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PHARMIG - Verband der pharmazeutischen Industrie Österreichs

PHARMIG

PHARMIG is the voluntary interest group representing the pharmaceutical industry in Austria.

Lobbying Activity

Meeting with Günther Sidl (Member of the European Parliament)

13 Nov 2025 · General Exchange of Views

Meeting with Angelika Winzig (Member of the European Parliament, Rapporteur for opinion) and Boehringer Ingelheim

5 Nov 2025 · Meeting with representatives of Boehringer Ingelheim & Pharmig

Meeting with Sophia Kircher (Member of the European Parliament) and Boehringer Ingelheim

4 Nov 2025 · Chemicals Omnibus, EU-US relations

Meeting with Michael Hager (Cabinet of Commissioner Valdis Dombrovskis)

13 Oct 2025 · Competitiveness of the pharmaceutical industry; environmental & industrial compliance omnibus.

Meeting with Angelika Winzig (Member of the European Parliament, Rapporteur for opinion)

11 Sept 2025 · Meeting with representatives of Pharmig

Austrian pharma industry urges robust biotech investment and IP framework

11 Jun 2025
Topic — The Biotech Act aims to create an environment for accelerating biotechnology commercialization.
Message — PHARMIG advocates for a robust IP framework to provide effective R&D incentives. They seek simplified cross-border clinical trials and faster regulatory procedures for innovations.123
Why — These measures would reduce financial risks and accelerate commercialization of pharmaceutical products.45
Impact — Public payers may see increased spending as health budgets are reclassified as investments.6
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Meeting with Alexander Winterstein (Cabinet of Commissioner Magnus Brunner)

11 Jun 2025 · Competitiveness of the pharmaceutical industry in Europe, and in particular in Austria

Meeting with Alexander Bernhuber (Member of the European Parliament)

14 May 2025 · Kommunale Abwasserrichtlinie

PHARMIG urges strong IP protection in EU life sciences strategy

17 Apr 2025
Topic — A new European strategy to boost competitiveness and innovation in life sciences.
Message — The organization calls for a competitive framework for intellectual property and expanded research support measures. They request simplified cross-border clinical trials and targeted funding to reduce dependence on non-European production. Finally, they seek faster regulatory procedures and better secondary use of health data.123
Why — These proposals would lower manufacturing expenses and secure long-term profits through IP incentives.45
Impact — Environmental groups may see ecological standards weakened in favor of industrial competitiveness.6
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Meeting with Hubert Gambs (Deputy Director-General Internal Market, Industry, Entrepreneurship and SMEs)

9 Apr 2025 · PHARMIG requested the meeting to address issues concerning the pharmaceutical industry and its competitiveness.

PHARMIG urges mandatory manufacturer involvement in EU health assessments

29 Mar 2024
Topic — New EU framework for the joint clinical assessment of medicinal products.
Message — PHARMIG requests mandatory involvement of manufacturers throughout the assessment process to ensure realistic scoping. They propose extending the dossier submission deadline to 135 days to handle extensive data requirements. The association also demands mandatory consultation of patients and medical experts.123
Why — This would prevent unworkable deadlines and reduce the risk of redundant national data requests.45
Impact — Patients could face delayed access to innovative therapies due to bureaucratic publication timelines.6
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Meeting with Claudia Gamon (Member of the European Parliament)

20 Feb 2024 · Pharmapaket

Meeting with Angelika Winzig (Member of the European Parliament)

7 Dec 2023 · Austausch zu Pharma-Legislativpaket

PHARMIG warns EU pharma reform threatens medical innovation

8 Nov 2023
Topic — Consultation regarding the revision of the European Union's general pharmaceutical legal framework.
Message — PHARMIG demands maintaining long data protection periods and decoupling incentives from mandatory market launches. They call for a broader definition of medical needs to foster research.12
Why — Preserving existing protection periods would safeguard investments and reduce risks for pharmaceutical companies.3
Impact — Generic manufacturers lose predictability and face delayed opportunities to offer more affordable alternatives.4
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Austrian Drug Industry Opposes Cuts to Research Data Protections

8 Nov 2023
Topic — The EU is revising its general pharmaceutical legislation to improve medicine access.
Message — PHARMIG requests maintaining current data protections and removing requirements to launch in all member states. They advocate for an inclusive definition of medical needs to support research.123
Why — This protects high profit margins by delaying competition from cheaper, non-branded generic medicine manufacturers.4
Impact — Environmental organizations lose if ecological risks cannot be used as grounds for refusing medicine approvals.5
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Meeting with Angelika Winzig (Member of the European Parliament)

25 Oct 2023 · pharma legislation

Meeting with Tiemo Wölken (Member of the European Parliament, Rapporteur) and European Federation of Pharmaceutical Industries and Associations and

7 Sept 2023 · Revision of the Pharmaceutical Legislation (staff level)

Meeting with Angelika Winzig (Member of the European Parliament)

7 Sept 2023 · EU Pharma Legislation

Meeting with Angelika Winzig (Member of the European Parliament)

20 Jul 2023 · Austausch zum Medizinprodukte Paket

Response to Vaccine-Preventable Cancers

31 Jan 2023

We herewith take the opportunity to provide our feedback for proposal for recommendation. Please find below joint feedback by PHARMIG & ÖVIH on cancer prevention: HPV (humane papilloma virus) vaccination offers a unique opportunity to protect children and adolescents from cancers caused by HPV. With such a preventive option in hand, it is an indispensable task of public health systems to ensure the highest possible vaccination coverage in order to prevent many cancers and other HPV-associated diseases. Gender-neutral vaccination is particularly relevant here; girls and boys should receive the HPV vaccination. Not only to stop the spread of the viruses, furthermore HPV can also cause cancers in boys/men. In Austria we already have a recommendation for the gender-neutral HPV-vaccination for years. The WHO has declared a 90% HPV-vaccination coverage rate for girls by 2030 to achieve the elimination of HPV-associated cancers. Austria also joined this target and therefore extended the free HPV vaccination until the age of 21 (as of February 1, 2023) which is a very good activity introduced by BMSGPK (MoH) recently together with all federal states and the social insurance. The Austrian vaccination recommendation has confirmed that the HPV vaccination should be given as early as possible - in Austria at the age of 9. This is the only way to ensure early protection against HPV-associated cancers. A requirement for increasing the vaccination coverage rate is to ensure a low-threshold access to HPV vaccination. In Austria, it is the task of the federal states to create this access. At the moment, this is happening in very different ways and overall not satisfying. The goal must be that every child throughout Austria receives an active vaccination offering at school. We encourage an Austrian wide program by BMSGPK conducted by doctors at schools and additionally in the extramural sector or at public vaccination centres. The free child vaccination concept in Austria also includes the vaccination against Hepatitis B. Increasing vaccination coverage can be achieved by providing a low-threshold access to this vaccination too.
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Meeting with Günther Sidl (Member of the European Parliament) and Wirtschaftskammer Österreich and Boehringer Ingelheim

20 Oct 2022 · General Exchange of Views

Meeting with Johannes Hahn (Commissioner) and

28 Jul 2022 · Current economic and geopolitical challenges. European strategic autonomy. Consequences of Covid-19 for European health policy.

Austrian Pharma Warns EU Against Weakening Intellectual Property Rights

29 Apr 2022
Topic — The Commission considers harmonizing compulsory patent licensing rules for EU-wide crisis situations.
Message — PHARMIG insists intellectual property is essential for innovation and risky investments. They recommend the Commission support voluntary cooperation rather than endangering it with compulsory licenses. If introduced, licenses must require strict crisis definitions and full patent holder involvement.1234
Why — Stricter licensing requirements help maintain high profit margins and market exclusivity.5
Impact — Public health authorities may struggle to bypass patents quickly during emergencies.67
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Austrian pharma industry urges centralized EU protection certificates system

5 Apr 2022
Topic — Proposal to create unitary Supplementary Protection Certificates to reduce fragmentation in pharmaceutical patents.
Message — PHARMIG strongly supports a centralized system and a new unitary certificate for patents with unitary effect. They propose a dual system with a single granting mechanism for both unitary and national certificates. This should be managed by a central virtual authority composed of national experts.1234
Why — The organization would benefit from simpler administrative procedures and reduced duplication of costs and efforts.5
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Response to Cancer Screening Recommendation

21 Feb 2022

Im Folgenden nimmt die PHARMIG - Verband der pharmazeutischen Industrie Österreichs - Bezug auf die „Aufforderung zur Stellungnahme der Europäischen Kommission zur Initiative Empfehlung zur Krebsfrüherkennung“ (GD SANTE - Europas Plan gegen den Krebs – Taskforce): Ziel von Krebsvorsorge ist es gesundheitliche Risikofaktoren zu vermeiden und somit das Entstehen von Erkrankungen zu verhindern, sowie etwaige Erkrankungen frühzeitig zu erkennen, um rechtzeitig Behandlungsmaßnahmen zu setzen und bessere Heilungschancen zu erreichen (1). Vorsorgeuntersuchungen haben auch einen wesentlichen Anteil an der gestiegenen Lebenserwartung in Österreich. So ist die Lebenserwartung in den letzten Jahrzehnten deutlich angestiegen und liegt aktuell bei Männern bei 79,5 (67 Jahre in 1974) und bei Frauen bei 84,2 Jahren (75 Jahre in 1974) (2). In Österreich erkranken jährlich etwa 42.000 Menschen an Krebs, Männer sind etwas häufiger betroffen als Frauen. Für beide Geschlechter stellen bösartige Tumorerkrankungen, nach den Herz-Kreislauferkrankungen, die zweithäufigste Todesursache dar (3). Ein Schwerpunkt der Vorsorgeuntersuchung liegt auf Krebserkrankungen. Neben der Früherkennung von Gebärmutterhalskrebs (PAP Abstrich ab Alter von 18 Jahren), wird die Früherkennung von Brustkrebs (für Frauen im Alter von 45 bis 69 Jahren) und Darmkrebs (im Alter von 50 Jahren) empfohlen. Relevant für die Teilnahme an Vorsorgeprogrammen ist das organisierte Einladungsmanagement (4). Ebenso wichtig ist die Erarbeitung und fachliche Begleitung von bundesweit einheitlichen Qualitätsstandards unter Mitwirkung von entsprechenden Expertinnen und Experten. Die Berücksichtigung internationaler Standards und Guidelines muss auch im Rahmen der laufenden Evaluierung sichergestellt sein. Die Vorgehensweise unterstreicht die zentrale Rolle von Vorsorgeuntersuchungen in der Krebsversorgung (5). Auch der bundesweit gleiche niederschwellige Zugang zur Leistungserbringung stellt eine wesentliche Voraussetzung dar.   PHARMIG spricht sich auch für die Erweiterung der Vorsorgeuntersuchungen auf weitere Krebsarten wie Prostata-, Lungen- und Magenkrebs aus. Die Prostata-Früherkennung (PSA-Untersuchung ab 50 Jahren) kann auf Wunsch in Anspruch genommen werden. Rezente wissenschaftliche Erkenntnisse zeigen die Bedeutung der Früherkennung im Bereich Lungenkrebs (6). Hautkrebs – eine der häufigsten Krebsarten lt. Statistik Österreich – wäre vermutlich in vielen Fällen mit entsprechenden Vorsorge- und Aufklärungsmaßnahmen vermeidbar. Intensive Forschung in der personalisierten Medizin führt dazu, dass laufend innovative Diagnoselösungen entwickelt werden. Daher sollten die zum Einsatz kommenden Methoden der Diagnostik laufend evaluiert und aktualisiert werden (z.B. Genom-Analysen) (7). Prädiktiv-, Frühdiagnostik und genetische Prädispositionen werden immer wichtiger, ebenso wie frühzeitiges und ausführliches Testen. Die Weiterentwicklung von praktikablen Testverfahren und -Abläufen sowie die Investition in die Aus- und Weiterbildung der beratenden und therapieentscheidenden Experten: innen sollte auch berücksichtigt werden. Sehr gerne stehen wir für Rückfragen zur Verfügung. (1) OEGHO Österreichischer Krebsreport 2021 (2) Statistik Austria 2021 (3) Statistik Austria 2022 (4) Evaluationsbericht zum Brustkrebs-Früherkennungsprogramm, Evaluationsbericht des BMSGPK 2021 (5) EU Kommission „State of Health in the EU Austria Country Health Profile 2021“ (6) NELSON Studie, N Engl J Med 2020 (7) Unlocking the potential of precision medicine in Europe, EFPIA 2021
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PHARMIG warns against linking research incentives to market access

27 Apr 2021
Topic — The European Commission is revising the laws governing pharmaceutical products and innovation.
Message — PHARMIG calls for an agile, centralized framework for approvals and faster innovation pathways. They oppose linking research incentives to market access because access depends on national policies.12
Why — Reduced administrative requirements and digital labeling would lower company compliance costs.34
Impact — Patients risk continued delays if national governments do not remove market access barriers.5
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Response to Revision of the EU legislation on medicines for children and rare diseases

23 Dec 2020

The creation of a system of incentives within these Regulations have been identified as the essential and target-oriented measures to increase research and development for rare diseases and children in the EU. And indeed, the evaluation of the Regulations found that both Regulations fostered the development and availability of medicines in these areas. The Paediatric and the OMP Regulation are best practice examples to stimulate R&D in these neglected areas. The OMP Regulation has incentivised the pharmaceutical sector to deliver treatments for up to 6,3 million patients (by 2018). Most of the options presented in the IIA are focusing to reduce important incentives, which will have a negative impact for many patients, or are constituted so vaguely that the resulting consequences are difficult to assess. On the contrary the introduction of new incentives building on and complementing existing incentives is of paramount importance to foster R&D in these areas. We strongly agree that the main goal of the revision of the OMP Regulation is to address (high) unmet needs. Since rare diseases can no longer be viewed as a homogeneous group for which no treatments are available, more differentiated tools besides dedicated research funding and accelerated regulatory pathways may be needed to foster direct investment to specific areas. In order to define unmet medical need a multi-stakeholder involvement is needed to overcome the narrow setting of conditional marketing authorization and include scientific and societal evaluation. Decreasing rewards and incentives to focus only on the very rare diseases where no treatment exists or on first in class innovation would not increase R&D into these areas of needs but rather risk undermining Europe’s attractiveness as a region for innovation. Limiting the designation criteria to less prevalent rare diseases risks leaving out significant numbers of pathologies and patients. The root causes of access issues to orphan medicines lie within national responsibilities, legislations and regulations. Furthermore, they are multifactorial and are not caused by decisions of single pharmaceutical companies. The responsibility for the organising, financing and providing health services lies within the competence of the Member States (MS) and not within the competence of the European Union. Therefore, access solutions have to be based on collaboration of national healthcare systems. Based on solidarity between MS, the implementation of a multi-stakeholder dialogue, including pharmaceutical industry, to address inequalities in access is highly recommended. In addition to that, an Orphan Access Monitoring Board could be established to secure equal access for patients in all MS. Facing the access problems across countries it is recommended to limit parallel trade of orphan drugs. Parallel trade jeopardizes stable and predictable supply which puts the provision of patients with orphan medicines at risk. This leads to market distortions and supply constraints in many MS. This issue should be addressed directly, rather than imposing obligations to put products on the market in all MS upon receipt of marketing authorization. In order to keep pace with scientific and technological developments, regulatory authorities need policies and processes that are in line with global regulatory and scientific developments. Scientific and procedural developments could be summarized in guidelines, e.g. on issues such as biomarker-defined conditions or class exemptions for paediatric development. Finally, we would like to point out that a weakening of the existing incentives for the development of OD and pediatric drugs would have a negative impact on Europe as a research and industrial site. We see this as a contradiction to the Industry Strategy of the EU Commission of March 2020, which advocates a competitive & innovative industry in Europe, as well as to the efforts to re-industrialize the life science sector in Europe.
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Austrian pharmaceutical industry demands stronger innovation and IP protections

7 Jul 2020
Topic — This consultation concerns the European Union strategy for medicine research and supply.
Message — PHARMIG requests a world-class intellectual property framework to attract investment for new treatments. They want faster drug approvals and a simplified regulatory network to match global competitors. The group also advocates for fair pricing and new payment models for medicines.123
Why — These changes would secure higher profit margins and lower the cost of compliance.4
Impact — National health budgets could face higher costs if drug price protections are extended.5
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