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Teva Pharmaceuticals Europe BV

Teva

Teva is a global generic pharmaceutical company specializing in development, production and marketing of generic and branded medicines.

Lobbying Activity

Meeting with Michele Piergiovanni (Cabinet of President Ursula von der Leyen)

12 Nov 2025 · Payment of fines in AT.39686

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

17 Oct 2025 · Review of the EU General Pharmaceutical Legislation

Meeting with Tomislav Sokol (Member of the European Parliament, Rapporteur) and Vaccines Europe

24 Sept 2025 · Health policy

Meeting with Jeannette Baljeu (Member of the European Parliament)

18 Jul 2025 · Critical Medicines Act and urban wastewater treatment

Meeting with Michele Piergiovanni (Acting Director Competition) and

10 Jul 2025 · Exchange of views on the pharmaceutical sector and on competition policy enforcement

Response to Critical Medicines Act

4 Jul 2025

Teva is a strategic partner of EU healthcare systems, producing 96% of its European generic, biosimilar, and innovative portfolio in plants across 13 European countries. In 2024 alone, Teva saved healthcare systems more than 3.4 billion USD across 17 European countries, supporting over 104,000 jobs. When it comes to critical medicines, Teva supplies 42% of the medicines listed on the Union List of Critical Medicines, with 70% of those produced across 11 European manufacturing sites. The Critical Medicines Act is a once-in-a-generation opportunity to strengthen Europes health sovereignty. Teva calls for bold, coordinated EU action to build a resilient, secure, and sustainable supply system for critical medicines. Teva welcomes the European Commissions initiative on the Critical Medicines Act and urges decisive action to secure the availability of essential medicines across Europe. Recent crises have exposed the fragility of medicine supply chains, particularly for critical generics. To address these challenges, Teva proposes a three-pillar strategy: Procurement Reform: Shift from price-only tenders to multi-criteria procurement that rewards reliability, sustainability, and contribution to the European economy. Avoid over-reliance on joint procurement except in emergencies. Coordinated Stockpiling: Establish a European Solidarity Mechanism to reallocate existing stocks and avoid fragmented national stockpiling. Use real-time tools like the EMVS and enable regulatory flexibilities to improve cross-border supply. Strategic Funding: Create a one-stop shop for EU-level funding to support advanced manufacturing and reduce external dependencies. Recognise critical medicine production as a pillar of EU resilience and defence. Our full position is attached to this submission for further details and reference.
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Meeting with Mohammed Chahim (Member of the European Parliament, Shadow rapporteur for opinion) and European Federation of Pharmaceutical Industries and Associations and

25 Jun 2025 · Roundtable Critical Medicines Act

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

14 May 2025 · Critical Medicines Act

Meeting with Andreas Glück (Member of the European Parliament, Shadow rapporteur for opinion)

14 May 2025 · Critical Medicines

Meeting with Oliver Schenk (Member of the European Parliament)

14 May 2025 · Pharmaceutical Industry in the EU

Response to EU Strategy on medical countermeasures

9 May 2025

Teva is a strategic partner of EU healthcare systems, producing 96% of its European generic, biosimilar and innovative portfolio in plants across 13 European countries. In 2023, Teva saved the healthcare systems more than 2.9 billion EUR across 13 European countries, in which we support more than 120,000 jobs. Stockpiling of medicines is not a silver bullet to securing the availability of medical countermeasures against public health threats. First, it is crucial to address the economic root causes of the supply chain vulnerabilities while engaging all of the stakeholders to build a robust supply chain framework that is ready for any future public health threats. At the moment, we witness the European countries implementing inefficient and market-distorting national safety stock obligations. Unfortunately, these measures have the opposite effect on the availability of medicines as the supply chain is often operating at its full capacity, and it is not possible to manufacture for stockpiling without risking disruption of supply to other countries. Therefore, a crucial part of any stockpiling strategy is to evaluate all of the current national safety stock obligations to MAH and how these could be optimised and transformed to create a harmonised pan-European reserve stock. A common and standard definition of stockpiling should be implemented at the European level, assuring mutual understanding and interpretation, like many other shortage definitions that have been built and developed in the last years by the involved actors. European reserve stock should supersede any national stock and it should be seen only as a last-resort backup mechanism, to help absorb a limited time of clinical demand to allow the supply chain to adapt to the situation and activate additional measures to prevent supply disruption. As such it must be targeted (i.e. based on a risk assessment to determine medicines or therapeutic focus areas) and proportionate (i.e. the size of the stockpile should be defined based on the situation for which the stockpile is foreseen and a rational forecast per product to avoid overstocking and unnecessary destruction of medicines). Taking into account these two principles, the stockpile should be limited to these specific cases: 1) preparedness for a public health emergency or other large-scale crisis, and 2) in case of products on the Union List of Critical Medicines with major therapeutic interest and minimal therapeutic alternatives, where stockpiling is identified as a prevention or mitigation option by the risk assessment. Any reserve stock must be appropriately funded (in case of publicly held physical stockpiles) or remunerated (in case of privately held physical stockpiles or virtual stockpiles), with the ownership framework clearly defined, and coordinated by the Commission. The stockpiled medicines must freely move between the countries, to fully utilise the Solidarity Mechanism, which would be facilitated by regulatory flexibilities. This includes using universally sized and multilingual packages and using electronic product information as the main source of product information. From our experience with the Solidarity Mechanism, the procedure to obtain import license usually takes several weeks and is not harmonised among the countries. Given that medicines have a limited shelf life, wasteful destruction is a major drawback of any stock holding. The regulatory authorities should work with the manufacturers of the stockpiled medicines to prolong the shelf life as safely as possible, to prevent the waste of the medicines, while optimising stock management. The stockpiling strategy must be supported by sufficient investment and cooperation with industry on the digitalisation of regulatory data systems (EU and nationals) and interoperability with other relevant systems (i.e., European Shortage Monitoring Platform ESMP and European Medicines Verification System EMVS).
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Response to Communication on the EU Stockpiling Strategy

9 May 2025

Teva is a strategic partner of EU healthcare systems, producing 96% of its European generic, biosimilar and innovative portfolio in plants across 13 European countries. In 2023, Teva saved the healthcare systems more than 2.9 billion EUR across 13 European countries, in which we support more than 120,000 jobs. Stockpiling of medicines is not a silver bullet to solve the current vulnerabilities and disruptions of the supply chain. First, it is crucial to address the economic root causes of the vulnerabilities, while engaging all of the stakeholders to build a robust shortage response and management framework based on solidarity between countries and the competitiveness of the industry. At the moment, we witness the European countries implementing inefficient and market-distorting national safety stock obligations. Unfortunately, these measures have the opposite effect on the availability of medicines as the supply chain is often operating at its full capacity, and it is not possible to manufacture for stockpiling without risking disruption of supply to other countries. Therefore, a crucial part of any stockpiling strategy is to evaluate all of the current national safety stock obligations to MAH and how these could be optimised and transformed to create a harmonised pan-European reserve stocks framework. A common and standard definition of stockpiling should be implemented at the European level, assuring mutual understanding and interpretation, like many other shortage definitions that have been built and developed in the last years by the involved actors. European reserve stock should supersede any national stock and it should be seen only as a last-resort backup mechanism, to help absorb a limited time of clinical demand to allow the supply chain to adapt to the situation and activate additional measures to prevent supply disruption. As such, it must be targeted (i.e. based on a risk assessment to determine medicines or therapeutic focus areas) and proportionate (i.e. the size of the stockpile should be defined based on the situation for which the stockpile is foreseen and a rational forecast per product to avoid overstocking and unnecessary destruction of medicines). Taking into account these two principles, the stockpile should be limited to these specific cases: 1) preparedness for a public health emergency or other large-scale crisis, and 2) in case of products on the Union List of Critical Medicines with major therapeutic interest and minimal therapeutic alternatives, where stockpiling is identified as a prevention or mitigation option by the risk assessment. Any reserve stock must be appropriately funded (in case of publicly held physical stockpiles) or remunerated (in case of privately held physical stockpiles or virtual stockpiles), with the ownership framework clearly defined, and coordinated by the Commission. The stockpiled medicines must freely move between the countries to fully utilise the Solidarity Mechanism, which would be facilitated by regulatory flexibilities. This includes using universally sized and multilingual packages and using electronic product information as the main source of product information. From our experience with the Solidarity Mechanism, the procedure to obtain an import license usually takes several weeks and is not harmonised among the countries. Given that medicines have a limited shelf life, wasteful destruction is a major drawback of any stock holding. The regulatory authorities should work with the manufacturers of the stockpiled medicines to prolong the shelf life as safely as possible, to prevent the waste of the medicines, while optimising stock management. The stockpiling strategy must be supported by sufficient investment and cooperation with industry on the digitalisation of regulatory data systems (EU and nationals) and interoperability with other relevant systems (i.e., European Shortage Monitoring Platform ESMP and European Medicines Verification System EMVS).
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Response to Evaluation of the Public Procurement Directives

7 Mar 2025

Teva is a strategic partner of EU healthcare systems, producing 96% of its European generic, biosimilar and innovative portfolio in plants across 13 European countries. In 2023, Teva saved the healthcare systems more than 2.9 billion EUR across 13 European countries in which we support more than 120,000 jobs. We believe that the revised public procurement directives (PPD) must recognize the strategic importance of the pharmaceutical industry for European citizens. In the past three years, we have shown in a series of reports that the current procurement processes with a sole focus on the lowest price do not support competition and contribute to the decreasing economic viability of generic medicines. Recently, we have published a report, Generics Health Check 2025, showing that 83% of critical generic medicinal products are provided by a single supplier that covers over 60% of the market demand. One of the root causes for the current state is the price race to the bottom driven by tenders, in combination with an onerous business environment led by new regulations (e.g. UWWTD) and external dynamics (e.g. high energy prices & inflation). This environment is challenging the economic viability of generic medicines, reducing the competition and consequently leading to supply consolidations. The high degree of supplier consolidation leads EU markets to rely on a single major supplier. In case of supply disruption coming from the major supplier, the minority suppliers left on the market can't step up and fill the gap, leading to medicine shortages and impacting patients access to their medication. The current European Public Procurement Directive introduced the concept of the Most Economically Advantageous Tender (MEAT) criteria, but the Member States did not fully implement it as they lacked a clear legal framework to implement it efficiently. Designing a well-performing procurement system for medicines is crucial to achieving an economically viable, diverse and competitive market, preventing medicines shortages and securing Europes strategic autonomy. Teva believes that the procurement process design can be optimized by: 1) adjusting the number of procurement winners, creating opportunities to support a diverse supply chain; 2) fully implementing award criteria that consider other factors than price and ensure fair competition. These criteria must not be seen as a prerequisite to participation in public procurement but rather as reward criteria to stimulate investments in the EU economic transformation. Criteria beyond price should include both environmental and security of supply adapted to the generic business model. Therefore, environmental criteria should capture the corporate approach to sustainability supported by public commitments and certifications rather than a product-by-product approach like a life cycle assessment, which would challenge the economic viability of generic medicines. On the security of supply criteria, the suppliers should be rewarded for taking steps that strengthen the supply of medicines, such as past evaluating supply performance. 3) recognising products with a European supply chain, for example, via a designated award slot for European producers. Adding a criterion based on European preference would help to address some of the geopolitical uncertainties and stimulate investments in strategic industries such as the pharmaceutical industry. However, this preference should not undermine the Single Market by allowing nationalistic procurement requirements, as well as respect the global nature of the pharmaceutical supply chain. Lastly, the non-price criteria should recognize and reward the supplier's overall contribution to the European economy.
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Meeting with Andreas Glück (Member of the European Parliament)

4 Mar 2025 · CMA

Response to Critical Medicines Act

27 Feb 2025

Teva is a strategic partner of Europes healthcare systems, producing 96% of its generic, biosimilar and innovative portfolio in 13 member states in which we support more than 120,000 jobs. Our portfolio covers 42% of the medicines on the Union List of Critical Medicine, of which 70% are still produced in Europe. Teva is an active member of the Critical Medicines Alliance, and we believe that the Critical Medicines Act is a unique legislative opportunity to enhance the EU security of supply and manufacturing global competitiveness. Teva has been showing for the past three years with its series of reports, Generics Health Check, that the European generic medicines market is highly consolidated, creating significant supply vulnerabilities. Our latest report, published in February 2025, shows that 83% of critical generic medicines are supplied by a single supplier who covers over 60% of the market demand. This high consolidation is happening 3 times faster for critical generic medicines than other generics. The significant cost pressures from geopolitical tensions, new regulations, and the lack of price flexibility cause this situation. Since 2015, the harmonised index of consumer prices increased by 30%, while the Index of Critical Generic Medicines List Prices of the TOP 10 Generic Suppliers have seen only a 2% increase. This doesnt include cost-containment measures outside of the suppliers control, such as mandatory rebates or discounts and clawback/payback schemes. This economic environment leads to a dramatic consolidation of suppliers, the withdrawal of critical generic medicines and manufacturing offshoring. This alarming situation must be addressed by stimulating supply diversity and supporting Europes pharmaceutical manufacturing competitiveness. The Single Market must be strengthened and further harmonized. Distorting national initiatives, such as the proliferation of national stockpiling obligations, must be addressed. For many medicines, the European industrys production capacity has reached its maximum. It is not possible to produce and hold medicines due to excessive stockpiles in some countries without impacting the availability of medicines in other countries. The Act should enable the full implementation of the European solidarity mechanism underpinned by the electronic patient leaflet and a common European pack to strengthen the movement of goods across Europe to address shortages. The Act must also contain provisions to attract investments to enhance European production capacities and introduce predictable and well-targeted funding opportunities both by facilitating access to the existing financing tools as well as proposing novel funding frameworks. Today, only innovation focusing on a first-of-its-kind facility can potentially benefit from public funding. This must be extended to cover either new or substantially upgraded API or finished dosage form manufacturing facility, or a facility to produce other critical components. The diversity of critical medicines supply and the European manufacturing competitiveness must also be supported by reforming public procurement rules to systematically include non-price award criteria and multiple winners with a slot reserved for suppliers with European API or final dosage form production. Finally, we strongly believe the Critical Medicines Act must also safeguard critical medicines from the consequences of legislations that are massively threatening patients' access to critical medicines, such as the revised Urban Wastewater Treatment Directive.
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Meeting with Oliver Schenk (Member of the European Parliament)

27 Feb 2025 · EU Pharmastrategie

Meeting with Tiemo Wölken (Member of the European Parliament)

27 Feb 2025 · Critical Medicines

Meeting with Tomislav Sokol (Member of the European Parliament)

18 Feb 2025 · Health policy

Meeting with Laurent Castillo (Member of the European Parliament)

4 Dec 2024 · Europe de la Santé et médicaments génériques

Meeting with Jeannette Baljeu (Member of the European Parliament)

12 Nov 2024 · Medicijntekorten

Meeting with Ingeborg Ter Laak (Member of the European Parliament)

12 Nov 2024 · Medicines

Meeting with Daniele Polato (Member of the European Parliament)

23 Oct 2024 · Pharmaceuticals

Meeting with Ruggero Razza (Member of the European Parliament)

22 Oct 2024 · Incontro conoscitivo e scambio di vedute sul mandato del Parlamento europeo

Meeting with Pietro Fiocchi (Member of the European Parliament)

22 Oct 2024 · Carenza medicinali essenziali

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

22 Oct 2024 · Medicines

Meeting with Elena Donazzan (Member of the European Parliament)

21 Oct 2024 · Incontro tematiche farmaceutiche industriali

Meeting with Laurent Castillo (Member of the European Parliament)

3 Oct 2024 · Europe de la Santé

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

26 Sept 2024 · New EU Pharmaceutical Legislation

Meeting with Laura Ballarín Cereza (Member of the European Parliament)

23 Sept 2024 · Generic Medicines, Critical Medicines Act

Meeting with Margarita De La Pisa Carrión (Member of the European Parliament)

23 Sept 2024 · Pharma regulation

Meeting with Dolors Montserrat (Member of the European Parliament)

4 Mar 2024 · Revision of the pharmaceutical legislation

Meeting with Frédérique Ries (Member of the European Parliament, Shadow rapporteur)

1 Feb 2024 · Revision of the Pharmaceutical Legislation

Meeting with Nathalie Colin-Oesterlé (Member of the European Parliament)

29 Jan 2024 · Pharmaceutical review

Meeting with Frédérique Ries (Member of the European Parliament, Shadow rapporteur)

30 Nov 2023 · Revision of the Pharmaceutical Legislation

Teva seeks predictable incentives and streamlined drug shortage reporting

8 Nov 2023
Topic — EU revision of pharmaceutical laws to ensure drug affordability and supply security.
Message — Teva requests predictable incentives and opposes the 6-month advance notice for supply disruptions. They want shortage prevention plans limited to critical medicines to reduce administrative work.12
Why — Teva would face fewer regulatory hurdles and lower costs for manufacturing generic medicines.34
Impact — Regulatory agencies might have less time to address and resolve medicine shortages.5
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Teva Pharmaceuticals Urges Predictable Incentives and Faster Generic Entry

8 Nov 2023
Topic — The EU is revising pharmaceutical laws to improve medicine affordability and foster innovation.
Message — Teva calls for a predictable incentive system that ensures the day-one launch of generic medicines. They advocate for a more inclusive definition of medical needs and digital patient leaflets. They also oppose revoking drug authorizations based on environmental risk assessments.123
Why — This would reduce Teva's regulatory compliance costs and speed up market entry for generics.45
Impact — Environmental protections could be undermined if market access is prioritized over ecological risk assessments.6
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Meeting with Tomislav Sokol (Member of the European Parliament, Shadow rapporteur) and DSW (Deutsche Stiftung Weltbevoelkerung)

8 Nov 2023 · Pharmaceutical legislation

Meeting with Dolors Montserrat (Member of the European Parliament)

23 Oct 2023 · Revision of the pharmaceutical legislation

Meeting with Nathalie Colin-Oesterlé (Member of the European Parliament)

20 Oct 2023 · Pharmaceutical review

Meeting with Kateřina Konečná (Member of the European Parliament, Shadow rapporteur)

28 Sept 2023 · Pharmaceutical package legislation

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

5 Jul 2023 · Pharmaceutical legislation

Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur) and MEDICINES FOR EUROPE and

7 Jun 2023 · Medicines

Teva Pharmaceuticals warns packaging rules could impact medicine supply

24 Apr 2023
Topic — The European Commission is reviewing packaging requirements to increase recycling and reduce waste.
Message — Teva warns that changing primary packaging requires three-year stability studies and approvals. They argue medical devices should be excluded to ensure patient safety and supply. They also propose replacing paper leaflets with digital versions to cut waste.123
Why — Exemptions would prevent supply delays and avoid expensive, multi-year product stability testing.4
Impact — Environmental groups lose potential waste reductions if medical packaging remains excluded from rules.5
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Teva urges scientific rigor in EU water pollutant revisions

14 Mar 2023
Topic — The EU is updating lists of chemical pollutants in surface and groundwaters.
Message — Teva requests that pollutant list revisions remain a co-decision procedure involving the Parliament and Council. They also argue for individual substance standards rather than blanket limits for pharmaceutical compounds.12
Why — Individual substance standards help Teva avoid blanket market restrictions on its pharmaceutical portfolio.3
Impact — Patients may lose access to essential medicines if volume reductions meet environmental limits.4
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Teva warns wastewater rules threaten European medicine security

14 Mar 2023
Topic — The EU is revising rules to better protect water from micropollutants.
Message — Teva rejects the current proposal for extended producer responsibility (EPR) requirements on the pharmaceutical sector. They argue the commission lacks robust evidence and underestimates the financial impact on medicine supplies.123
Why — Avoiding these costs would prevent market withdrawals of low-margin generic medicines.4
Impact — Environmental health and public budgets suffer if pharmaceutical companies avoid treatment costs.5
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Response to Revision of EMA fees

7 Feb 2023

At Teva pharmaceuticals, our mission is to improve the lives of patients across the globe. In Europe, Teva is a strategic partner of healthcare systems, producing 96% of its European generic, biosimilar and innovative portfolio in plants across 15 European countries (53% of our APIs are manufactured in-house, 40% of which are in Europe), and 2020 saving healthcare systems more than 8.4. billion EUR across 9 European countries in which we support more than 105,000 jobs. Teva welcomes the opportunity to provide feedback for a revised regulation on EMA fees. Teva supports a cost-based EMA fee system that is reflecting the time spent on the assessment. However, the structure of the fees needs to be made clear, breaking down the costs of what exactly is funded. This is especially needed in case of flat fees like the annual ones. The mechanism of controlling those costs and the allocation of fees shall be also put in place to regularly assess the fairness of the system. We welcome the inclusion of Type IA and IB variation fees into the annual fees. It offers a major simplification of payments. It is also reducing the administrative burden, both for the regulators and the industry. Although the reduction of the fees for scientific advice will encourage companies to engage in dialogue with the authorities earlier, supporting product scientific development, we would like to emphasise that the reduction of fees should neither impact the quality nor limit the capacity to perform this advice. For some time now, the industry has been experiencing delays in access to scientific advice as well as a reduction in the extent of the answers to their questions. We would also like to see a clarification on whether the follow-up scientific advice is free of charge, or if it will be considered as a new scientific advice charged as an initial one. We are very concerned by the overly, unjustified high increase in the annual pharmacovigilance fees. The reason for such a large increase is not clear, therefore a clear breakdown of the costs should be provided, with a justification of what exactly is going to be additionally funded by this annual fee. This proposed increase will disproportionately impact generic medicines producers, due to the calculation of payments based on the so-called 'chargeable unit' related to the number of marketing authorisations, challenging the market sustainability of some generics, and Europes strategic autonomy for some essential medicines. While Teva agrees that the assessment of an application for a biosimilar medicine is more complex than the assessment of an application for a generic medicine due to comparative clinical trials, it should be mentioned that the current trend is moving towards having a more efficient data package that would not require the same resources currently spent by the EMA. Indeed, the time to review a biosimilar application may now be shorter compared to the assessment performed in the past and as such the significant increase in fees will soon not be justified and cost based. Therefore, we do not believe that the current fee proposal for biosimilars is neither aligned with the principle supporting this legislation, nor fit for purpose to support their future development. In conclusion, we would like to underline that for generics and biosimilar medicines, unjustified, non-proportionate, and non-cost base regulatory fees have an impact on patient access to essential medicines, due to their negative effect on maintaining some older, less profitable products on the market. To support the ambition to secure supply in Europe, it is crucial that the forthcoming discussions on the EMA fees legislation as proposed by the European Commission address these identified gaps to avoid the withdrawal of older, but essential medicines for the European patients.
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Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur) and Ipsen Pharma

14 Jul 2022 · Medicines

Response to Single Market Emergency Instrument (SMEI)

11 May 2022

Teva is a strategic partner of EU healthcare systems, producing 96% of its European generic, biosimilar and innovative portfolio in plants across 15 European countries. In addition, 53% of our APIs are manufactured in house, 40% of which is in Europe, and in 2020 Teva saved healthcare systems more than 8.4. billion EUR across 9 European countries in which we support more than 105,000 jobs. Learning from the COVID-19 crisis, Teva welcomes the proposal for Single Market Emergency Instrument, which should make sure that the European medicines supply chain will be resilient and prepared for any future crisis. We have to stress the need for a proper alignment between any potential legislation and other EU crisis response initiatives and mechanisms concerning pharmaceuticals, notably the setup of the Health Emergency and Response Authority and the EMA extended mandate for handling medicine shortages in crisis situations. Regarding the crisis preparedness pillar, we need to highlight that every crisis may affect different part of the supply chain, therefore predicting the effects is very complex. The pharmaceutical industry needs overall strengthening to be able to react to the emerging crisis. Furthermore, uncoordinated national stockpiling of medicines, would jeopardise the integrity of Single Market by shifting the strain on the medicines supply chain from one country to another or threatening products’ economic sustainability, which would lead to lowered supply chain resilience. Any stockpiling for crisis situations should be part of the EU civil society protection mechanism, paid for via other mechanisms than joint procurement, which has proven to be ineffective during COVID19 for medicines purchasing. Any stockpiling should also be coordinated and managed at EU level, to facilitate geographical allocation where patients’ needs are. Moreover, a single European list of the most critical medicines and an interoperable, digitalised pan-European shortages reporting system, alongside a clear two-way dialogue between industry and authorities will facilitate companies’ ability to address supply risks and response to crisis situations. On the crisis response pillar, we see the need to reflect on the current data-gathering systems. At the moment, medicines manufacturers are already providing massive amount of data across various systems both on European and Member States level. Europe is currently lacking harmonisation over the systems and a robust tool that would be able to analyse the data. Any further demands for data from the manufacturers should be clearly explained with the reason for collecting the data and presenting the way the data will be analysed and used. Additionally, the available data related to shortages should be shared with the industry in a two way dialogue with the concerned regulators to enable pro-active mitigation of potential market shortages. A two way dialogue is absolutely critical to avoid as much as possible any supply disruption during a crisis and in order to give both the industry and regulators the predictability needed to take timely actions. Last but not least, we are also welcoming any support that would facilitate the implementation of the warm manufacturing concept for essential medicines to enable fast ramp-up of production capacity to face sudden increase of high demand. In general, Teva encourages systemic reforms and concrete support to secure essential medicines manufacturing investments in Europe aligned with the EU open strategic autonomy prerogative. At Teva we commissioned a survey (enclosed) in 2021 of 3000 patients living with chronic diseases across Europe to understand their expectations regarding the pharmaceuticals manufacturing. 84% indicated they want their governments to support manufacturing investments to ensure Europe can produce critical medicines. It is time now to learn lessons from the pandemic and deliver on patients expectations.
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Teva Pharmaceuticals urges EU to prioritize voluntary licensing agreements

29 Apr 2022
Topic — The EU is reviewing rules for compulsory patent licensing during crisis situations.
Message — Teva believes voluntary cooperation is the most effective way to expand medicine production. They argue compulsory licensing should remain an exceptional last resort used only after voluntary options fail.12
Why — Maintaining voluntary models protects the company's control over its patent portfolio and pricing.3
Impact — Healthcare systems and patients may face higher costs or slower access during crises.4
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Meeting with Margaritis Schinas (Vice-President) and

16 Jun 2021 · Supply chains for medicines

Response to Evaluation and revision of the general pharmaceutical legislation

27 Apr 2021

Teva is a strategic partner of EU healthcare systems, producing 93% of its European generic, biosimilar and innovative portfolio in plants across 15 European countries (53% of our APIs are manufactured in house, 40% of which is in Europe), and saving healthcare systems more than €7.5B across 12 countries in which we support more than 112,600 jobs. The European Commission’s plan to revise the EU’s general legislation on medicines for human use should integrate COVID-19 lessons learned, and industry’s proposals to address long-lasting issues impeding the development of a resilient, sustainable, competitive and vibrant pharmaceutical sector, proven to be strategic for Europe’s Health, to: 1) Foster innovation, including in areas of unmet medical need: Although Teva acknowledges ad-hoc changes (e.g. extending and harmonising the Bolar exemption to API supply, banning patent linkage) are needed to ensure smooth generic and biosimilar competition after expiry of exclusivity, we do not support a broad revision of existing incentives. This may jeopardize the current balance between in- and off-patent medicines and hinder Europe’s ability to foster innovation and access. Europe must support all forms of innovation, including in the off-patent sector (value added medicines), as proposed below. 2) Adapt to new scientific and technological developments: Europe lacks an adequate regulatory framework to foster the development of drug-device combinations, in particular of digital medicines. For value added medicines, we recommend the establishment of a new and simplified regulatory pathway, enabling clarity early in the development and recognising value added medicines as a category of innovation with appropriate incentives. By doing so, Europe can further support its digital transformation, to further address patients’ unmet needs. 3) Ensure access to affordable medicines: Cost-based economic models should be avoided and value-based models should become the norm to avoid a race to the bottom, which may impact access to both in- and off-patent medicines. Pragmatic evidence, such as RWD/RWE, should be used to recognise the value of all types of innovation. Economic and regulatory barriers limiting generic and biosimilar uptake should be addressed. Reforming procurement models should be prioritised to introduce systematically multi-winner, multi-criteria models, ensuring supply diversity, resilience and sustainability, hence improving security of supply. 4) Improve security of supply: It is essential to secure manufacturing resilience and robust supply chains by reflecting on the root causes weakening industry’s ability to supply and on COVID-19 lessons learned. A single European list of the most critical medicines and an interoperable, digitalised pan-European shortages Reporting System, alongside a clear two-way dialogue between industry and authorities will facilitate companies’ ability to address supply risks. Any additional regulatory requirements, obligation to supply, penalties or ill-conceived stockpiling, risk fragmenting the single market, jeopardising its integrity by shifting shortages from one country to another or threatening products’ economic sustainability, which may lead to further shortages. 5) Reduce red tape: There is need for a more cost effective and flexible regulatory system which supports Europe’s transformative digital and green priorities, while preserving access to medicines and industry economic sustainability. The variations regulation needs to be optimised to reduce the cost to perform basic regulatory administrative, while providing the same high regulatory standards. Additionally, timely implementation of ePI (replacing paper leaflet) should be a priority, as well as streamlining API assessment, and ensuring better GMP/Manufacturing management and resources. On environment, scientific based approach and self-regulated initiatives inspired for example by the AMR alliance should be favoured.
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Response to Proposal for a Regulation on a Union framework addressing public health emergencies (EMA)

2 Feb 2021

As a leading global pharmaceutical company, Teva provides medicines to more than 200 million patients around the world every day. Ensuring patients get access to their treatments when they need them is at the heart of our mission. Therefore, addressing and preventing shortages and guaranteeing security of supply is a priority for Teva, including during health emergencies situations. Overall Teva supports the draft proposal to enlarge responsibilities of EMA on monitoring, reporting and notification of shortages, as well as enhanced dialogue and coordination during health crisis. The draft misses the acknowledgment of the role of the industry and pharmaceuticals supply chain actors during the covid19 crisis which demonstrated strong resilience through continued manufacturing, avoiding any major supply disruption for patients impacted by the virus or not and despite a challenging international context. Teva believes that in order to better manage a crisis, it is crucial that any decisions are based on a robust information system in place and functional also under normal circumstances. Teva is convinced that an harmonised pan-European interoperable and digitalized shortages reporting and notification system should be at the center of any future crisis management. Such system should underpin a two-way communication between industry and authorities: a prerequisite to manage medicines shortage. The combination of such information and communication systems would provide the transparency needed to take actions to prevent and mitigate cross border shortages. It would enable coordination and solidarity, increase efficiency, better visibility and predictability during crisis situations, speed-up the decision-making process, while avoiding duplications of efforts, red tapes and miss communication. In this respect, the proposal lacks ambition to create an interoperable, harmonized and digitalized platform and an efficient two way communication with industry and all concerned stakeholders. As drafted, the proposal creates several layers of reporting, from industry and authorities towards EMA. Through a pan-European harmonized and interoperable digital system, the reporting would be based on collecting data on the national level, where the Marketing Authorization Holders (MAHs) would report into a shortage reporting database. With data collected in digital and harmonised fields, and based on a common definition, the EMA could receive aggregated data from national databases to monitor any potential cross-border shortages. The electronic form and data submitted should be compliant with ISO IDMP standards for the identification of human medicines and be based on a harmonized data collection model with interoperability with SPOR data. Teva believes that such harmonised interoperable and digitalized reporting and notification system should be functional and operational in all circumstances, as a prerequisite for any health crisis management. Additionally, we believe that in the different fora and structures proposed in the draft legislation, a more consistent involvement of industry and supply chain actors should be established to enable an efficient dialogue and two way communication between authorities, industry and supply chain actors, for example during the elaboration of the list of critical medicines. As shown from the experience of the covid19 crisis, one of the key benefits of such two way communication, is to start early discussions about expected potential drug shortages in the market by way of sharing expected supply constraints which authorities become aware of via the notification process, while triggering regulatory flexibilities to enable supply from another market by alternative Marketing Authorisation Holders. Finally, the implementation of regulatory flexibilities by EMA and national regulatory authorities should be kept to facilitate fast move of medicines across borders to prevent or mitigate any supply disruptions.
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Response to Proposal for a Regulation on serious cross-border threats to health

2 Feb 2021

Teva provides medicines to more than 200 million patients around the world every day. Our mission is to improve the lives of patients across the globe. As proven during the COVID-19, a vibrant dialogue between competent authorities, policy makers and industry is needed to achieve our common objectives to secure sustainable and equitable access to medicines for patients. The spirit of the proposal is positive to ensure that there is a pan-European approach and coordination in the context of cross border threats to health. However, the current legislative proposal should further consider and recognize the dialogue and involvement of industry and other supply chain stakeholders in all forthcoming mechanisms to secure supply. A regular, open and transparent dialogue among regulators and all concerned key stakeholders has proven to be critical to secure supply of health countermeasures as demonstrated by the industry ICU Medicines Project. The very much needed two-way communication between policy makers, regulators and industry needs to be strengthened to have a more efficient management of crisis situations. Industry and supply chain actors need to be informed and involved early on, starting from the elaboration of the list of critical medicines needed, to be able to react promptly and avoid supply disruptions for patients. The proposal lays down rules on Joint procurement to ensure equitable access of medical countermeasures across the EU in the context of cross border threats to health. Although Teva agrees with the objectives of the proposal, we remain extremely concerned on the use of such mechanism, as it has shown to be neither practical nor predictable enough to achieve the above mentioned objective. Therefore Teva does not encourage the use of Joint Procurement for future cross border health threats, and believes that some principles and conditions shall be fulfilled, would such mechanism be deployed in the future. First, the primary purpose of joint procurement should be to guarantee stability in an unpredictable environment in the context of a cross-border health crisis only. This should be the underpinning condition to trigger joint procurement. In other circumstances, national procurement processes should rather be applied and regular market dynamics on demand/supply considered instead. Joint procurement must be carried in a transparent, timely and effective way to prevent further market disruption. To this end, it is crucial to define clear steps since the beginning of the procedure and ensure transparency in terms of process, scope, tender specifications, timelines and formalities. A preliminary consultation phase involving participating industry/manufacturers would be necessary to ensure such objective. In addition, being the scope for cross border threats for health only, it means that production could be necessary with short notice due to health crisis situations, hence it is important that joint procurement lead times are aligned with manufacturers lead times. Certain flexibilities to supply markets faster should also be allowed, for example by accepting each other Marketing Authorizations in case of emergencies. Joint procurement also implies shared responsibilities and a fair approach with rights and obligations for all parties involved, relevant authorities and manufacturers, for example by ensuring clear volume/purchase commitments. In addition, to prevent distortion of the market competition, and avoid duplications of processes, it is crucial that Member States do not source the same medicines by parallel means. Last but not least, specific provisions related to the awarding parameters should be defined, notably looking at criteria beyond the cost/price. If pursued, joint procurement for cross border threats to health should be shaped based on a clear, structured and sustainable system, while putting practicality, predictability and security of supply at the heart of it.
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Response to Revision of the EU legislation on medicines for children and rare diseases

6 Jan 2021

Teva is a strategic partner of European healthcare systems. Teva is committed to researching and developing new therapeutic options for unmet medical needs and improving affordable and equitable access to quality medicines. As a hybrid company and the European leading provider of generic medicines, Teva is uniquely positioned to help more people access medicines and, therefore, wishes to provide the following contribution to the Inception Impact Assessment on the Orphan and Paediatric Regulations (IIA). Teva believes that generic, biosimilar and innovative medicines are part of a single ecosystem aiming at answering patients’ unmet needs, while ensuring access to innovative, resilient and sustainable healthcare systems. It is through the innovation brought on by specialty medicines that generics and biosimilars can improve access and sustainability, thus, supporting the financial flexibility healthcare systems require to afford new therapeutic options for previously unmet medical needs. As such, all health policy actions should recognise and respect the entire lifecycle of medicines and take into account both on- and off-patent products. A stable and healthy environment thus requires a predictable incentives framework. That is why Teva is alarmed over the options foreseen in the IIA, which seem to risk destabilising the whole ecosystem rather than looking at how it can be improved. Of particular concern is the proposed modulation of market exclusivity under the Orphan Regulation. We do not support this, as it would introduce significant uncertainty for all actors. Lack of predictability does not favour R&D investments in any way and leads to legal uncertainty, which could aggravate access to off-patent medicines. In fact, the Dolon report (attached) has shown that legislative changes could reduce the number of products approved alongside an Orphan designation, hence playing against the public health objective of providing patients with rare diseases the medicines they need. Still on the matter of incentives, Teva would also like to raise the Commission’s attention to the fact that the “transferable voucher” proposed as a possible new incentive, could also bring additional uncertainty for off-patent medicines, hence, creating additional obstacles to access to medicines. Teva is also concerned by the fact that the Commission’s approach fails to address existing loopholes preventing early access to generics. The interpretation of “similarity” must be clarified so that orphan exclusivity does not affect generics of “similar medicinal products”. This requires the Commission to consider the entire pharmaceutical sector, not only the innovative side, as the IIA seems to do, therefore failing to enhance existing dynamics to stimulate competition, which could bring the sustainability needed while stimulating innovation. Furthermore, it is important to recognize that generic and biosimilar companies face similar complexity and challenges as innovator companies when developing and supplying products for Orphan indications, as such, they should benefit from tailored regulatory incentives to support their development and stimulate fair competition. Additionally, as an alternative to any legislative approach focusing only on incentives, Teva believes access issues regarding orphan and paediatric medicines can also be targeted by defining new pricing models for innovative OMPs and stimulating market entry of generics and biosimilars. Finally, to best assess the changes needed while avoiding any effects on the functioning of the pharmaceutical ecosystem that may have a detrimental impact on patients, Teva also calls for a High Level Forum. Thus establishing a structured dialogue with relevant stakeholders to identify and agree on alternatives to ensure the right balance between the need to reconcile public health considerations, the sustainability of healthcare systems, and ensuring the resilience and competitiveness of the European industry
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Meeting with Thierry Breton (Commissioner) and

20 Oct 2020 · Production capacity of generic medicines in the EU

Meeting with Frédérique Ries (Member of the European Parliament)

6 Feb 2020 · Pénurie de médicaments

Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis)

28 Mar 2019 · Developments in the field of digital health