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BGP Products Operations GmbH – a Viatris Company

Viatris

Viatris is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, leveraging the strengths of both companies and approximately 38,000 colleagues worldwide.

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 Pietro Fiocchi (Member of the European Parliament)

15 Oct 2025 · Critical medicine act

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

8 Oct 2025 · Biotech

Meeting with Olivér Várhelyi (Commissioner) and

2 Oct 2025 · All pressing portfolio topics

Meeting with Aurelijus Veryga (Member of the European Parliament)

16 Jul 2025 · Improving Medicine Supply Chains in Europe

Response to Critical Medicines Act

3 Jul 2025

Viatris as one of the major suppliers of critical medicines to the European market welcomes the European Commissions proposal for a Regulation on the Critical Medicines Act as a vital step toward ensuring availability and security of supply of critical medicinal products. To further strengthen supply security, diversify supply chains, and improve patient access to critical medicines across Europe, the following recommendations should be introduced into the legislation. The proposal should reinforce the diversification in pharmaceutical supply chains as a key indicator of security of supply for multisourced off-patent medicines. No country can make every medicine it needs, and no medicine is made in every country. The proposed Act rightly underlines the need for diversifying supply chains through international partnerships to strengthen supply security, avoid risks linked with consolidated supply chains, and diversify risks. It should support the inclusion of dedicated health security chapters in free trade agreements to address export restrictions, cooperation in health emergencies, and regulatory cooperation and convergence as the highest priorities in pharmaceutical tradeas exemplified by the ongoing dialogue on EU-India FTA. The EU should promote openness and reciprocal solidarity in imports from international trade partners to strengthen domestic supply security, while also maintaining the export of critical medicines produced in Europe to support global health security. We welcome the improvement to existing procurement rules to enhance supply security by rewarding diversity in supply chains to ensure patient access to medicines, while aligning with EUs objectives on environmental sustainability and supply resilience. We support the shift from price-only tender criteria to the MEAT procurement model. In addition, pricing systems should be flexible enough to allow MAHs to adjust prices in response to rising operational costssuch as new regulatory requirements or inflationto safeguard the economic viability and continued availability of essential off-patent medicines. National stockpiling obligations are not the answer to avoid out-of-stock situations and can put access at risk by inadvertently undermining access to critical medicines in other locations. Encouraging diversification of suppliers, increasing demand predictability for MAHs, and preventing disproportionate penalties to MAH are more efficient in addressing the root causes of supply shortages. Current regulatory requirements for these medicines increase supply chain complexity and costssuch as varying national shortage reporting obligations and diverse packaging and labelling rules. We recommend harmonizing pack formats and introducing electronic patient leaflets to reduce manufacturing complexity and facilitate movement between countries in the event of disruptions or major shortages. Likewise, simplifying shortage reporting and increased collaboration on forecasting of medicines supply would reduce cost and complexity, facilitating quicker responses and more effective coordination between industry, regulators and healthcare providers. The proposal should also consider the cumulative impact of increasing obligations and costs for MAHs under pharmaceutical, chemical, and environmental legislationparticularly in relation to the economic viability and continued availability of critical medicines. It is essential to strike a careful balance between ensuring patient access and imposing new regulatory requirements on pharmaceutical companies. Robust impact assessments on access to medicines must be conducted before any new regulations are introduced. Ideally, DG HERA should play a proactive role in anticipating the impact of horizontal legislation on the long-term viability of critical medicines and aligning with Member States on the market incentives that would allow off-patent medicines to remain available.
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Meeting with Olivier Girard (Head of Unit Health Emergency Preparedness and Response Authority)

26 Jun 2025 · Exchange of views on advancing the access and availability of medical countermeasures

Meeting with Tomislav Sokol (Member of the European Parliament, Rapporteur) and A. Menarini Industrie Farmaceutiche Riunite s.r.l.

13 May 2025 · Health policy

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

24 Apr 2025 · Critical Medicines

Meeting with Tiemo Wölken (Member of the European Parliament, Shadow rapporteur) and European Haemophilia Consortium

10 Apr 2025 · Critical Medicines Act

Response to Evaluation of the Public Procurement Directives

7 Mar 2025

A revision of the EU Public Procurement Directive (PPD) presents a critical opportunity to ensure a sustainable, competitive, and resilient medicines supply.The European Commission (EC) should consider the following evidence-based reforms: 1. Public procurement must prioritize MEAT over price-only criteria.While the PPD (2014/24/EU) encourages a strategic approach through MEAT criteria, its adoption in medicines procurement remains limited.This undermines manufacturers ability to invest in supply chain resilience and environmental measures.It can drive industry consolidation, reducing market competition and exacerbating supply chain vulnerabilities, leading to medicine shortages.The revision of PPD should explicitly introduce MEAT criteria and support their uptake across Member States to enhance the sustained availability of medicines, as recommended in the EU Competitiveness Compass. Selecting the proper criteria will be essential to not self-inflict unintended consequences of risk to supply and shortages, but to protect patients access to a broad portfolio of high-quality treatments. MEAT criteria should consider supply chain resilience including supply chain reliability (demonstration of locally established teams to address out of stock situations, past supply track record, inventory policy, capacity to mitigate OOS through product relocation), as well as incentives for a diversified supplier base, rather than favoring local production.Appropriate, science-based, and harmonized environmental procurement criteria can help advancing the EUs green agenda while ensuring availability of medicines. To reflect best practices while supporting diverse global supply chains, Viatris recommends incorporating the following criteria: companywide greenhouse gas reductions targets approved and validated by the Science Based Targetsinitiative, the acceptance of globally applied standards to report out on company level GHG emissions data across scope 1, 2 and 3 (e.g., GHG protocol, the CDP), transparency on waste reduction, responsible water use, AMR mitigation, and corporate supplier evaluation measures. Also, implementation should encourage participation by awarding additional points for non-price criteriasuch as new product features (VAM). 2. Multi-winner tenders should be preferred to mitigate supply risks.A single-winner tender model increases the risk of supply chain disruptions, particularly when few manufacturers exist for a given medicine. Multi-winner tenders should be preferred, considering market, product, volume predictability and country-specific characteristics. This approach will maintain a competitive landscape while mitigating the risk of shortages. 3. Penalties for shortages should be proportionate to contract value.Excessive penalties for medicine shortages in procurement contracts discourage manufacturer participation, especially in low-value, low-volume tenders for medically essential medicines. Some penalties equate to a manufacturers annual revenue or result in exclusion from future tenders, creating significant financial risks. Penalty structures should be proportionate to the contract value, capped at a defined percentage of the tender value. Tenders should also allow MAH to adjust prices over time, to reflect cost changes related to inflation or other economic factors, or transfer of the contract to other MAH to ensure proper contract execution. 4. A medicines-specific procurement framework should be established.To ensure that the revision of the PPD effectively addresses the unique challenges of medicines procurement, it should: recognize the distinct characteristics and requirements of medicines procurement, introduce targeted solutions that reflect the strategic importance of medicines supply and empower the EC to issue a delegated act outlining rules specifically designed for the medicines sector, ensuring that procurement frameworks support long-term availability, sustainability, and security of supply.
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Response to Critical Medicines Act

27 Feb 2025

Viatris is a global healthcare company, uniquely positioned to bridge the traditional divide between generics and brands, with a robust supply chain designed to reach 1billion patients globally. We are one of the main providers of critical medicines in European markets, supplying approximately half of the 216 molecules listed on the EU Critical Medicines List. We are also one of the largest suppliers of off-patent medicines across Europe, delivering 140 million packs of critical medicines in the EU in 2023 alone. Within critical medicines, our diverse portfolio spans 11 major therapeutic areas, contributing significantly to access to medicines in the region. We welcome the Commissions ongoing preparation of the Critical Medicines Act as a key opportunity to strengthen supply security, diversify supply chains and improve access to critical medicines across Europe. We support the proposal to promote thoughtful solutions that build a more resilient, sustainable and viable market environment in the EU, for both manufacturing and distribution of medicines. The proposal should reflect the global and extensive nature of pharmaceutical supply chains. We believe that secure, reliable access to medicines is best supported by a diverse and agile global supply chain designed to respond quickly to evolving needs. No country can make every medicine it needs, and no medicine is made in every country. To enhance competition and diversify suppliers in Europe and beyond, we recommend leveraging free trade agreements and procurement policies compliant with WTO principles as effective tools for improving supply chain resilience. Protecting patient access is essential, but national stockpiling is not the answer to promote regular supply in the market. The proposal should avoid unilateral and costly measures, such as national stockpiling and forced localization, that undermine access across Europe. We support measures to (1) encourage diversified manufacturing and sourcing, (2) increase demand predictability for Marketing Authorisation Holders (MAH) and (3) prevent disproportionate penalties to MAH. We support solutions to improve critical medicines market measures. Procurement systems can have a direct impact on supply security and can endanger it by contributing to market consolidation and reducing medicines economic viability. We welcome improvements to existing procurement rules that strengthen supply security, ensure patient access to life-saving medicines, and support the EUs goals around environmental sustainability and supply resilience. We support the shift from price-only tender criteria to the Most Economically Advantageous Tender (MEAT) procurement model. Selecting the proper criteria will be essential to prevent unintended consequences of risk to supply and shortages, while safeguarding patients access to medicines. The Critical Medicines Act is a unique opportunity to address current regulatory challenges and create a future-proof regulation that supports digitalization. Current regulatory requirements for critical medicines add complexity to supply chains and cost, such as country specific packaging and labelling. We recommend harmonizing pack formats and introducing electronic patient leaflets to reduce manufacturing complexity and increase movement between countries in the event of disruptions. Additionally, we support the simplification of shortage reporting to reduce cost and complexity, facilitating quicker responses and more effective coordination between industry, regulators and healthcare providers. The proposal should consider the impact of increasing obligations for MAH under pharmaceutical, chemical and environmental legislations with respect to the economic viability and availability of critical medicines. We call for striking a careful balance between ensuring access and imposing new requirements on pharmaceutical companies.
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Response to Evaluation and revision of the general pharmaceutical legislation

8 Nov 2023

Viatris is a global healthcare company, uniquely positioned to bridge the traditional divide between generics and brands, with a European portfolio comprising more than 1,400 approved molecules across all major therapeutic areas. Annually, Viatris supplies 36.8 billion doses of medicine in Europe, contributing significantly to equitable access to medicines in the region. Viatris welcomes the Commission intention to review the pharmaceutical legislation as a unique opportunity to advance equitable access to medicines, while creating the conditions for a predictable, resilient, and future-proof pharmaceutical market. As a pharmaceutical company committed to advancing access to medicines, Viatris acknowledges the European Commission's initiative to review and revise the pharmaceutical legislation to address the growing issue of medicine shortages. We share the Commissions concern and note that evidence shows many shortages are localized at national level and are driven by regulatory complexity and current market dynamics, including rising inflation rates, escalating input costs for medicine manufacturing and supply, and national pricing and reimbursement practices. To effectively tackle medicine shortages, its essential to implement a holistic action plan that encompasses various critical measures, including the implementation of MEAT procurement criteria to secure the sustainability of the off-patent market; and a feasible shortage prevention strategy that identifies a unified list of Critical Medicinal Products and leverages existing IT tools and data, including the European Medicines Verification System. We call for a balanced approach to shortage reporting and notification requirements that enables timely information for authorities while avoiding false alarms that may disrupt the market. Manufacturers should be able to notify authorities of temporary disruptions anticipated in the supply chain no more than three months in advance, with exceptions made for unforeseen circumstances, and shortage mitigation plans should only be required for critical medicines to avoid putting excessive burden on companies. Furthermore, its important to recognize economic root causes of medicines shortages as a reason to withdraw market authorization, as this information can enable identification of effective solutions. We support the changes introduced in the regulation that allow for the optimization and simplification of regulatory operations, including the introduction of a shortened market authorization approval time from 210 to 180 days. However, maintaining flexibility in choice of regulatory procedure for approval of follow-on medicines (including continued access to Centralized Procedure) is essential to enable continued patient access. The review of the pharmaceutical legislation is a unique opportunity to address current AMR challenges and create a future-proof regulation that supports access to high-quality antimicrobials and reduces inappropriate use of antimicrobials through a multistakeholder approach. The legislation should support availability of existing antimicrobials, by (1) providing regulatory flexibility in packaging, (2) introducing packaging harmonization and multilingual packages; (3) excluding existing antimicrobials from regulatory fees, as well as IRP and claw-back mechanisms; (4) fast-track market approval to accelerate market entry of new suppliers for existing antimicrobials; (5) introducing new pricing and procurement models that support access, competition, and value companies CSR commitments and security of supply. Viatris is committed to working collaboratively with the European institutions and other stakeholders to ensure that the pharmaceutical legislation strikes the right balance between fostering innovation and enabling access to medicines.
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Response to Evaluation and revision of the general pharmaceutical legislation

8 Nov 2023

Viatris is a global healthcare company, uniquely positioned to bridge the traditional divide between generics and brands, with a European portfolio comprising more than 1,400 approved molecules across all major therapeutic areas. Annually, Viatris supplies 36.8 billion doses of medicine in Europe, contributing significantly to access to medicines in the region. We welcome the Commissions intention to review the pharmaceutical legislation as a unique opportunity to advance equitable access to medicines, while creating the conditions for a predictable, resilient, and future-proof pharmaceutical market. We stress the importance of predictability and legal certainty for manufacturers to enable timely and equitable access to medicines, which can be achieved only with a well-functioning competitive market. Viatris supports the simplification of the regulatory environment, recognizing the significant potential for digitalization in improving coordination among Member States and European Institutions. We believe that the revision of legislation should prioritize: 1. The digitalization of the medicines network based on the interoperability of medicines agency systems to enable timely collection and analysis of regulatory data on authorized medicines. It should accelerate the automated exchange of regulatory data, optimize regulatory processes, expedite the development of digital- telematics infrastructure to link regulatory and supply chain data for all medicines, and establish the foundation to implement and expand the use of electronic product information (ePI). 2. The swift transition to the ePI, promoting easier access to digital information and flexibility for manufacturers to address unexpected demand surges across the EU and secure timely access to medicines. Value added medicines, improvements to existing molecules including repurposing, can serve as an accessible type of innovation to address unmet health needs, relieve burden on health systems and contribute to better quality of life for patients. To ensure the applicability of the Directive provisions for these medicines, we recommend to (1) clarify the article to include all changes brought through repurposing, (2) align to the concept of significant benefit in the orphan legislation which recognizes patient centered benefits, (3) future-proof the legislation by referring to both non-clinical and clinical evidence, (4) link the data exclusivity to the concept of global market authorization to avoid evergreening practices, and (5) clarify the article to specify dossier requirements and eligibility of data protection on combinations, and add posology for hybrid application. Viatris welcomes improvements in delinking the food and pharmaceutical legislations to secure a mechanism for a special risk assessment tailored to medicines that adequately considers the need to maintain patient access to medicines. Considering the current horizontal regulatory trends, the proposal should add the same approach to any other legislation that might indirectly challenge the use of certain excipients or group of chemical compounds used in medicines. The European Medicines Agency should be responsible for taking a scientific decision every time any excipient used in pharmaceuticals is examined by horizontal legislations. We encourage a pragmatic approach to the environmental risk assessment (ERA), which makes the most efficient use of limited resources and reduces risk to the environment from medicines post use, while respecting the EU proportionality principle. We support the proposal on the ERA that allows off-patent products to reference the data of the originator, avoiding delays in access to generic medicines in the future. For medicinal products authorized before 30 October 2005 that have not been subject to any ERA (legacy medicines products), there should be a clearer focus on medicines presenting the highest risk to the environment.
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Meeting with Elina Melngaile (Cabinet of Executive Vice-President Valdis Dombrovskis), Zaneta Vegnere (Cabinet of Executive Vice-President Valdis Dombrovskis) and

5 Jun 2023 · Trade & Technology Council, Global Steel and Aluminum Arrangement, Critical Minerals Agreement

Response to Review of the requirements for packaging and feasibility of measures to prevent packaging waste

24 Apr 2023

Viatris is a global healthcare company, supplying 36.8 billion doses of medicine annually in Europe. Our portfolio comprises more than 1,400 approved molecules across a wide range of therapeutic areas, spanning generics, complex generics, and branded medicines. We work diligently to reduce our environmental impact and advance sustainable practices while meeting the highest regulatory standards around the world and ensuring the quality, safety, and reliable supply of medicines. Viatris is aligned with Medicines for Europes position on the review of the Packaging and Packaging Waste Directive, which is an opportunity to reduce packaging waste and harmonize packaging requirements across the single market. While we welcome the presence of provisions specific to medicinal products and medical devices, we note that some of the measures do not fully reflect relevant regulatory complexities, namely: 1. Requirements for packaging, including parameters that impact recyclability, and labelling for pharmaceutical products are governed by health and regulatory authorities and should not be pursued in silos, as this could cause duplication or conflicting requirements. 2. The introduction of new packaging and labelling requirements for pharmaceutical products could have a significant cost to ensure the stability of the product and assess contamination threats. The cost and time required to make such changes could jeopardize the availability of some products, risking access to medicines; and 3. The lack of a regulatory pathway to guide manufacturers in implementing these changes. Therefore, Viatris offers the following recommendations to protect patients access to medicines, ensure product quality and safety, and reduce the environmental footprint: 1. The facilitation of the removal of the paper Patient Information Leaflet and transition towards electronic product information to enable packaging minimization (Article 9). - Leveraging digital transformation will further allow packaging material minimization (reduction of the overall size of packaging), reduce packaging waste, and support more efficient transport and storage. 2. The harmonization of requirements for outer packaging by a cross-reference to the pharmaceutical legislation - Directive 2001/83 (Article 13). - The requirement to add more information in the outer packaging can be complex and confusing due to existing requirements for medicine packaging and space limitations (especially in existing multilingual packages). 3. An exemption from the labelling (Articles 11, 13) and recyclability (Article 6) requirements for immediate packaging extending beyond 2035. - From a technical point of view, requiring additional labelling information on the immediate packaging is not feasible because of limited space and existing mandatory regulatory information. - The direct contact of recycled material with the active pharmaceutical substance can pose a real threat of contamination and could potentially jeopardize the quality of the product. In addition, the research and potential packaging changes that may be required, would be extremely costly and could disrupt the supply of generic products. 4. The harmonization of pack sizes of medicinal products for chronic diseases in Europe. 5. Coordination with the European and national medicine regulatory authorities to streamline the regulatory processes. - By establishing an upfront regulatory guidance defining the implications of the changes to medicine packaging and additional labelling, companies will be better prepared to adapt to and implement the Directive, especially those with large portfolios. 6. The establishment of a clear transition period to avoid the need to discard pharmaceuticals entering the market prior to the Directives entry into force.
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Response to Revision of the Urban Wastewater Treatment Directive

13 Mar 2023

Viatris is a global healthcare company with a European portfolio comprising more than 1,400 approved molecules across a wide range of therapeutic areas, spanning generics, complex generics and branded medicines. Annually,Viatris supplies 36.8 billion doses of medicine in Europe. We are fully committed to protecting the environment, while safeguarding a reliable supply of medicines. We work to address the presence of pharmaceutical residues in the environment by implementing internal environmental policies and management systems that guide all our operations to protect the environment and human health, implementing appropriate controls, technologies and containment strategies, in our treatment of wastewater. Also,we have established ambitious science-based climate and water risk assessment targets. Viatris is aligned with Medicines for Europes position on the proposal to revise the Urban Wastewater Treatment Directive (UWWTD). The review of UWWTD is an opportunity to upgrade the quality of EU waterbodies and protect the environment and the health of European citizens. However,the current proposal is based on a feasibility study that does not establish the necessary scientific evidence to justify some of the provisions, and places disproportionate responsibility on the pharmaceutical sector, risking patients access to medicines. The extrapolation of data from regions in just two countries to the whole EU, as was done for example to estimate the presence of harmful substances in waterbodies, can result in inaccurate conclusions that are not representative of the EU reality. Furthermore, the lack of thorough assessment of the contribution of other sectors to the presence of micropollutants in water is unjustified. Progressing with the proposed Directive would contradict several provisions of the EU pharmaceutical legislation. Pharmaceutical APIs are intensively researched over a lengthy development phase and are obliged to go through an Environmental Risk Assessment, where most APIs are shown to cause no unacceptable risk for the environment when used by patients.Furthermore, the feasibility of replacing current medicines with alternative molecules is not sufficiently addressed in the impact assessment; no evidence is presented to demonstrate the feasibility of replacing APIs without comprising patient safety and efficacy. There is also a significant underestimation of the impact this Directive will have on the off-patent pharmaceutical sector, which supplies 70% of prescribed medicines in Europe and represents only 30% of market value. This sector enables access to affordable, safe, effective medicines for patients across Europe, and has much lower profit margins relative to originator products. On average, producers would need to contribute over 10% of products ´ sales value to pay for the 80% of the funds to be collected from the pharmaceutical sector. Moreover,for some of those molecules, the EPR fee would exceed the total annual sales revenue of the product in question. Viatris is fully committed to maintaining patients access to medicines in Europe and is therefore concerned that the current proposal risks significantly curtailing this access. By basing fee calculations on product volume, the proposed Directive will disproportionately impact the off-patent sector and adds to the already unsustainable market conditions for off-patent medicines given current high levels of inflation coupled with restrictive national pricing regulations. Implementation of the proposed Directive in its current form could threaten the viability of certain products and cause an acceleration in the withdrawal of certain off-patent medicines from the market. Finally,we would like to highlight the importance of constant dialogue and cooperation between the Commission and different stakeholders, including industry. Exchanges between all parties involved are essential to protect waterbodies, the environment and ensure everyones right to health.
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Response to A European Health Data Space

28 Jun 2022

VIATRIS is committed to providing access to medicines, advancing sustainable operations, and developing innovative solutions to improve patient outcomes. Our portfolio comprises more than 1,400 molecules across major therapeutic areas including brand medicines, generics, OTC medicines, and APIs. We appreciate this opportunity to review the European Health Data Space proposal through a lens of assessing its potential impact on patient access to medicines. Off-patent medicines play a vital role in our health care system by ensuring that life-saving medicines are widely available. The effectiveness of off-patent competition at improving access to medicine and healthcare system value is well established: the vast majority, almost 70%, of dispensed medicines in Europe are generic, yet they account for less than 30% of pharmaceutical expenditure. We are encouraged by the potential direct and indirect benefits to patients. However, implementation of the EHDS must consider sustainability of the off-patent medicines industry. Considering the needs only of the on-patent sector in implementing the EHDS could unintentionally undermine the benefits brought by off-patent medicines. STAKEHOLDER ENGAGEMENT We anticipate that implementing the EHDS will create numerous new opportunities and challenges, many of which are not yet known. Stakeholders across the ecosystem should be engaged early and often to identify and mitigate any unintended consequences of the EHDS, particularly those that could jeopardize the supply of essential medicines or off-patent competition, immediately or in the future. IMPACT ON REGULATORY FRAMEWORK The availability of data arising from the EHDS will open new avenues for collective evidence toward authorizing new medicine products. Any changes to regulatory frameworks arising from these new tools should be science-based, and seek to streamline the medicine approval process, including through consideration of impact on off-patent competition. Efficiency gains, rather than additional requirements that could delay the availability of new medicines, must be prioritized. DATA ACCESSIBILITY Industry access to big data has not always been equitable. Off-patent manufacturers are often unable to invest in expensive databases for development of off-patent medicines since budgets must be stretched across wide-ranging portfolios of low-margin products. The use of big data can be an important tool in the development of “value-added medicines,” or VAM. VAM refers to incremental innovation on existing medicines, filling patients’ unmet needs at a far lower cost than the development of brand-new drugs. To maximize the public health benefit of data research, EHDS and data access bodies should be set up in a way that ensures equitable access to the health data, without excessive costs or hurdles. DATA FLOWS In scientific research on secondary uses of data, data analysis often occurs outside of Europe, reflecting the global interconnectivity of medicines development. The off-patent industry has narrow margins, and it is important to use cost-effective research practices to maximize the utility of data. The EHDS should not place restrictions on data flows that would hinder timely and efficient data analysis, such as restricting data flows to countries outside of Europe, or countries falling outside of the EU’s framework for adequacy decisions, as defined in the General Data Protection Regulation. INDUSTRY’S ROLE IN IMPLEMENTATION AND MAINTENANCE Implementation of the EHDS will require new investments and changes in practices by stakeholders across the healthcare ecosystem. Operating margins in the off-patent industry are already thin due to competition, making the industry sensitive to uncompensated additional costs. Any additional responsibilities placed on industry for the implementation and/or maintenance of the EHDS should be balanced against considerations for access and availability of off-patent medicines.
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Response to Recommendation for strengthened actions against antimicrobial resistance

24 Mar 2022

Many factors contribute to AMR, including poor infection control and over-prescribing of antibiotics. To fight AMR while ensuring patient access to life-saving medicines, the EC should consider the following evidence-based reforms: 1. Appropriate Use AMR is slowed when: • patients and HCPs understand the risks, use antibiotics only when necessary • adhere to courses of treatment until complete. • early diagnosis can prevent the need for an antibiotic. 2. Cross Industry Collaboration to Tackle AMR The industry is working together through the AMR Industry Alliance (AMRIA) on sustainable and holistic solutions to combat AMR by: • Engaging members to promote responsible wastewater and effluent management. • Enhance access to and appropriate use of antibiotics. • Promoting innovative responses to infectious diseases. AMRIA’s core projects include the Common Manufacturing Framework. Most antibiotics in the environment are due to human and animal excretions, and a significantly smaller amount is from pharmaceutical manufacturing. Recognition for compliant companies, such as including compliance with the industry standard as a criterium for procurement, will encourage investment in appropriate effluent management and create a level playing field for environmentally responsible manufacturing. 3. Market Reforms to Avoid Consolidation and Shortages Antibiotics are largely off-patent, multi-source products, meaning prices are already low due to market competition. Despite this, antibiotics face downward price pressure, leading to a tough market environment for older, yet essential antibiotics. In many countries, antibiotic pricing and procurement are unsustainable for manufacturers, resulting in market consolidation, increasing the risk of shortages. Therefore, the following reforms are needed: • Pricing policies should ensure a healthy market competition, allowing patients to have access to a broad range of antibiotics. • Procurement should consider criteria other than price (MEAT criteria) to ensure the best value for money. Furthermore, if tenders are used, multi-winner tenders should be implemented to guarantee multiple manufacturers in the market. • To reduce single sourcing and dependency it is critical to encourage a global and diverse supply chain as well as different antimicrobial pack sizes. • Newer models (such as advanced market commitments, antimicrobial subscriptions etc.) are needed to encourage development. 4. Support for Value Added Innovation Research in existing molecules with anti-microbial activity should complement efforts put into discovery of new antibiotics. A broad set of antibiotics allows healthcare providers to choose the optimal antibiotic. Repurposing off-patent molecules with a known antimicrobial activity should be promoted. Improvements can be achieved by optimising delivery and adapting existing treatments and mitigating the overuse that contributes to AMR. Currently, investment in this kind of R&D is disincentivised in the EU. To support cost-effective innovation, the concept of Value-Added innovation should be defined in the EU pharmaceutical legislation. 5.Risk of Introducing Transferable Exclusivity Vouchers in Europe We oppose additional post-authorisation incentives, especially via transferrable exclusivity vouchers, which extend monopolies for non-antimicrobial drugs, increasing costs for healthcare budgets, adding to legal uncertainty and delaying access to generics/biosimilars. No jurisdiction worldwide has transferable exclusivities; Europe should not be the first to open the door for this practice. An analysis by the TATFAR describes the price of a “voucher” as “high, and an inefficient mechanism for promoting innovation,” with “negative impact on patient care.”
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Response to Food safety – restrictions on the use of monacolins from red yeast rice in foods

17 Jun 2021

VIATRIS is a healthcare company, formed in 2020 through the combination of Mylan and Upjohn – a legacy Pfizer division, committed to providing access to medicines, advancing sustainable operations and developing innovative solutions to improve patient outcomes. Our European portfolio comprises more than 1,400 molecules across all major therapeutic areas including innovative medicines, branded and complex generics, growing portfolio of biosimilars and a variety of over-the-counter consumer products. Viatris is also an important player in the food supplement area, with high quality standards products, based on natural ingredients, that can help people to maintain healthy status. Our company has been marketing products containing 3mg of Monacolin K since 2004 and does so in 25 countries worldwide (EU and non-EU), with around 700 million intake days experience with these products. We continuously and proactively monitor the safety of products. We welcome the opportunity to provide feedback on the public consultation concerning Monacolins from Red Yeast Rice. Our feedback is aligned with the submission of the European Federation of Associations of Health Products Manufacturers to this consultation. Our main comments to the “Proposal for an EU Regulation amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards monacolins from red yeast rice (Draft regulation SANTE/10408/2020)” are described with rationale in the pdf attached. In addition, we would like to provide executive summary of the key points below: 1. The definition of “Restricted Substance” and “Conditions of use” under Annex III Part B in the proposed Regulation Amendment should refer to “monacolins (monacolin K) from red yeast rice” and not to the generic and potentially misleading word “ monacolins from red yeast rice”. 2. Monacolins (monacolin K) should be understood and defined as the sum of monacolin K lactone and monacolin K hydroxy acid. 3. The Conditions of use stated in Part B of Annex III of the Regulation Amendment should be amended to refer to an individual portion of food or food supplement for daily consumption of not more than 3 mg , allowing the stakeholders to present new further post-market surveillance data based on consumption in the next years of the above mentioned dosage. 4. The label requirement “Should not be consumed by […] adults above 70 years old” should be deleted from the “Additional requirements” listed under Annex III Part B of the Regulation Amendment. In conclusion, we believe that these comments are providing reasonable clarifications to the current draft amendment to the regulation and that if these points are reflected in the future regulation, it would not jeopardize access to alternative health interventions, but it will protect safety of the consumers based on scientific evidence.
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Response to Evaluation and revision of the general pharmaceutical legislation

27 Apr 2021

VIATRIS is a new healthcare company, formed in 2020 through the combination of Mylan and Upjohn. We are committed to providing access to medicines, advancing sustainable operations and developing innovative solutions to improve patient outcomes. Our portfolio comprises more than 1,400 molecules across major therapeutic areas including brand medicines, generics, OTC medicines, APIs and one of the industry´s largest biosimilar portfolios. The review of the pharmaceutical legislation provides an opportunity to reflect on competition considerations impacting patient access to generic and biosimilar medicines. Revision of the legislation could tackle misuses of the system that delay competition, such as harmonising and extending the scope of the Bolar exemption and banning patent linkage, thereby fostering patient access to off-patent medicines on day one after expiry or invalidation of IP protections. As it pertains to the revision of incentives that promote innovation throughout the medicine lifecycle, we would like to emphasise the great potential incremental innovations to known molecules has in providing solutions for unmet medical needs. A new legal provision establishing a Value Added Medicines (VAM) fit-for-purpose regulatory framework including recognition of VAM as a separate category of innovation should provide proportionate incentives resulting in timely and affordable patient-centric innovation. Unsustainable market conditions are causing companies to withdraw certain off-patent and effective antibiotics (Abx) from the market and/or reducing their portfolio, which hamper patient access to optimal treatments. The below measures are especially apt for ensuring access to Abx, but can be applied beyond Abx: - prevent future market exit by providing targeted regulatory simplification for MAHs of critical Abx through decreased cost of maintaining market authorisation. - optimise the regulatory pathway for older Abx that have previously been unavailable in some or all European markets and provide incentives by means of reduction in regulatory fees for MA applications. - introduce new pricing models that guarantee economic viability of these products. The EU needs to remain competitive in the global pharmaceutical system, and efficiency in the regulatory environment can play a large role, including through optimizing the IT infrastructure. The implementation of telematics tools should ensure that regulatory data is submitted only once (Target Operating Model [TOM]), thereby removing the need for national portals and reducing administrative burden on companies and authorities. In addition, we strongly support timely implementation of e-leaflets for pharmaceutical products. To address medicine shortages, supply chain resilience should be strengthened via procurement reforms that includes criteria other than price and encourages multiple manufacturers to supply the market. Imposing stronger obligations to supply and subsequent penalties will increase the cost burden on manufacturers and will mean more products economically unviable. Any stockpiling of medicinal products must be done rationally: taking into account clear demand, financing and management of the stockpile, and preventing strain on manufacturing capacities and potential wasteful disposal of unused medicines. Uncoordinated national stockpiling demands should be rejected as this will fragment the internal market, increase costs and undermine EU solidarity. As part of enhancing the environmental sustainability of manufacturing and disposal of medicines, there is a need for greater reliance on science to inform effective risk-based polices. Leveraging established industry initiatives and promoting incentive systems would facilitate the scaling up of good conduct while supporting healthy competition and a stable supply of affordable high-quality medicine. Finally, increasing biosimilar medicines use will deliver major health outcomes for patients across Europe.
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