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Hellenic Association of Pharmaceutical Companies

SFEE

The Hellenic Association of Pharmaceutical Companies (SFEE) represents one of the most innovative, productive, and extrovert sectors of the national economy.

Lobbying Activity

Meeting with Olga Solomon (Head of Unit Health and Food Safety)

17 Feb 2025 · Exchange of views on the reform of the General Pharmaceutical Legislation, discussion on the proposed system of incentives

Meeting with Sakis Arnaoutoglou (Member of the European Parliament)

24 Sept 2024 · Meeting over EU pharmaceutical legislation

Response to Health technology assessment - Joint clinical assessments of medicinal products

1 Apr 2024

The EU HTA Regulation represents a step-change in the assessment of clinical evidence of new technologies at EU level and has the potential to accelerate and improve access to patients as well as reduce inefficiencies and duplications, goals that the pharmaceutical industry shares. The EU HTA Regulation is a reality and will start to affect HTA bodies, health technology developers and their technologies as well as patients and clinicians in less than 10 months time. The success of the EU HTA Regulation is contingent on the ability of the system to deliver high-quality JCA reports which provide added-value to national decision-makers. As such, the JCA process needs to: i. facilitate early engagement with the health technology developer (HTD), to ensure a timely and optimally informed start of the process and to enable the systematic exchange of relevant information with the HTD. ii. to provide all participants with the necessary information and evidence for the scoping and assessment. iii. guarantee sufficient time for HTDs to conduct the relevant analyses required for preparing and finalizing their clinical evidence submission dossier. iv. allow assessors sufficient time to review the JCA dossier and to develop a high-quality JCA report. EFPIA is concerned about several glaring shortcoming in this draft JCA implementing act, especially regarding the workability of the JCA process, where it undermines the capacity of the HTD (from SMEs and biotech to larger pharmaceutical companies) to provide a good quality submission to the assessors and co-assessors. Several reasons drive this concern: the unbalanced time allocation between scoping and submission stages, the absence of visibility on submissions scope coupled with the expected size/complexity of the assessment scope driven from a mechanistic need to satisfy all needs of all Member States and the lack of meaningful participation of the HTDs at key steps of the process. EFPIA strongly believes that the draft JCA implementing act can set the path towards a successful EU JCA system if it recognizes the role key stakeholder in the process and enables a rebalancing of workload in line with respective remits and obligations. In practice, this means that: The assessment scope should be finalized within 90 days of the start of the JCA procedure and the HTD should have at least 135 days to prepare a high-quality submission dossier. The HTD should have the opportunity to leverage all relevant information, evidence, and knowledge as a key input into the definition of the assessment scope. The HTD should have an opportunity to meet and discuss with the assessor/co-assessor its views on the draft assessment scope. The HTD should have visibility on the draft assessment scope proposed by the assessor/co-assessor as well as on the PICO survey responses from Member States (in an anonymized manner) at the earliest possible stage, to be able appropriate time to submit a high-quality submission response. These procedural changes are the minimum necessary to safeguard the future JCA system. Additional detailed considerations and proposals are listed in the annex of this response. EFPIA stands ready to meaningfully contribute to the success of the EU HTA Regulation for the benefit of EU patients. The Hellenic Association of Pharmaceutical Companies (SFEE) is fully aligned with the above evaluation of EFPIA. The EU HTA is an opportunity and for that to happen, the recently established Greek National HTA Body needs to be adequately staffed, both in numbers and expertise. Technical assistance in the period before the implementation is crucial, as is the continuous training and support after the implementation. Furthermore, all the legislative changes that will facilitate the national alignment with the EU Regulation need to happen within the short period of the next few months and as such, the Greek Government needs to meet the strict deadline.
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Response to Evaluation and revision of the general pharmaceutical legislation

8 Nov 2023

The reform of the EUs pharmaceutical sector is a milestone of the European Health Union and a crucial step in our collective effort to pave the way towards a healthier, more resilient, and more equal Europe.SFEE fully supports the objectives of enhancing the availability and accessibility of medicines, while fostering a competitive innovation environment in Europe. We welcome the proposal to future-proof the EU regulatory framework, maximising the use of expedited pathways, optimising regulatory decision-making processes and reducing unnecessary administrative burdens.Greece, a small country which recently exited the fiscal adjustment programs, continues to face challenges in terms of patients' access to medicines and especially innovative medicines. It takes Greek Patients 674 days to access new medicines.What the proposal fails to address is the root causes of the unavailability and delay to innovative medicines, which are multifactorial. A characteristic example of an access barrier set by the State is the legislation of external criteria as a prerequisite for HTA application by MAH. The external HTA criterion (reimbursement in 5/11 Eu countries with established HTA systems) introduces delays in patient access to new medicines for a significant period after EMA approval as no evaluation of submissions can be initiated before this criterion is fulfilled.Extremely high uncontrolled level of paybacks could also affect the launch of a new medicine since many innovative products cannot enter the market due to non-sustainable net prices derived.For the period 2018-2021, of the 168 innovative medicines that received a central authorization from the EMA, 90 medicines are available to the Greek patient, i.e. 54% of approved innovative medicines compared to 47% EU average In particular, 58% of the new medicines available in Greece, against the European average of 37%, are under a limited availability or reimbursement, mainly reflecting the medicines that are available through IFET and the Electronic Pre-Authorization System (EPS).Finally, regarding the time required from the date of approval of the drugs by the EMA to the date of their reimbursement by the health systems,Greece significantly lags behind the reimbursement time of a new treatment compared to the European average, as this is calculated equal to 674 days (against 517 days in the EU countries).In addition, Greeces healthcare system is characterised by low public funding. When it comes to the pharmaceutical industry, the lack of public funding and the imposition of high levels of mandatory discounts to the pharmaceutical industry (the highest in Europe) have caused an unsustainable environment creating great challenges to patients access. Similarly, patients' contribution has steadily increased. The reduction in public outpatient expenditure over the period 2012-2021 by approximately 31% resulted in a significant increase in industry contribution over the same period by 458% and patient contribution by 59%. Additionally, Greece has among the lowest prices in the European Union, thus resulting to medicines withdrawals and shortages driven by parallel exports.Contrary to Commissions intentions, SFEE believes that the likely net impact of the proposals will undermine Europes competitiveness and slow the research, development and delivery of new treatments and vaccines in Europe. We have strong concerns regarding the Commission proposal, which undermines the predictability of the existing IP framework in the EU. This will not only fail to improve access to medicines for European patients but rather harm the innovation pipeline which is not aligned with the intent of making Europe an attractive Innovation hub.Our industry is in a unique position to help create a healthier, more resilient future and prosperous future for Greece and Europe.SFEE is committed to working with all stakeholders to ensure that all Greek patients have access to the most innovative treatments.
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Meeting with Petros Kokkalis (Member of the European Parliament)

7 Feb 2023 · Pharmaceuticals strategy

Meeting with Margaritis Schinas (Vice-President)

8 Apr 2022 · Pharma strategy in EU and Greece

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

5 Jan 2021

Hellenic Association of Pharmaceutical Companies (SFEE) members are committed to ensuring that unmet needs are addressed and that available treatments reach all European patients. Children and rare disease (RD) patients have greatly benefited from the progress achieved through the Paediatric & Orphan Regulations. The Paediatric Regulation is meeting best-case expectations from its impact assessment conducted in 2004. The Orphan Regulation has incentivised the pharmaceutical sector to deliver treatments for up to 6,3 million patients. Any revision of the incentives should be designed to keep and improve Europe’s strong basis for innovation and should avoid measures aimed to address affordability issues which are best dealt with elsewhere. Any process to identify unmet needs must build on a multi-stakeholder discussion and include inter alia patients and their caregivers. Said system must also spill over to and be recognised by downstream decision-makers, ie HTA bodies and payers. Reducing rewards for fulfilling the PIP obligations or reducing incentives to focus only on ultra-RD where no treatment exists or on first in class innovation fail to understand the science behind biopharmaceutical research. Such measures will not redirect R&D into areas of needs but rather risk undermining Europe’s attractiveness as a region for innovation. Any legislative change needs to ensure that Europe remains competitive, supportive of innovation and attractive for R&D investments, in addition to providing fast access for as many patients as possible. Such measures will not redirect R&D into areas of needs but rather risk undermining Europe’s attractiveness as a region for innovation. Limiting the RD-designation criteria to less prevalent diseases risks leaving out significant numbers of pathologies and patients. The concept of overcompensation is not established: the staff working document (SWD) showed that only 14% of OMPs have yearly turnover of >€100 million. Making rewards and incentives conditional on launch obligations fails to understand the economics behind biopharmaceutical research and the complexities of launching medicines across the EU. SFEE calls on the Commission to work with stakeholders and urgently identify the root causes of access differences to find targeted solutions which are multifactorial and cannot be reduced to company decisions. Any access solutions will require a close collaboration of national healthcare systems on issues such as pan-European evidence generation, meaningful joint clinical assessments, and novel pricing and payment models. They require solidarity between Member States (MS), a recognition that wealthier EU MS should not benefit from the lower prices that ought to be available, in the interests of patient access, to poorer MS. SFEE calls on the Commission to consider all options through a thorough impact assessment, including those identified as ‘baseline’ and to acknowledge that their SWD is based on data up to 2017, which neither reflects the actions agreed in the 2018 EC-EMA paediatric action plan, nor the Commission notice 2016/C 424/03 on the Orphan Regulation or scientific and regulatory progress. We stand ready to work with the Commission to ensure future development of medicines for patients.
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Meeting with Margaritis Schinas (Vice-President) and

1 Oct 2020 · EU Health Policies

Meeting with Christos Stylianides (Commissioner)

29 Nov 2016 · exchange of vies on Pharmaceutical products distribution in refugee camps in Greece