Dachverband der österreichischen Sozialversicherung
DVSV
Dachverband der österreichischen Sozialversicherung represents all social insurance providers in Austria.
Lobbying Activity
Meeting with Angela D'Elia (Head of Unit Economic and Financial Affairs)
20 Nov 2025 · Exchange views on current developments and challenges to a sustainable financing of solidarity-based social security systems in Europe and especially in Austria in view of the demographic change
Austrian Social Insurance warns against weakening medical device safety rules
6 Oct 2025
Message — The organization demands long-term clinical evidence instead of expected benefits to ensure patient safety. They oppose faster certification processes that rely on immature evidence and call for transparency regarding product withdrawals.123
Why — Strict evidence rules protect the healthcare system from funding treatments with unproven clinical benefits.4
Impact — Medical device manufacturers may face higher costs and delays due to stricter data requirements.5
Meeting with Jana Dabbelt (Cabinet of Commissioner Olivér Várhelyi)
25 Sept 2025 · future of healthcare financing within a solidarity-based social security system
Austrian Social Insurance demands patient safeguards in Biotech Act
11 Jun 2025
Message — They demand binding transparency for public subsidies and strict requirements for public return on investment. The organization warns against fast-track approvals based on immature evidence to protect patient safety. They also recommend early dialogues with health payers to align innovation with clinical needs.123
Why — This ensures public funding translates into affordable treatments, protecting the financial sustainability of health systems.4
Impact — Biotech companies would face stricter conditions for subsidies and potentially slower authorization processes.5
Austrian social insurers urge higher thresholds and simplified procurement rules
7 Mar 2025
Topic — Evaluation of EU directives governing public procurement and concession contract award procedures.
Message — The association requests raising the procurement threshold to 500,000 euros with automatic inflation adjustments. They also suggest removing the European Single Procurement Document to avoid delays. Finally, they want more freedom to choose procedures and negotiate contracts.123
Why — This would reduce excessive bureaucratic effort and ensure a more economical administrative process.4
Meeting with Evelyn Regner (Member of the European Parliament)
14 Feb 2024 · General Exchange of Views
Meeting with Evelyn Regner (Member of the European Parliament)
29 Jan 2024 · General Exchange of Views
Meeting with Günther Sidl (Member of the European Parliament)
31 May 2023 · Pharma Legislation/Arzneimittelgesetz
Meeting with Jens Geier (Member of the European Parliament)
17 May 2023 · Exchange on current pharma legislation (staff level)
Meeting with Joost Korte (Director-General Employment, Social Affairs and Inclusion)
16 Mar 2023 · Digitization of social security systems
Austrian Social Insurance urges opt-out rights for health data
28 Jul 2022
Austrian Social Insurance demands health data exemptions from Data Act
13 May 2022
Message — The organization calls for clear definitions and exemptions for institutions holding sensitive health data. They also request that technical protection measures for data become mandatory.12
Why — This would shield social security institutions from mandatory data sharing requirements for health records.3
Impact — Private firms and researchers lose guaranteed access to large public health datasets for innovation.4
Response to Cancer Screening Recommendation
22 Feb 2022
Cancer is one of the most pressing burdens to European citizens and comes at high personal as well as societal costs. Early diagnosis is a key factor to deliver adequate and successful treatment and help reducing the impact of cancer. As one of the key players in the Austrian health care sector, the Austrian Social Insurance fully supports the Europe’s Beating Cancer Plan and the update of the 2003 Council Recommendation on Cancer Screening included therein as one of the first deliverables. Especially, the intention to adapt the guidelines to the state of the art of scientific research/evidence is to be welcomed. It is necessary to take into account the numerous developments in this field over the last years based on the research methodology since this has probably been one of reason for countries to deviate increasingly from the recommendations of 2003.
Of course, the benefits of early screening programmes for e.g. cervical and colorectal cancers are widely proven and undisputable, whereas further investigations for breast, skin as well as prostate cancer eventually led to a rather controversial scientific debate. Key in this context is therefore the generation of sufficient evidence, which should be done by an adequate scientific research institution, prior to extending such structured large screening programmes to other cancer types.
When it comes to a EU-comparison of national screening programmes, differences in the implementation on national level should be closely taken into account, namely a conscious deviation from EU guidelines as to targeted patient population, scope and methodology, as well as their results/outcomes. This is the only way to make the most of a best practice exchange among EU Member States and promote mutual learning.
Another key principle in course of the update of the 2003 Council Recommendation should be the equitable/appropriate provision of high quality information in order to empower and support patients to take an informed and sound decision as to such screening programmes according to the universal right to self-determination and to information. This also includes a legal obligation for consultation and provision of good quality information with regards to medical treatments and screening programmes. Also there is growing evidence that decision aids may improve values-congruent choices. Therefore, the Austrian Social Insurance has already developed a brochure on adequate information concerning prostate cancer screening.
Eventually, the Austrian Social Insurance calls for a close consideration of the following principles when updating the EU guidelines:
• Highest degree of transparency
• Close involvement of all relevant stakeholders concerned by such screening programmes, especially when it comes to the patients themselves
• Sufficient evidence generation as to a possible extension of the screening programmes to other cancer types as well as a continuous update of evidence as proof of benefit
• Full accessibility and evaluation of data generated within these programmes (personalised feedback reports to the health service providers, pseudonymised for programme evaluation purposes, and anonymised for other purposes, such as scientific research)
• Clear distinction between the holistic approach of EU guidelines as a general framework and the content-related design of screening programmes based on scientific evidence as well as all necessary contractual and financial negotiations/agreements on a national level
Read full responseResponse to Improving the working conditions of platform workers
14 Feb 2022
The Austrian Social Insurance welcomes the European Commission’s proposal for a Directive on improving the working conditions for platform workers. As social security institutions, we stand for universal and modern social security protection for employees and self-employed alike. Without doubt, the COVID-19 pandemic has accelerated the introduction of digital business models and especially digital service platforms operating cross-border, creating new challenges for social security systems. We therefore acknowledge the intention to support a strengthened equal access to social protection following the European Pillar of Social Rights as well as the Council Recommendation on access to social protection. However, this has to be done carefully while fully respecting the national systems and the subsidiarity principle as laid down in Article 153 TFEU.
We point out that the Austrian legislator already implemented a formal system to distinguish employees from self-employed in 2017 (Sozialversicherungs-Zuordnungsgesetz, SV-ZG), also applicable on platform workers. This is an administrative procedure that can be appealed against in front of administrative courts. Core element of this procedure is a flexible system of specific criteria (e.g. personal and economic dependence, inclusion into the organisation, type of work, duty of good faith, etc.), which does not rely on a quantitative point of view but rather on a qualitative assessment of the individual situation. Thereby, the Austrian Social Insurance can guarantee a level playing field and transparent as well as reliable legal decisions. The proposal for the Directive requires Member States (MS) to set up such procedures in its Art. 3.
The Austrian Social Security stresses the following aspects, especially concerning Articles 4, 5, 11 and 19, which should be taken into account for the current proposal for a Directive:
We want to point out that MS have exclusive competence regarding the organisation of their social protection systems. According to Art. 153 TFEU the Union shall support and complement the activities of MS and may adopt minimum requirements in the field of working conditions by means of directives. However, this principle seems to be disregarded especially by Art. 4, which we therefore propose to amend.
With regard to Art. 4 p. 1, it should be considered to create a more flexible system which respects national legislation and is in line with already established administrative procedures. Art. 4 p. 2 should focus on a qualitative assessment of the individual situation rather than a solely quantitative (two out of five) approach, as too formal criteria might encourage the exploitation of loopholes and effectively undermine the goals of the Directive.
Additionally, it should be clarified that it is not a binary system but rather different national models of access to social security coverage are still applicable (for Austria for example § 4 Abs. 4 ASVG “freier Dienstvertrag” and § 4 ASVG in conjunction with § 5 Abs. 1 Z. 2, Abs. 2 ASVG “geringfügige Beschäftigung”).
Furthermore, individual requests to verify the employment status for both workers and platforms have to be guaranteed.
In addition, social security institutions should not be tasked with providing detailed case-related guidance, as the obligation in Article 4 p. 3 lit. b implies, but rather give general legal information, as a proper assessment can only be achieved within the limits of the administrative procedure (Art. 3).
For the duties of platforms in Art. 11, a further clarification on the (minimum) information required should be considered, so it’s comparable and interchangeable across the Union. Also, the duties mentioned in Art. 11 should not only apply to platforms which are employers, but to all digital platforms.
Regarding Art. 19 p. 2, it remains unclear, which information has to be shared with authorities competent for Reg. (EU) 2016/679, a further clarification is needed.
Read full responseResponse to European Digital Identity (EUid)
1 Sept 2021
The Austrian Social Insurance as one of the most active users of a digital identity warmly welcomes the Commission’s initiative to harmonise and fully implement a European Digital Identity (EUid). Being at the forefront of the provision of secure, trustworthy digital solutions and having the expertise needed for an efficient implementation, we fully support any steps to a safe cross-border use of a EUid in combination with a wallet containing relevant personal attributes. However, in order to not jeopardize already existing systems, we call for a close coordination with national Social Security Institutions as this initiative will have an extensive impact on all documents and certificates issued in this.
Essential for the implementation should be to ensure compliance with the existing provisions under the GDPR. Social Security Institutions vouch for a high level of privacy as well as data protection and should thus be closely involved in order to ensure broad acceptance of digital tools. In our view, it will be of utmost importance to ensure the protection of the respective data through specific technical provisions and thereby to avoid any shift to the individual when storing data/attributes. It should be duly clarified where as well as by whom such data shall be protected and clear rules for the requirements of the necessary safeguards should be established. We also call for more precise specifications as to the data carrier or platform used for the data transfer. Unfortunately, the proposal remains rather vague if this should happen via an active internet connection, a QR-code or NFC.
Another important factor will be securing an adequate level digital literacy among citizens when entrusted with a digital identity and the possibility to directly disclose personal sensitive data. Awareness raising campaigns and measures could be initiated at EU level to ensure the highest consistency among Member States.
As this initiative will furthermore imply fundamental changes in already existing national systems as well as established infrastructures, national service providers and administrative bodies need a reasonable timeframe in order to adjust. Adequate transition periods will eventually be key in order to secure compatibility and interoperability. Minimum requirements as to data formats should be defined jointly by Commission and national experts. Moreover, we call for an EU-level support concerning the respective implementation costs.
Concerning the technical implementation and readiness of mobile devices used, we call for the introduction of an obligation for manufacturers of mobile devices as well as providers of EUid solutions, wallets or apps to continuously provide their users with updates and maintain their operating systems. Equally important will be the introduction of the possibility to remotely delete or withdraw a digital identity and the respective wallet to avoid misuse or fraud. A clarification of the withdrawal mechanism as well as how to prevent unlawful access to locally stored data is eventually crucial.
Eventually, we call for a clarification of the specifics for the data storage in the context of the EUid and the respective EU Wallet (f.e. in Art 6a ff). A further specification of the relation between a central storage for authentication reasons and a local storage for citizens will be essential. In our view, the proposal remains rather vague concerning the obligation for competent authorities whether to provide these attributes in a purely digital form, hence guaranteeing access also via a local storage, or at the same time also in paper format, i.e. offline. However, agreeing with the need to introduce a requirement to accept digital identities and the associated attributes cross-border among Member States, any obligation on the format of digital certificates provided by Social Security Institutions should be avoided. An according mechanism should be included in the final text.
Read full responseResponse to Evaluation and revision of the general pharmaceutical legislation
27 Apr 2021
Since patients’ access to pharmaceuticals is increasingly jeopardised by a steady rise in pharmaceutical spending and pricing of medicinal products within the EU, the Austrian Social Insurance welcomes the evaluation and revision of the general pharmaceutical legislation. In recent years, the pharmaceutical sector has under the current legal framework evolved in a direction that has partly led to a misuse of the various incentive schemes. Lack of transparency, a concentration on therapeutic areas with high profit margins and in some cases excessive price demands are some of the results. Therefore, there is an urgent need to restore the balance between promoting innovation on one hand and ensuring affordability on the other hand.
Although the Austrian Social Insurance welcomes the development and the timely market launch of innovative drugs, esp. in areas with high unmet medical need (UMN), the respective incentives must not be exploited for disproportionate price demands and profits. First and foremost, a common, harmonised concept of (high) UMN consistently applied in the entire European legislative framework is crucial. We fully support the intention to explore novel alternative incentives throughout the entire development cycle as well as optimizing existing ones. Proposals for changes to the current system need to be discussed openly with all actors involved. Incentives should be tied to obligations for manufacturers, such as a compulsory market launch in EU27, transparency on R&D costs, adherence to joint scientific advice and the collection of post-launch data which also address information needs from HTA bodies and payers.
Faster marketing authorisations approvals, do not automatically guarantee faster access to medicinal products throughout the European Union. In this respect, joint scientific advice by both HTA agencies and EMA should reinforce informed downstream reimbursement decisions by payers, thus facilitating patient access. This has to be taken into account, esp. when connecting highly innovative drugs with EMA’s PRIME scheme and its subsequent accelerated assessment as well as in the context of increased use of real world data (RWD) through the Health Data Space foreseen later this year. RWD can provide important information, complementing clinical trial data, on the natural course of a disease, on patient characteristics in clinical practice and on therapeutic gaps. It can also serve as an external reference for determining comparative effectiveness. However, shifting evidence generation foremost on effectiveness to the post-marketing phase should be avoided whenever possible, since randomised controlled studies should continue to be the gold standard for marketing authorisation procedures. Exceptions should be based on sound reasoning and applied only in exceptional, well-described cases. Clear rules on data ownership including data transfer to third parties and for withdrawing consent, as well as methods and quality standards for collecting and analysing RWD need to be defined in European legislation as well. A framework for the conditions of use of RWD must be defined together with the national competent authorities, providing also for their exchange between Member States. The risk associated with high uncertainties concerning added value at time of marketing authorisation needs to be equally borne by payers and manufacturers.
Finally, the introduction of a mechanism to strengthen competition within the pharmaceutical market through enabling a faster and more streamlined approach on market entry of generics and biosimilars is another important element. Also the approval process for repurposed drugs should be facilitated provided that indication slicing and a possible “orphanisation” is prevented. In this context, it will be crucial to revise the intellectual property protection system in place and to find ways to increase competition within the pharmaceutical market without jeopardising innovation.
Read full responseResponse to Evaluation of patient rights in cross-border healthcare
11 Feb 2021
The Austrian Social Insurance welcomes the Commissions’ initiative to evaluate Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare. As the roadmap notes the evaluation will look into how the Directive interacts with Regulation (EC) No 883/2004 on the coordination of social security systems. From our view this is crucial as in practice the two regulatory systems are intensely interwoven and can only be fully assessed as a whole. Nevertheless, the Directive and the Regulation are based on different fundamental freedoms and thus different legal foundations. In the light of the above, we stress that the competences of the Member States with regard to social and health policy must be fully respected - the treaties must therefore be recognized (Art. 153 and Art. 168(7) TFEU). It is of utmost importance to make full use of the existing legal framework and to implement it before new legislative measures are introduced. Naturally patients should receive the best possible treatment. However, patients’ free choice of a treatment is closely interlinked with the financial stability and sustainability of national healthcare systems. Negative impacts concerning the independency as well as functioning of health systems have to be prevented by all means in order to fully respect Member States’ competences and to ensure their respective financial balance.
The Austrian Social Insurance has extensive experience regarding cross-border healthcare which we will gladly share to help shaping the ongoing evaluation. In our view, the current systems are efficiently implemented and cover patients’ needs. To our knowledge there is currently no administrative burden hindering patients to access cross-border healthcare as foreseen by European and national law. Although the co-existence of two different legal foundations might complicate the initial legal analysis, the competent national administrative bodies have done and do an excellent job in informing patients and handling the procedures securing the smooth functioning of the framework. Against this background, we would like to stress that no new administrative hurdles should be created that would make it difficult to implement the principles in the interests of EU citizens. National social security institutions and their European representatives must therefore be closely involved in any further steps. Especially, in the context of cross-border healthcare, there are several challenges as to implementation and enforcement of the existing legal provisions (e.g. electronic data exchange, cross-border cooperation, domestic regulations, etc.) that must be taken into account in the future decision-making process.
Read full responseResponse to Legislative framework for the governance of common European data spaces
5 Feb 2021
In light of the increasing digitalisation in the healthcare sector which was accelerated by the current COVID-19 pandemic, the Austrian Social Insurance warmly welcomes the European Commission’s proposal for introducing a European Data Governance fully in line with EU values and principles bringing significant benefits to EU citizens and companies. The current health crisis has shown the great importance of timely electronic cross-border exchange of data for the (effective) management of and recovery from such a pandemic but also as a preventive measure for future cross-border threats.
Key principle should be in this context ensuring compliance with the existing provisions under the GDPR in order to generate broad acceptance of digital tools among European citizens. In our view, the transparent and traceable exchange of notably synthetic data for the benefit of R&I is of utmost importance for the common good. We recommend implementing a centralised service point for generating synthetic data ensuring thereby the transformation of relevant data according to the intended use, improving the quality of the result and at the same time preventing an individual’s identification. Consequently, the Commission should implement measures to unleash the full potential of synthetic data. In this context, we support the effective use of strategic investment in digital programmes, as foreseen in the multiannual financial framework.
Social Security Institutions vouch for a high level of privacy and protection of data entrusted to them by their insured citizens. We therefore call for maintaining the possibility to give access to social security data exclusively to specific contract and cooperation partners under certain, well defined circumstances. As the proposal for a Regulation on European Data Governance would ban such exclusive agreements, we suggest introducing a clarification of the definition of “the provision of a service or a product in the general interest” which, in accordance with article 4(2) and 4(4) of the proposal would allow for granting an exclusive right to re-use data as an exemption.
Furthermore, we advocate adding a non-exhaustive list of permissible conditions according to article 5(1) of the proposal to be issued by public authorities/bodies for the re-use of publicly hold data. We would also welcome the possibility for public authorities/bodies to take into account the objective of this re-use of data in order to prevent any misuse. We consider the obligations in article 5(4) of the proposal don’t represent an exhaustive/definitive list of such conditions.
As to article 5(1) of the proposal, we call for specification of measures to efficiently make those conditions allowing the re-use of data publicly accessible. Such specification could in our view be also included in the recitals.
In the context of article 4(3) of the proposal, the Austrian Social Insurance also stresses the obligation of full application of European Union as well as national provisions for all procurement measures by contracting authorities during contracting procedures irrespective of the eventual value of the contract. Consequently, these provisions also apply to direct awards of contracts as referred to when stating that “in the case of a contract of a value for which neither Union nor national public procurement and concession award rules are applicable”. Although a majority of European Union or national provisions don’t apply to direct awarding procedures, there is no general exemption from these rules. Exemptions only exist as to very specific cases irrespective of the value of the contract.
Eventually, we also request a clarification on which cases falling under article 4(4) of the proposal don’t fall within the scope of procurement law.
Read full responseResponse to A European Health Data Space
1 Feb 2021
In light of the increasing digitalisation accelerated by the COVID-19 pandemic, the Austrian Social Insurances warmly welcome the Commission’s plan to establish a European Health Data Space (EHDS) which is safe, accessible and transparent. The current crisis has shown the great importance of timely cross-border exchange of data for the management of such a pandemic but also as a preventive measure for future cross-border threats.
Key principle should be in this context ensuring compliance with the existing provisions under the GDPR in order to generate broad acceptance of digital tools among citizens. The standards as to the quality of data included and to its anonymisation/synthetisation are crucial for an efficient, outcome-oriented use. In this regard, we would like to stress that harmonising these standards should not be a race to the bottom but based on the highest existing standard.
As to the objective of ensuring cross-border access to and exchange of health data in terms of primary use, we fully support a harmonisation of digital standards in order to support interoperability and portability of data. Especially for health systems, this will entail up-front payments due to changes and updates to the current formats and digitalisation processes. These costs should not be solely borne by Member States but supported by Union funds. Furthermore, a sound analysis of the possible implications of the cross-border use of healthcare services and products will be of utmost importance. Negative impacts concerning the independency and functioning of health systems have to be prevented by all means in order to fully respect Member States’ competences.
Concerning the use of the EHDS, we recommend differentiating clearly between primary and secondary use of health data. In our view, these are two completely different areas which need different technological solutions as well as a separate governance framework. Primary use is based on the principle of freedom of movement whereas secondary use is associated with competition within the Single Market.
The challenge of respecting data protection and at the same time improving quality of data for the benefit of the general public needs to be addressed. We thus call for a harmonised legally binding framework for the governance of the EHDS, esp. in the case of highly sensitive health data. We also agree with the principle of data altruism, namely that everyone should be able to contribute to the quality of the datasets included in the EHDS. However, this should also include the right to be forgotten as well as the possibility to withdraw consent or to opt-out. Questions arise in our view if citizens‘ data is included in social security information and how to deal with this right to opt-out.
In our view, establishing the EHDS for the exchange of synthetic data for the benefit of R&I is of utmost importance for the common good. We recommend implementing a centralised service point for generating and updating synthetic data.
When it comes to the use of RWD in the context of evidence generation for marketing authorisation and HTA procedures, the Austrian Social Insurances stress their concerns regarding a possible shift of risk from the pre- to post-marketing authorisation phase. Randomised controlled studies (RCT) with relevant comparators and endpoints should continue to be the gold standard for authorisation procedures. Exceptions should be based on sound reasoning and applied only in well-described cases complementing clinical trial data, and new concepts must neither endanger the safety of patients nor place an additional burden on healthcare systems.
Eventually, we call for a close involvement of representatives of the social security institutions in any future steps and decision-making processes due to their in-depth knowledge of daily practice. Especially in the cross-border context, we are observing several challenges for the implementation which need to be duly taken into account.
Read full responseResponse to Revision of the EU legislation on medicines for children and rare diseases
6 Jan 2021
In view of the steady increase in pharmaceutical spending and the relatively high prices of orphan medicinal products (OMP), the Austrian Social Insurance welcomes the revision of the EU legislation on OMPs and medicines for children. As mentioned in this document, the system of incentives can impact market competition aspects and indirectly influence availability of and access to medicines as well as the financial sustainability of national health systems. Therefore, it will be crucial to restore the balance in this area, esp. between orphan designation, marketing authorisation, measures to foster R&D and affordability. Key element to improve access is in our view a strengthened competition within the OMP and paediatrics market. This should be implemented not only through purely fostering faster market entry of generics/biosimilars by introducing a variable duration of market exclusivity but also by redefining the significant benefit concept in order to encourage R&D of alternative treatment options.
Although the Austrian Social Insurance welcomes the development and the timely market launch of innovative drugs, esp. in areas with a high unmet medical need (UMN), such as OMPs and paediatric drugs, the respective incentives must not be exploited for disproportionate price demands and profits. First and foremost, a harmonised, EU-wide applicable definition of UMN is needed to direct pharmaceutical R&D in areas without any suitable or existing therapeutic option. However, faster approvals do not automatically guarantee better supply of medicinal products. This has to be taken into account esp. when connecting newly developed drugs with EMA’s PRIME scheme and its subsequent accelerated assessment. Patient safety should by all means not be endangered by premature approvals when shifting the data generation to the post-marketing phase.
As to the respective incentives, the Austrian Social Insurance fully supports the foreseen review. Focus should be put on the market exclusivity as laid down in the OMP Regulation. In this regard, we would like to stress the fact that the number of OMPs increased constantly due to these incentives but the additional therapeutic value could often not be adequately established at time of marketing authorisation. Most of the OMPs, however, are marketed at relatively high prices, i.e. on average €4.400 per subscription in Austria. Re-evaluating the criteria for OMP status on a regular basis as well as a possible reduction of the market exclusivity as soon as the company's investments have been amortized and a reasonable profit has been achieved should be considered. With a view to a possible introduction of transferrable vouchers as an alternative to SPC extension for development of paediatric medicines, and for UMN in rare diseases, we urgently call for a sound analysis of its adequacy and proportionality as to the expected impact prior to any concrete steps. Moreover, as the Technopolis Study states, a majority of incentives foreseen are around orphan designation or around time of marketing authorisation. Hence, another important step would be the introduction of alternative push incentives. These could support tackling an earlier stage of the development process based on a common definition of UMN in order to better align basic research and to break up the clustering around cancer drugs. However, possible additional or alternative incentives should be duly analysed and evaluated prior to concrete further steps. And finally, we suggest to focus on a review of the current prevalence threshold to foster only R&D of products targeting areas with a real UMN. A thorough investigation of international definitions should guide this revision. The intention to explore alternative/additional criteria to identify specific rare diseases (option 2) is welcomed. Furthermore, the prevalence of all indications that a medicinal product is licensed for should in our view be combined when granting an orphan status.
Read full responseResponse to Green Paper on Ageing
14 Dec 2020
We welcome the European Commission’s initiative to launch a broad debate on the overall socio-economic effects of demographic change and to identify possible EU-level actions to mitigate these effects. We therefore acknowledge the intention to support the national social security systems in view of the impact on their sustainability in the field of old age, long-term care and health care. However, this has to be done very carefully while fully respecting the national systems and the subsidiarity principle as laid down in article 153 TFEU. In our view, it is crucial to fully use and implement properly the existing legislative framework prior to introducing new initiatives which could make processes more burdensome. In our view, the following aspects should be highlighted and receive highest attention when drafting the future Green Paper:
First and foremost, every initiative can only be successful if it remains implementable on a national level, i.e. in daily administrative management of social security systems. Additional barriers should be prevented. We therefore call for a close involvement of representatives of national social security systems in any future steps for the Green Paper and beyond.
As to demographic change and its consequent challenges for national pension systems and their long-term financial sustainability, it will be crucial to focus on increasing the effective retirement age and the labour force participation in particular but not only among older workers. According to the State of Health 2020 “a greater number of healthy life years generally means a healthier workforce, fewer early retirements due to health problems, and reduced or postponed long-term care needs” . Key priorities should therefore be measures for efficiently prolonging healthy active working lives and strengthening employability.
Increased health promotion among EU citizens will be key and we therefore call for an enhanced culture of health as to health promotion and prevention in all policies to put it in the centre of policy-making processes. A holistic approach supporting people to stay healthy has to be introduced at a very early stage to guarantee effectiveness, respective adjustments to the workplace equally included. Special focus should be put also on the issue of mental health. Equally important in this regard are effective rehabilitation and return to work strategies, e.g. part-time reintegration. This would not only help people to get back to work as quickly as possible but also provide them with the support they need to fully participate in the labour market. In this respect, a close link to existing and future initiatives will be important, i.e. the EU’s Beating Cancer Plan putting an emphasis also on prevention and reintegration.
Another important step would be to develop awareness-raising notably amongst younger generations as to the impact of decisions concerning their professional life on old-age pensions. This could help mitigating current (gender) pension gaps. Clear and concise pension forecast tools could support strengthened awareness-raising initiatives.
Eventually, we would like to stress the importance of measures to address shortages of healthcare professionals. Taking the right steps according to the national requirements to make these professions, especially concerning long-term care activities, more attractive.
Read full responseMeeting with Christoph Nerlich (Cabinet of Commissioner Nicolas Schmit), Eugenia Dumitriu-Segnana (Cabinet of Commissioner Nicolas Schmit)
20 Oct 2020 · implementation of the European Pillar of Social Rights, exchange concerning the circulating idea of a European Social Security Number
Meeting with Ines Prainsack (Cabinet of Commissioner Stella Kyriakides), Karolina Herbout-Borczak (Cabinet of Commissioner Stella Kyriakides)
14 Oct 2020 · Presentation of position by the Austrian Social Insurance on the Pharmaceutical Strategy and exchange of views.
Response to Intellectual Property Action Plan
14 Aug 2020
The Austrian Social Insurances welcome the initiative of the European Commission to modernise the current intellectual property (IP) framework in order ensure that the EU has in place well-calibrated and modern IP policies that contribute to the resilience and competitiveness of the economy, boost innovation and promote a coherent EU-wide approach to IP policies. As to the pharmaceutical sector, it will be of utmost importance to strike a balance between these objectives and the overarching priorities as mentioned in the upcoming pharmaceutical strategy, namely availability, affordability, sustainability and security of supply of pharmaceuticals.
As the roadmap states, the EU has already a robust IP framework to the benefit of the EU economy. Every change of this system should be based on a sound impact assessment in order to take only those measures that are really necessary. We acknowledge the need, as mentioned in the Industrial Strategy of 10 March 2020, to ensure Europe’s autonomy in strategic sectors, such as the supply with pharmaceuticals. Therefore, any steps towards the creation of a Unitary Patent system for the EU and the establishment of a European Patent Court are very much welcomed in order to ensure consistent application and enforceability of the current provisions. Nevertheless, the creation of a unitary patent for the EU must not lead to further prolongation of the exclusive right granted therein as patents hinder the development of generics and thus render competition of prices impossible. Furthermore, there is no evidence that patents increase innovation and productivity (Boldrin/Levine, 2013).
We also do support the harmonisation of the supplementary protection certificate (SPC) system in order to create a coherent granting procedure and to avoid multiple protection schemes of one product in different Member States. This would at the same time prevent anti-competitive behaviour through filing multiple applications for SPCs. However, any extension or strengthening of the IP framework, including SPCs, in order to incentivise industry to relocate production back to Europe should be duly analysed.
According to the 2008 impact assessment for Falsified Medicines Directive , 90% of APIs for generic medicines are sourced from India and China whereas many APIs for innovative medicines are already produced in Europe. Hence, in order to relocate production of generics back to Europe, amongst others to prevent medicine shortages, alternative incentives other than a stronger IP protection should be established. Possible measures other than patents could encompass license agreements, compulsory licensing or medicines patent pools , as have been created under the WHO-regime. They would provide a far more efficient means to enhance availability and affordability of medicinal products. Possible misuse of current incentives and monopolisation through a stronger IP framework are contra-productive and should be prevented. Hence, a close alignment of the future European IP framework with the European pharmaceutical and industrial strategy is essential.
Another important issue from the point of view of social security is a much needed European approach to AI and IP protection. Clearly, any future European IP system needs to provide for the protection of innovative solutions through the application and deployment of AI systems. We do agree with the European Commission concerning a necessary review and adjustment of the current IP framework according to the state-of-the-art of technological development. Regarding the issue of sharing out IP rights, respective instruments should be created in order to provide for equal participation of every right holder in the IP protection scheme. This includes rules on equal exchange and fair use of data that has been used to create the innovation protected by IP rights.
Read full responseResponse to Legislative framework for the governance of common European data spaces
30 Jul 2020
The Austrian Social Insurances welcome the aim of the roadmap concerning the legislative framework for the governance of common data spaces, namely to create a Single Market for data and therefore to improve access to and use of data. Ensuring compliance with the existing provisions under the GDPR should be the overarching principle in order to generate broad acceptance of digital tools among European citizens. Everyone should be able to contribute to establishing high-quality datasets and to increase their interpretability. However, this also includes the right to be forgotten as well as the possibility to withdraw consent. The current COVID-19 pandemic has illustrated the importance of timely electronic cross-border exchange of data for the (effective) management of and recovery from such a pandemic but also as a prevention measure for future cross-border threats.
In our view, establishing such a data space for the exchange of synthetic data for the benefit of R&I is of utmost importance for the common good. We recommend implementing a centralised service point for generating synthetic data. This would ensure the transformation of relevant data according to the intended use, improving the quality of the result and at the same time preventing an individual’s identification. Consequently, the Commission should implement measures to unleash the full potential of synthetic data. In this context, we support the effective use of strategic investment in digital programmes, as foreseen in the multiannual financial framework.
The challenge of respecting the right to data/privacy protection and at the same time improving the quality of data for the benefit of the general public needs to be addressed. We therefore call for a harmonised legally binding regulatory framework for the governance of data spaces, especially in the case of highly sensitive, high-risk healthcare data.
We would particularly like to highlight the aim of the roadmap to facilitate the use of data held by the public sector and donated by individuals for the common good for R&I purposes. Hence, the future framework should be based on the principle of Open Science regarding access to and use of data. Findings and results generated on the basis of these data should be made publicly accessible, preferably through a common platform. Moreover, end results such as products and/or services as well as the used and generated datasets should be available to all EU Member States. Transparency and traceability is key in this regard as is enabling access by national competent authorities and social security institutions. Data as such should not only benefit industry but also all other relevant stakeholders contributing to the data spaces and therefore creating a real added value for society. We thus call on the Commission to take into account facilitated access to data and to foster responsible use of data as key priorities of the future governance framework of the data spaces.
To facilitate the interpretability of datasets, the method used to generate these data has to be transparent. It should be based on harmonised standards for high-quality data formats to ensure interoperability, comparability and compatibility. We strongly welcome the proposal to establish processes and bodies/structures. This would not only strengthen the surveillance of data flow within the data spaces but also reinforce the implementation of a level playing field for all relevant actors.
Eventually, we recommend establishing a platform for participating institutions to submit their metadata descriptions (data catalogues) in a standardised format. This should include a description of the granularity and structure of datasets as well as possible limitations. Equally important is that the results from processing these data are publicly available. This would stress the respective benefit to society and thus increase acceptance among EU citizens and foster exchange within the scientific community.
Read full responseResponse to Pharmaceutical Strategy - Timely patient access to affordable medicines
6 Jul 2020
We welcome the initiative to help ensuring Europe’s supply of safe and affordable medicines to meet patients’ needs and support the European pharmaceutical industry to remain a world leader as well as to keep its strategic autonomy. We also appreciate that our concerns regarding the pressure on the financial and fiscal sustainability of healthcare systems due to increased prices has been taken into account. This has to be kept high also on the agenda when drafting the future pharmaceutical strategy. We therefore acknowledge the European Commission’s intention to modernise and better equip the national healthcare systems in order to ensure deployment and uptake of innovative solutions. However, this has to be done very carefully while fully respecting the different organisation of the national systems and the subsidiarity principle as laid down in article 168(7) TFEU. Especially the COVID-19 pandemic has shown the importance of securing equitable supply with pharmaceuticals. In this respect we also support the intention for better coordination in public health responses in order to tackle such kinds of pandemics falling within the remit of the Union’s competences in healthcare and using the full potential of existing legislation.
In our view as social insurances, the following aspects should be highlighted and receive highest attention:
Key objective of the future pharmaceutical strategy should be the revision of the current regulatory framework, especially in view of possible incentives and market failures. Furthermore, a clear definition of unmet medical need should underpin such decisions. Eventually, it is of utmost importance also to progress on the current negotiations around the regulations on orphan medicinal products and paediatrics as well as HTA. Moreover, we think that a separate regulation on antibiotics and vaccines is needed.
We also fully support the Commission’s call for more transparency in the sector including information on the real costs of R&I, marketing costs and revenue, including also possible legislative acts. Ways to incorporate public investments in national price setting policies should not exclusively focus on downstream measures such as price negotiations. Concerning support for issues relating to cost-effectiveness, pricing and reimbursement and procurement practices, the question remains if regional initiatives between individual Member States, such as Beneluxa, fall also within the remit of this initiative. This would not only help to define an adequate average price for pharmaceutical products, which is at the same time affordable and doesn’t put healthcare systems under financial pressure. In this context, we also call for a close link to the initiatives concerning IP protection as mentioned in the Commission Communication “A new industrial strategy for Europe”.
With respect to medicine shortages, we call for a balanced approach between diversification of production sites and measures to re-locate production of APIs and starting materials back to Europe. Creating a level playing field for EU companies through harmonised international quality and safety standards should not only address also environmental risks but also, and even more important, social protection as well as health and safety requirements at the production sites.
As to the topic of the use of real world data (RWD) in marketing authorisation procedures a clear statement why these data has been considered “fit-for purpose” should be provided by regulators and should be applied only in exceptional, well-described cases complementing clinical trial data. Evidence based on clinical studies should however remain the gold standard. The inclusion of RWD should be based on sound reasoning and outline the purposes as well as the impact on any subsequent regulatory decision. Therefore, quality standards need to be defined according to their intended use as well as consequences for marketing authorisation holders in case of non-compliance
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