mar 2025 · - Marché intérieur - Compétitivité - Sécurité économique - Simplification - Relation USA / Europe

Meeting with Billy Kelleher (Member of the European Parliament)

18 Mar 2025 · Pharmaceutical strategy and trade

Meeting with Eva Maydell (Member of the European Parliament)

18 Mar 2025 · EU-US Relations

Meeting with Tomislav Sokol (Member of the European Parliament)

18 Mar 2025 · Health policy

Pfizer advocates for global partnerships to secure medicine supplies

27 Feb 2025
Topic — EU consultation on strengthening supply chain resilience for critical medicines across Europe.
Message — Pfizer requests that the EU prioritize international trade agreements and global manufacturing diversity over local production requirements. They also advocate for harmonized stockpiling rules and procurement processes that reward supply continuity.123
Why — Pfizer avoids the high costs of localizing production by maintaining its existing global manufacturing network.45
Impact — Supporters of European strategic autonomy lose if policies favor global networks over local manufacturing.6
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Meeting with Stine Bosse (Member of the European Parliament) and Greater Copenhagen EU Office

13 Dec 2024 · European health policy

Meeting with Valérie Hayer (Member of the European Parliament) and L'Oréal

10 Dec 2024 · Évènement Politico - Divers

Meeting with András Tivadar Kulja (Member of the European Parliament)

14 Nov 2024 · Biotech Act, medicines shortages

Meeting with Niels Flemming Hansen (Member of the European Parliament)

26 Sept 2024 · Priorities for the mandate

Meeting with Ruggero Razza (Member of the European Parliament) and Vaccines Europe

17 Jul 2024 · Incontro conoscitivo e scambio di vedute sul mandato del Parlamento europeo

Meeting with Stine Bosse (Member of the European Parliament)

17 Jul 2024 · EU health policy

Meeting with Jörgen Warborn (Member of the European Parliament) and Almega

17 Jul 2024 · Trade

Meeting with Wouter Beke (Member of the European Parliament)

16 Jul 2024 · Health policy / internal market, freedom of mobility, digital and wider consumer policies

Meeting with Jörgen Warborn (Member of the European Parliament)

25 Jan 2024 · TRIPS

Pfizer warns EU pharmaceutical reforms risk undermining innovation leadership

31 Oct 2023
Topic — EU revision of pharmaceutical legislation to improve medicine access and affordability.
Message — Pfizer supports streamlined regulatory processes and antimicrobial incentives but opposes making regulatory data protection contingent on launching across all 27 Member States. They argue this ignores fragmented market access dynamics and places entire burden on companies rather than addressing root causes in national reimbursement processes. On supply security, they want definitions to reference medical demand and oppose mandatory shortage prevention plans for all medicines as disproportionate and resource-intensive.12
Why — This would preserve their regulatory data protection without requiring launch commitments across fragmented markets.3
Impact — Patients in smaller EU markets lose leverage for faster medicine launches.
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Meeting with Fabio Massimo Castaldo (Member of the European Parliament)

24 Oct 2023 · Sickle Cell Disease landscape and challenges in the Europe

Meeting with István Ujhelyi (Member of the European Parliament)

24 Oct 2023 · Sickle Cell Disease

Meeting with Geoffroy Didier (Member of the European Parliament, Shadow rapporteur)

18 Oct 2023 · Compulsory licensing

Meeting with Catherine Amalric (Member of the European Parliament, Shadow rapporteur)

16 Oct 2023 · Reform of the EU pharmaceutical legislation

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur) and Confederation of Danish Industry and

13 Oct 2023 · Directive on Medicinal products for human use

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur)

6 Oct 2023 · Directive on Medicinal products for human use

Meeting with Tomislav Sokol (Member of the European Parliament, Shadow rapporteur)

3 Oct 2023 · Pharmaceutical legislation

Meeting with Tomislav Sokol (Member of the European Parliament, Shadow rapporteur)

19 Sept 2023 · Pharmaceutical legislation

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur)

7 Sept 2023 · Directive Medicinal products for human use

Response to Compulsory licensing of patents

28 Jul 2023

Pfizer welcomes the opportunity to respond to the proposal. Our purpose Breakthroughs that change patients lives fuels everything we do and reflects our passion for science and our commitment to patients. Alongside this, a strong system of intellectual property (IP) protection provides the economic incentive necessary to achieve sustainable scientific advancement and enable companies like Pfizer to apply their science and global scale to research, develop and distribute medicines around the world. We understand that the limited, narrow use of a compulsory license (CL) to address a national health emergency may be appropriate if all other options have been exhausted and the problem is truly urgent. EU countries already have CL regimes in place to address such emergencies, if required and necessary. We are concerned that the proposed Regulation would undermine the legal certainty provided by the IP system by introducing a broad-reaching, vague, ambiguous and unclear CL framework. As shown by the COVID-19 crisis, IP incentives enabled Pfizer to build an infrastructure that allowed us to quickly mobilise and devote the resources and know-how required to help combat the pandemic. Maintaining a system that provides legal certainty and facilitates collaboration between trusted partners is what will fuel the next generation of solutions and enable us to address future crises. In addition to our concern around the weakening of IP protections in the EU and the harmful precedent this proposal will set, we have substantive concerns with the proposal, including, but not limited to: - Vague definition of a crisis: The proposal fails to clearly define a key aspect of the proposal, i.e., what constitutes a crisis or how it is triggered for the purposes of initiating an EU-level CL. The Articles also fail to state that a CL should be used only as a last resort and only after attempts to negotiate voluntary licences have failed. - Unclear role and constitution of the Advisory Board: More clarity is needed regarding the specific responsibilities and constitution of the Board. Any such body should have a clear remit and composition that reflects the necessary expertise; industry/rights holders, for example, should be included. - Inclusion of patent applications in scope of CLs: Such inclusion calls into question its compliance with the WTO TRIPS Agreement. - Risks from undefined "additional measures complementing" the CL: The proposal lacks any indication of what these measures could include. A significant concern is that they may include obligations to share know-how and/or trade secretswhich should not be in the scope of the CL or this provision and should be expressly excluded. - Powers to impose severe, disproportionate financial penalties for breach of vague and opaque obligations of good faith and cooperation and best efforts to effect the CL. - Alongside each other, the above two points would risk bringing a form of forced tech transfer into the scope of the EU CL, setting a very dangerous precedent and enormously increasing the negative impact of this proposal and the threat it presents to IP protection and innovation in the EU. - Capping adequate remuneration doesnt take into account the circumstances of each case, nor the economic value of the authorization as required by Art. 31(i) of the TRIPS Agreement. - Rights of due process: Given the significance of the impact on IP owners if there is a grant of any such proposed EU CL, it is essential to clarify and strengthen the process for imposing an EU CL and the IP owners rights of judicial review in that eventuality. There is no evidence to support the notion that CLs will strengthen and facilitate the EUs efforts to improve its resilience to crises. As demonstrated time and againthrough facts and evidencethe IP system is an enabler, not a hindrance, to crisis management. We urge the European Parliament and the Council to reconsider this proposal.
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Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur) and American Chamber of Commerce to the European Union and

11 Jul 2023 · Directive on Medicinal products for human use

Meeting with Mairead McGuinness (Commissioner) and

2 Mar 2023 · Introductory meeting

Meeting with Sirpa Pietikäinen (Member of the European Parliament)

15 Feb 2023 · EU’s general pharmaceutical legislation and EU Regulation on Orphan Medicinal Products (OMPs)

Meeting with Kathleen Van Brempt (Member of the European Parliament, Committee chair)

26 Jan 2023 · Decision by the COVI Committee Coordinators on the request to withdraw long-term access badges of Pfizer (APA)

Meeting with Kathleen Van Brempt (Member of the European Parliament, Committee chair)

24 Jan 2023 · Decision by the COVI Committee Coordinators on the request to withdraw long-term access badges of Pfizer (APA)

Meeting with Kathleen Van Brempt (Member of the European Parliament, Committee chair)

30 Nov 2022 · Participation of dr. Albert Bourla, CEO of Pfizer, in a second hearing

Meeting with Kathleen Van Brempt (Member of the European Parliament, Committee chair)

25 Nov 2022 · COVID-19: deelname Dr Bourla aan hoorzitting van de COVI-commissie - APA

Meeting with Dolors Montserrat (Member of the European Parliament, Rapporteur)

8 Nov 2022 · Lessons learned on impact of COVID-19 pandemic

Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur)

25 Oct 2022 · medicines

Meeting with Stella Kyriakides (Commissioner) and

12 Oct 2022 · Exchange on-going cooperation; Europe's Beating Cancer plan - exchange on innovation in the future of cancer treatment and care

Meeting with Andreas Glück (Member of the European Parliament, Committee chair)

4 Oct 2022 · COVID19 lessons learned

Meeting with Margaritis Schinas (Vice-President)

9 Sept 2022 · Pharma Strategy

Meeting with Karin Karlsbro (Member of the European Parliament) and SANOFI and

17 May 2022 · Pharmaceuticals

Meeting with Cyrus Engerer (Member of the European Parliament) and Novartis International AG

3 Dec 2021 · Joint Procurement of Medicines

Meeting with Cyrus Engerer (Member of the European Parliament)

3 Dec 2021 · Pharmaceutical Strategy

Meeting with Ursula von der Leyen (President)

26 Nov 2021 · Meeting with CEO of Pfizer

Meeting with Caroline Boeshertz (Cabinet of Executive Vice-President Valdis Dombrovskis), Elina Melngaile (Cabinet of Executive Vice-President Valdis Dombrovskis), Kevin Keary (Cabinet of Executive Vice-President Valdis Dombrovskis) and

26 Oct 2021 · Pharmaceutical sector – trade related issues

Meeting with Giorgos Rossides (Cabinet of Commissioner Stella Kyriakides), Roberto Reig Rodrigo (Cabinet of Commissioner Stella Kyriakides)

18 Oct 2021 · Call with Pfizer’s Regional President for Vaccines, Mr. Sinan Atlig, to discuss the implementation of COVID-19 vaccines Advance Purchase Agreement

Meeting with Nicolae Ștefănuță (Member of the European Parliament)

15 Oct 2021 · Meeting regarding Pfizer vaccine

Meeting with Margaritis Schinas (Vice-President) and

16 Jun 2021 · Supply chains for medicines

Meeting with Maurits-Jan Prinz (Cabinet of Commissioner Thierry Breton)

7 May 2021 · Site visit and assessment of production capacity and supply chain

Response to Evaluation and revision of the general pharmaceutical legislation

27 Apr 2021

Pfizer acknowledges that access, affordability and availability of medicines are key priorities of the EU Pharma Strategy. We remain committed to partner with EU policy-makers to address these challenges. However, the root causes of obstacles to the availability of innovative medicines are multi-factorial and fall mostly beyond EU competences. They cannot be addressed by tampering with the regulatory and IP incentives framework or by imposing new conditions for such incentives. This could undermine Europe’s ambition to be a world leader in medical innovation. To address access inequalities across Europe, the Commission should establish a High-Level Forum on Better Access to Health Innovation to discuss e.g. novel payment models for paradigm-shifting treatments such as gene therapies and common principles to align medicines’ prices to the level of economic development of the country concerned. To address market failures and foster R&D in novel antimicrobials against AMR, we urge the Commission to implement a robust pull incentive at EU level in the form of transferable exclusivity extensions. To improve environmental sustainability of medicines without delaying access, Pfizer encourages the Commission to implement industry’s proposed extended Environmental Risk Assessment. This mechanism would ensure ongoing environmental review post-marketing authorisation approval for new APIs authorised since 01/12/2006. To support resilient supply of medicines, Pfizer encourages policy measures including work to facilitate global supply chains, avoiding distortive measures such as stockpiling, and increasing access to real-time data. We operate one of the most sophisticated supply chain systems in the industry (see attached our manufacturing & supply operations in EU). Our ability to meet patients' needs depends on the ability to maintain a supply chain that is both flexible and resilient. We support the EC objective to adapt the regulatory framework to new scientific advances. We would welcome the exemption of ATMPs containing or consisting of GMOs from the EU’s GMO legislation. This would not only make Europe more attractive for ATMP clinical development but would accelerate patient access. To address inefficient and unnecessary administrative burdens associated with current EU regulatory procedures, much can be achieved without requiring legislative reopening. Pfizer supports and contributes to EFPIA’s Regulatory Road to Innovation. We also believe ensuring the EMA has all the resources to fully implement its Regulatory Science Strategy to 2025 will substantially deliver an attractive regulatory system that supports innovation, simplifies and streamlines procedures, reduces timelines and regulatory burden. However, if the legislation is to be reviewed, Pfizer would encourage the Commission to focus on the following areas: - Enhancing the PRIME scheme to make it a globally desirable designation that supports development of innovative medicinal products. We support incorporation of PRIME into the legal framework as a mechanism to strengthen its use. - Ensuring that available expedited regulatory pathways are being used optimally; data indicates their use, connectivity and impact have been limited to date and could be improved. - Investigate how regulatory review times can be better aligned with review times from other major regions. While average review times in the US, Japan and China have reduced over recent years, average review times in the EU have remained constant, putting the EU regulatory framework at a global disadvantage. One potential area for review is the process for decision making following adoption of a CHMP scientific opinion. Any efforts to accelerate and simplify the regulatory processes should not however create additional burden for downstream decision-making, causing further delays to patients gaining access to innovative, breakthrough products. We welcome the intent to consider potential synergies.
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Meeting with Thierry Breton (Commissioner)

10 Apr 2021 · Vaccine production and deliveries

Meeting with Maurits-Jan Prinz (Cabinet of Commissioner Thierry Breton)

7 Apr 2021 · Vaccine delivery schedule for Q2 2021

Meeting with Thierry Breton (Commissioner)

21 Feb 2021 · COVID-19 vaccines production

Meeting with Ursula von der Leyen (President) and SANOFI and

31 Jan 2021 · Meeting with CEOs of the pharmaceutical companies with which the Commission has signed Advance Purchase Agreements

Response to Revision of the EU legislation on medicines for children and rare diseases

4 Jan 2021

As an innovative biopharmaceutical company, Pfizer is a global leader in R&D of new treatments for paediatric and rare diseases. In the EU, the framework created by the Orphan and Paediatric Medicines Regulations has allowed investment in areas of unmet need, to the benefit of millions of patients. We are aligned with the European Commission (EC)’s view, mirrored in the Pharmaceutical Strategy for Europe, that we need a strong and competitive industry that delivers for patients; we are also aligned with the four work streams identified. However, we fail to see how the proposed policy options in the Inception Impact Assessment (IIA) would help achieve the EC’s stated objectives. There is a striking incongruity between the recognition of the added value brought by the Regulations, reflected in the EC Staff Working Document (SWD), and the policy options set out in the IIA. These would remove many of the incentives and rewards for the important and difficult task of developing medicines for very small patient populations and conditions, for which in many cases the basic science may be undeveloped or lacking, such as rare paediatric diseases. The proposed modifications will not lead to more new treatments nor to greater competition from generics/biosimilars, nor to wider access for patients. In our view, the outcome of such measures would be rather the opposite and would further negatively affect Europe’s global competitiveness in life sciences. As an example, generic/biosimilar entry in the field of rare diseases is already limited, as those companies likely find the financial returns insufficient. The reduction of incentives for innovative pharmaceutical companies to develop new products for rare diseases would not make this area more attractive to generic/biosimilar companies, but it would certainly make it even less attractive for innovators. Applying stricter criteria to grant orphan designation may also negatively impact the 98.6% of rare disease patients affected by 10.9% of the more prevalent rare diseases (Wakap et al., 2009). Furthermore, where novel medicines have been authorised, they rarely suit all patients on a permanent basis, such that investment in continued innovation, with significant benefit over available treatments, is still needed to address remaining unmet needs of patients. Pfizer calls for a more positive approach, building on and complementing the successes of the existing frameworks and the promising medicinal development activities in progress. In relation to the Paediatric Medicines Regulation, notably, at least some of the issues identified could be addressed by implementing the existing EC/EMA Paediatric Action Plan, streamlining requirements and enhancing dialogue and coordination. This should be combined with focused and realistic proposals to enhance R&D in areas of unmet medical need, aligned and in collaboration with other jurisdictions, such as the US, considering the global nature of medicines development. The importance of a stable regulatory framework, recognized by the EC in the Pharmaceutical Strategy, should be translated into practice and reasonable and achievable enhancements should be prioritized. We recognise the existing challenges in accessibility and affordability of medicinal products to European patients. However, as noted by the EC itself in the SWD, these are due to a multitude of factors, mostly beyond the scope of EU legislation. The proposals in the IIA would not solve the root causes of the problem and would have limited practical results. We therefore believe that such challenges should be outlined and discussed with the involvement of all stakeholders, via the establishment of a High-Level Forum as already called for by the EU Health Coalition and by the European Parliament in its latest report on the EU’s Industrial Strategy.
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Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

6 Jul 2020

Pfizer has invested in Europe since 1952. We employ over 18.000 people here and operate 12 R&D and manufacturing sites across 8 Member States, including for APIs and vaccines. We conducted over 900 clinical trials in the EU and are involved in 323 R&D partnerships with EU universities and biotechs (2018). Over 60% of our medicines globally are handled here, with exports reaching patients in over 170 countries. Moreover, 85% of APIs for our patented medicines comes from Europe. With this in mind, we aim to contribute to a Pharmaceutical Strategy which advances pro-patient and pro-innovation policies and provides an environment for the pharmaceuticals sector to flourish. We are aligned with EFPIA’s response to this consultation and would like to add the following reflections: Innovative partnerships for better access: Root causes of obstacles to the availability of innovative medicines are multi-factorial. They cannot be addressed by tampering with the regulatory and IP incentives framework, integral to Europe’s ambition to be a world leader in medical innovation. We support the EU Health Coalition’s call for a High-Level Forum on Better Access to Health Innovation to discuss, inter alia, common principles to align medicines’ prices to the level of economic development of the country concerned. In addition, to increase access to paradigm-shifting treatments such as gene therapies while addressing affordability concerns, the EU should enable and encourage the implementation of novel payment models such as spread payments, currently limited by EU accounting rules. A world-class R&D incentives ecosystem: A key objective of the Pharma Strategy is to “support the European pharmaceutical industry to remain an innovator and world leader”, linking to the EU Industrial Strategy. To achieve this goal, the EU must ensure a world-class incentives ecosystem to attract investment into the development of future treatments for the benefit of patients, including those with rare and paediatric diseases. We believe this can be best achieved via targeted, non-legislative initiatives. To increase R&D in much-needed new antimicrobials to fight AMR, instead, we call for a specific EU Regulation establishing a market-based ‘pull’ incentive, notably transferable exclusivity, with stewardship conditions. A science-based, competitive and effective regulatory framework: The Roadmap lacks concrete tools to support and encourage clinical development in Europe. This would include more competitive approval times and reduced administrative burden. By implementing the EMA’s 2025 strategy and the Network Strategy, regulatory improvements can be achieved efficiently without the need for legislative change. We also call for a more flexible and simplified post-approval process to monitor the safety and benefit-risk of medicines. To advance the Green Agenda, we support an extended environmental risk assessment to address latent discovered issues, as outlined in the industry’s Eco-Pharmaco-Stewardship approach. This would enable manufacturers to address environmental risks without undermining access to medicines. Flexible and resilient supply chains: During the COVID-19 pandemic, Pfizer was able to meet the increased demand (150-300% higher than average) thanks to our stable and sophisticated global network and healthy pre-COVID inventory safety stocks. We remain committed to working with the EU and Member States on initiatives that support innovative, sustainable manufacturing and supply chain resilience to secure supply for patients. A fragmented, localised approach will not achieve this shared goal. Other measures include enabling rapid and efficient scale-up for supply of quality medicines and vaccines; reducing tariffs and other trade barriers; fighting counterfeit medicines; advancing harmonized regulations; strengthening regulatory oversight in third countries; and sharing data on availability and demand, especially in public health emergencies.
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Response to Europe’s Beating Cancer Plan

2 Mar 2020

Pfizer welcomes the European Commission’s efforts laid out in the Roadmap to address the heavy burden that cancer places on people and their societies. Pfizer is committed to continuing the development of innovative methods for the prevention, diagnosis, and treatment of cancer, including cancers that become resistant to certain types of treatment. Early diagnosis and screening: In oncology, the ability to diagnose the disease as early as possible can lead to improved outcomes. As biomarker-driven therapies are developed through precision medicine approaches, the ability to understand the genetic underpinnings of the cancer can further improve patient outcomes. Therefore, access to diagnostic tools and, in cases of hereditary diseases, genetic counselors, are critical in the care of patients with cancer. Pfizer encourages the development of programs that support early diagnosis and screening for cancers. Pfizer supports research into biomarkers and the development, broader reimbursement, and adoption of companion diagnostics to improve the decision-making process of tailoring treatments to the patient. Supporting basic research: Simultaneous efforts should be made both on prevention and treatment given that not every cancer is preventable. Pfizer supports policies and partnerships that promote the further advancement of basic research to better understand the underpinning science of different forms and subtypes of cancers, and translational research to ensure that novel therapeutic targets and innovative delivery technologies move forward into drug development. Pfizer advocates for strengthening EU’s medical research, translation and the creation of value from knowledge and increasing both publicly and privately funded research. Patient inclusion: Pfizer supports the integration of the patient voice at each step of the pipeline. Pfizer engages in a variety of partnerships and initiatives, whose long-term goals include end-to-end integration of patient priorities and preferences throughout research and development, to product registration, and for as long as a product is available. Pfizer also believes patients offer a vital perspective in how health systems assess new health technologies for wide adoption and reimbursement. Educational programs: Pfizer supports the development of education programs for all healthcare stakeholders around cancer prevention and treatment approaches. Continued education is also needed to help healthcare providers and patients understand and adopt the latest medical advances such as precision medicines techniques, immunotherapy, combination treatments, and cell-based gene therapies. Pfizer supports increasing workforce participation and flexibility in service delivery (i.e. increased role for oncology nurses). Access: Pfizer encourages bridging the current disconnect between regulatory and pricing and reimbursement procedures to minimize the growing disparities in care delivery and outcomes within and across countries. The price of cancer medicines should reflect their value to patients, health systems, and society, with the goal of providing broad and affordable patient access. Pfizer works to achieve the broadest access possible while maintaining sustainable innovation in research and development, to the benefit of patients. Pfizer believes that all individuals deserve access to quality healthcare, including access to cross-border clinical trials, and the opportunity to lead healthy lives, regardless of the stage of cancer and age of the patient. Pfizer is committed to the development and implementation of policies, working with EU and global stakeholders and within national cancer plans, which will create an ecosystem that leverages scientific progress and changes the trajectory of the disease, while at the same time support patients and survivors.
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Meeting with Nele Eichhorn (Cabinet of Vice-President Cecilia Malmström)

27 Nov 2018 · EU-US relations, trade aspects of Brexit

Meeting with Vytenis Andriukaitis (Commissioner) and

29 Nov 2017 · Pharmaceutical incentives, antimicrobial resistance

Meeting with Jyrki Katainen (Vice-President) and Bayer AG and Novartis International AG

21 Nov 2017 · Internal Market's industrial property legal framework relating to supplementary protection certificates (SPC) and patent research exemptions; innovation in the pharmaceutical industry

Meeting with Pierre Moscovici (Commissioner) and

1 Sept 2017 · Exchange of views on the Italian and euro zone economies and priorities for reform

Meeting with Bernardus Smulders (Cabinet of First Vice-President Frans Timmermans) and DIGITALEUROPE and

14 Jan 2016 · AECA Round-Table on “Dealing with Regulatory Burden

Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis)

2 Mar 2015 · Access to innovative medicine

Meeting with Rolf Carsten Bermig (Cabinet of Commissioner Elżbieta Bieńkowska)

27 Jan 2015 · Introductory meeting