OpenLobby.EU
Explore

European Industrial Pharmacists Group

EIPG

E.I.P.G.

Lobbying Activity

Response to Critical Medicines Act

26 Feb 2025

EIPG members fully support the objectives and ongoing efforts to ensure sustainable and reliable access to critical medicines. The participation of a heterogeneous group of stakeholders to submit ideas and contributions to support the development of the draft law to integrate proposals from a wide range of perspectives and expertise is surely the most appropriate approach. It is essential that all stakeholders adopt a patient-centric approach. Managing distribution during disruptions and crises by prioritising the medicines identified as critical is a key competence. In the past, we have noticed that national medicine authorities have been very reluctant to provide a list of critical medicines because they fear it touches on a competitively sensitive area where one manufacturer's medicine could be on the critical list and another's not, potentially causing competitive inequality. In the future, there must be clarity on who created the list and the potential role of the national medicines authority. When compiling its list, the EMA needs to consider country-specific differences, treatment practices, and clinical guidelines more. Additionally, careful consideration should be given to potential market dynamics and disruptions regarding stockpiling. Many countries are already building their own crisis stockpiling models. There is a significant difference between the origin of Europes active pharmaceutical ingredients (APIs) in the supply chain for innovative products and those for generic medicines. The majority of all APIs for innovative products come from Europe whereas the vast majority of all APIs come from Asia. It seems that a large number of APIs for critical medicines are generics. Off-patent medicine pricing is competitive, so extra care is needed with procurement procedures. Strengthening the manufacturing capacity in the EU (reshoring APIs from Asian countries) is likely to take many years, despite the availability of financial incentives. This is mainly because of technical and environmental issues in both regions. A particular focus should be placed on developing a coordinated plan, including the agreement on a list of API priorities. For many years, in most European countries, the European Medicines Verification System (EMVS) could have made available levels of finished product stock in the supply chain. Large numbers of industrial staff and their necessary resources and many healthcare practitioners have spent their time and effort inputting data, allowing packs to be dispensed and exported, and recording the stock available for prescription products. EMVS should provide information on finished products as soon as there is a critical shortage. If the EU introduces broadly applicable obligations for critical medicines, the "stockpiling period" must be extended to avoid new and significant availability issues in the market as everyone stocks up simultaneously. It is essential to understand well in advance what the critical product list will entail and what new obligations it will impose at the manufacturer/wholesale level. The expectations of authorities and marketing authorisation holders (potentially considering commercial services and functionalities in their ERPs and other systems) should be clear
Read full response

Response to Evaluation and revision of the general pharmaceutical legislation

8 Nov 2023

Since it was not possible to preview the attached file I also include the feedback from EIPG here: EIPG POSITION PAPER ON THE REVISED EUROPEAN PHARMACEUTICAL LEGISLATION The European Industrial Pharmacists Group (EIPG) is a European association representing the national, and professional organisations of pharmacists employed in the pharmaceutical or allied industries of the Member States of the European Union, the European Economic Area, or European countries having a mutual recognition agreement with the European Union on compliance control of regulated medicines. The Association is a Professional Group and is independent of all political parties and/or movements. One of the underlying premises of the Association is to develop the pharmaceutical and allied industries in the interests of public health. EIPG welcomes the opportunity to comment on the proposed revision of the European Pharmaceutical Legislation, which we see as important to the patients within the European Union. Sustainability and Green Pharmacy EIPG completely agrees with the need for sustainability within the pharmaceutical industry. However, this should be encouraged on a global level as to do so within Europe alone could put European manufacturing sites at a commercial research and development disadvantage concerning third-party countries. To this end, EIPG has been debating what industrial pharmacists can do to help decrease the potential environmental impact from research, formulations, manufacturing conditions and product packaging to produce environmentally friendly medicinal products. We anticipate far greater discussion of green pharmacy. EIPG wishes to encourage clinical trials and manufacturing within Europe and the revised pharmaceutical legislation does not appear to support this fully, therefore, the European Commission should consider the impact of the revised legislation on the ACT-EU initiative. Security of Supply Although post-Covid the European Commission, the EMA and National Authorities have been taking a far greater interest in addressing shortages, they are addressing containment measures and not concentrating on the root causes. As an example, it requires a better understanding of the pharmaceutical industrys manufacturing business model for established products because Europe should not be dependent on third-party countries for the large majority of active ingredients and the manufacture of many generic pharmaceutical products supplied to EU patients who are at the heart of our health systems. Regulatory Data Protection The complexity of the new modular system and the possibility of reduced exclusivity periods could disincentivise the launch of new drugs. The impact of the legislation aiming to decrease disparities in access to medications across EU countries by offering two additional years of exclusivity to companies that launch in all member states within two years is admirable. However, the practicality of this goal is challenged by the current multiyear process required for a drug to reach the market with full reimbursement across the 27 member states, leading to drug launches well beyond the two-year target. EIPG suggests that regulatory data protection is amended in a way to keep innovation in the pharmaceutical industry and also to allow patients early access to medicines. November 8th, 2023
Read full response