Forum of International Research and Development Pharmaceutical Companies, EIG
FarmaForum
Forum of International Research and Development Pharmaceutical Companies, EIG (FarmaForum) is a representative of innovative pharmaceutical industry in Slovenia.
ID: 786313251884-04
Lobbying Activity
Response to Critical Medicines Act
3 Jul 2025
Forum of International Research and Development Pharmaceutical Companies (EIG), the Slovenian innovative pharmaceutical industry association, supports the European Commissions objective to strengthen the resilience of pharmaceutical supply chains and improve access to critical medicines across the EU. Achieving these goals requires implementation that is risk-based, proportionate, and aligned with the Unions broader policy and regulatory environment. It is vital that the Critical Medicines Act (CMA) strengthens, rather than complicates, existing frameworks while preserving Europes attractiveness for investment in innovation. To avoid unintended consequences, the CMA should target true vulnerabilities in supply, based on clear, product-specific criteria. Assessments of supply risk must rely on concrete indicators such as a products historical shortage record, manufacturing complexity, epidemiological data and clinical importance. Reliance on less meaningful proxies, including supplier concentration or sourcing geography, risks misidentifying secure or highly specialised products as vulnerable. This would not only dilute the intended focus of the Act but could also impose unwarranted regulatory burdens that undermine efficient supply. The concept of medicinal products of common interest should be applied strictly to products for which persistent and verifiable access problems exist. A possible threshold might include medicines that remain unavailable in at least three Member States several years after authorisation. This would ensure that policy responses are directed at genuine access issues without overreach. Public procurement can indeed contribute to greater supply chain resilience, provided that it moves beyond lowest-cost criteria and includes multi-winner guidance. A value-based, multi-criteria approach is needed - one that rewards supply security, environmental sustainability, and clinical value. Collaborative or joint procurement should be a measure of last resort, limited to medicines of common interest, vulnerable critical medicines, or those needed in health emergencies. Implementation of the CMA must also be coherent with broader EU policies. In particular, it is critical to avoid misalignment with environmental and chemicals legislation that could inadvertently create new obstacles to pharmaceutical manufacturing. A consistent, cross-policy approach will be essential to ensuring that CMA is both effective and feasible. Provisions related to contingency stock obligations must be carefully calibrated. Requirements should apply only where a product is confirmed to be vulnerable and should be governed by a harmonised EU framework that replaces divergent national rules and leverages EU solidarity mechanisms. Flexibility on storage formats and locations is essential, and effective implementation will depend on sustained dialogue with industry partners. Data-sharing obligations must remain targeted, proportionate, and non-duplicative. The Act should prioritise the use of existing platforms such as the EMVS, ensuring that any additional requirements address concrete and actionable information gaps. Lastly, international cooperation should play a central role in the EUs supply resilience strategy. Strategic partnerships with like-minded countries are essential to diversify sourcing and secure global supply chains. Resilience should be defined by the robustness and flexibility of the network, not by geographic location alone. Overemphasis on localisation risks fragmenting the internal market and reducing overall security of supply.
Read full responseResponse to Critical Medicines Act
21 Feb 2025
Please see attached the feedback from the Slovenian Inovative Pharma Industry Association
Read full responseResponse to Health technology assessment - Joint clinical assessments of medicinal products
27 Mar 2024
FarmaForum embraces HTA Regulation to fulfill the objectives of ensuring timely and improved access to medicines for patients, while also reducing inefficiencies and duplications across Europe. An inclusive and collaborative approach of all stakeholders in the process will enable the successful implementation of EU HTA and facilitate the smoother adoption of JCA reports in decision-making at the national level. Should Health Technology Developers (HTDs) not systematically participate in the process at the EU level, there is a risk that certain critical issues may not be addressed in a timely manner, causing delays in access at the national level. Even though JCA report is not legally binding, it still holds weight because national authorities consider it when making decisions. The absence of HTD in defining the assessment scope and during the assessment might result in varying outcomes across countries, which could undermine the very goals of the HTA Regulation: timely decisions on patient access in national healthcare systems. An early start of JCA is critical to allow sufficient time for a high-quality JCA. The appointment of the assessor and co-assessor at the time of pre-notification from the HTD would allow the JCA procedure to start simultaneously with the EMA procedure and allow more time for scoping, dossier preparation, and assessment. Adequate time must be allocated to the HTD to deliver a comprehensive and high-quality dossier. Another prerequisite for the HTD to deliver a high-quality dossier is its active involvement in the scoping phase. This means the HTD shall be invited to the assessment scope consolidation meeting as well as the assessment scope explanation meeting by the JCA subgroup. In the limited time available for JCA, the assessment scope consolidation meeting specifically would give the assessor and co-assessor the opportunity to gather further information from the HTD and provide the HTD the opportunity to ask clarifying questions. The JCA Subgroup should invite the HTD to an assessment scope explanation meeting no later than 5 days from the day on which the HTA secretariat shares the finalized assessment scope with the HTD. Overall, a more balanced time allocation between the HTD and the assessor and co-assessor should be secured to allow the workability of the JCA process. FarmaForum advocates that the analysis should be limited to the data essential for assessing the clinical benefits. Only the necessary analysis and endpoints for decision-making should be included, rather than an exhaustive array of information. The summary report is an important part of the assessment report. It should be translated into all EEA languages to increase national uptake and to speed up national access timelines. The Commission shall protect the rights of HTD for the protection of trade secrets, commercially confidential information, as per Directive 2016/943. Information contained in the submitted documentation and requested by the HTD to be treated as confidential should not be published. The Commission should not publish the underlying documentation of the dossier of the HTD because it contains highly confidential information. Transparency is generally seen as a positive value, yet it is important to ensure that the pharmaceutical industrys trade and business secrets remain confidential. Failing to protect these could potentially result in reduced investment in research and development. The JCA considers solely the clinical domains of HTA according to the HTA Regulation definition. Organizational and societal aspects are an important part of HTA assessments, especially the existing burden of the health condition, the patient, and the caregiver perspectives. However, they strongly belong to the national context and should therefore remain the responsibility of the national appraisals of the MS. Besides that, to keep the dossier manageable, non-clinical domains should routinely not be included in the JCA dossier.
Read full responseMeeting with Klemen Grošelj (Member of the European Parliament)
14 Feb 2024 · Pharma Package
Meeting with Ljudmila Novak (Member of the European Parliament)
9 Nov 2023 · Pharmaceutical Legislation Package