{"id":108127,"date":"2024-04-12T18:01:05","date_gmt":"2024-04-12T15:01:05","guid":{"rendered":"https:\/\/www.sfee.gr\/?p=108127"},"modified":"2024-04-12T18:11:11","modified_gmt":"2024-04-12T15:11:11","slug":"the-pharma-legislation-has-a-long-way-to-go-to-restore-europes-competitive-edge","status":"publish","type":"post","link":"https:\/\/www.sfee.gr\/en\/the-pharma-legislation-has-a-long-way-to-go-to-restore-europes-competitive-edge\/","title":{"rendered":"The Pharma-Legislation has a long way to go to restore Europe\u2019s competitive edge"},"content":{"rendered":"

EFPIA responds to the European Parliament Plenary vote<\/strong>: <\/strong><\/p>\n

Despite improvements, the Pharma-Legislation has a long way to go to restore Europe\u2019s competitive edge<\/strong>.<\/strong><\/p>\n

On 10 April 2024 Members of the European Parliament adopted their position on the EU Pharmaceutical Legislation.<\/p>\n

 <\/p>\n

Commenting on the vote, Nathalie Moll<\/strong>, EFPIA Director General<\/strong>, said:<\/p>\n

\u201cThis is a significant moment for the research based pharmaceutical industry. Today\u2019s vote sets out how Europe sees the future of health and life science research and innovation and patient care in the region. <\/em><\/p>\n

Ensuring patients have faster, more equitable access to new medicines – and how Europe can close the investment gap on other parts of the world – has been the subject of significant debate in the past months. <\/em><\/p>\n

We believe that the Parliament has voted through certain amendments that have enhanced the European Commission\u2019s original proposals to develop a future-proof regulatory framework. A move welcomed by industry. <\/em><\/p>\n

MEPs have also taken the pragmatic, common sense step to avoid making two years of a company\u2019s regulatory data protection (RDP) dependent on a new medicine being available in all 27 EU members states within 2 years of getting marketing authorisation. They have recognised that the majority of factors determining whether a medicine is made available or not, are out of the control of an individual company. Rather than waiting for legislation that is not designed to address medicines access in Member States, we are convinced that by getting around the table with patients, payers, providers and national policy makers, we can find workable solutions to improve access for patients today.<\/em><\/p>\n

Despite some improvement to the original European Commission proposals, the position adopted in the Plenary reduces regulatory data protection by six months. It is difficult to understand how reducing incentives to research, develop and manufacture new medicines and vaccines could ever be in the best interest of Europe or European patients, particularly at a time when Europe recognises that it needs to boost competitiveness to compete for global investment with ambitious nations like the US and China.<\/em><\/p>\n

The challenge now is for policy makers to align the next iteration of the pharmaceutical legislation with the recurrent calls by European leaders to boost European competitiveness and build a resilient industrial future. As the industry that contributes more to the EU trade balance than any other sector, we believe that health and life sciences should be at the heart of building that future.<\/em><\/p>\n

\u00a0<\/em>This can only be achieved through the implementation of coherent and complimentary policies within the revision of the Pharmaceutical Legislation that will strengthen, not weaken the research based pharmaceutical industry in all member states.\u201d<\/em><\/p>\n

 <\/p>\n

===========================================================================<\/p>\n

Further EFPIA commentary on individual aspects of the Plenary vote<\/strong><\/p>\n

On the regulatory framework <\/u><\/strong><\/p>\n

\u201cRetention of the Commission’s proposals to introduce a regulatory sandbox is a big step towards future-proofing the regulatory framework. The effectiveness\u00a0of the sandbox provisions in helping bring future breakthrough innovations to EU patients could be maximised by ensuring the sandbox is applicable across several legislative frameworks and not limited to the pharmaceutical legislation. <\/em><\/p>\n

\u00a0<\/em>Administrative burden will be reduced with the proposal of electronic-only patient information for medicinal products\u00a0directly administered by healthcare professionals.\u00a0However, we are missing an opportunity by not giving the European Commission the power to determine when the time is right for all leaflets to be available electronically only. EFPIA does, however, believe that wherever necessary, a paper leaflet should also be available for those patients who need it. <\/em><\/p>\n

\u00a0<\/em><\/p>\n

On Antimicrobial Resistance (AMR) and the retention of TEV proposals<\/u><\/strong><\/p>\n

\u201cThe European Parliament’s inclusion of AMR incentives, such as the transferable exclusivity voucher (TEV) in its text marks a significant step in addressing the AMR challenge. It will be important for these measures to undergo further refinement during legislative negotiations to ensure their effectiveness.<\/em><\/p>\n

The revision of the pharmaceutical legislation offers a unique chance for Europe to take a leadership position in the global fight against AMR. We look forward to continued conversations with all partners to identify policy solutions capable of realising this goal.\u201d<\/em><\/p>\n

 <\/p>\n

On orphan medicines <\/u><\/strong><\/p>\n

\u201cRobust and reliable incentives remain essential. In order to address the needs of patients suffering from rare diseases, incentives\u00a0should be strengthened as the economic case for investment in rare diseases is only marginal. <\/em><\/p>\n

A simple and predictable system of orphan incentives with a strengthened market exclusivity baseline, and modulation that considers the specific challenges related to a given type of development, without using the graduation of HUMN, would have been the better choice for European Rare Disease patients. We hope that Member States will consider these key ingredients and enable an improved ecosystem for research and development of solutions for rare disease patients.<\/em><\/p>\n

It is great to see that the idea of a European Framework for Rare Diseases is included to foster more coordination of policies and programmes.”<\/em><\/p>\n

\u00a0<\/strong><\/p>\n

On the definition of Unmet Medical Need (UMN)<\/u><\/strong><\/p>\n

\u201cWe are pleased to see that under\u00a0the European Parliament proposals,\u00a0all relevant\u00a0stakeholders will be invited to actively engage in identifying unmet medical needs from different perspectives.\u00a0To ensure a patient-centric definition, the value of innovation has to be\u00a0acknowledged and advances in prevention, treatments and care encouraged.\u201d<\/em><\/p>\n

\u00a0<\/em><\/p>\n

On paediatrics<\/u><\/strong><\/p>\n

\u201cIn the field of paediatrics, we need to build on the current legislation and create<\/em> an ecosystem fostering effective research into medicines for children, particularly where unmet medical need exists. The introduction of paediatric investigation plans based on mechanism of action is a step in the right direction, but this so far lacks the appropriate framework to ensure that the expanded research obligations lead to scientifically and clinically meaningful, and feasible R&D that benefits paediatric patients and does not place undue burden on pharmaceutical innovation. Furthermore, this ecosystem needs to make paediatric medicines available where actual patient needs and demands exist across the EU.\u201d<\/em><\/p>\n

 <\/p>\n

On vaccines<\/u><\/strong><\/p>\n

\u201cWe welcome the adopted vaccine definition, as it aligns with the EMA\u2019s guidelines for the assessment of vaccines and allows for future innovation in the field of immunisation. Vaccines are unique medicinal products, with complex manufacturing processes, long lead times and very specific regulatory requirements and market access pathways. For instance, in most of the EU countries, routine vaccines must be listed in the national immunisation programmes to be eligible for a pricing and reimbursement procedure. We regret not to see vaccines specificities fully covered by the adopted texts, especially when it comes to the obligation to file for a pricing and reimbursement procedure, which could lead to a suboptimal and unequal access to immunisation, and therefore, an inadequate protection of the European population.\u201d<\/em><\/p>\n

\u00a0<\/em><\/p>\n

On medicines shortages<\/u><\/strong><\/p>\n

\u201cThere are a number of positive elements within the text approved by the Parliament, including proactive consultation with all stakeholders on the Critical Medicines list, the possibility for the European Medicines Agency to assess Member States\u2019 measures to tackle shortages and how they impact on other countries, as well as plans by the Commission to work with the ECDC to build reliable forecasts of potential threats and shortages.\u00a0<\/em><\/p>\n

However, EFPIA continues to have concerns around a few proposals. There remain no plans to use readily available data from the Falsified Medicines Directive (EMVS) repository to monitor shortages, we believe this is a missed opportunity. Extending the current 2-month notification period for temporary supply chain disruptions to 6 months will likely lead to\u00a0 unnecessary notifications which could reduce visibility of\u00a0actual\u00a0shortages. Shortage Prevention Plans (SPPs) should be reserved for critical medicines.<\/em><\/p>\n

A new requirement to include labelling information on each individual dose of blister packs, would also lead to significant disruptions in the manufacturing processes.\u201d<\/em><\/p>\n

\u00a0<\/em><\/p>\n

On manufacturing<\/u><\/strong><\/p>\n

\u201cWe are encouraged to see platform technology master files having been adopted\u00a0by the European Parliament, leading to shorter approval times for innovative medicines.<\/em><\/p>\n

On the other hand<\/em>, the\u00a0proposal to enforce environmental and workers\u2019 safety via\u00a0Good Manufacturing Practices Inspections risk delays\u00a0to the approval of medicines in the EU and in third countries, and <\/em>ending the existing <\/em>mutual recognition\u00a0agreements on GMP inspections with non-EU countries.\u00a0 Asking GMP inspectors to enforce environmental and workers<\/em>\u2019<\/em> safety, when this has already been done by Inspectors \u00a0specialised in environmental and workers rules is a waste of resources.<\/em>\u00a0This will also be\u00a0difficult to enforce outside\u00a0of\u00a0\u00a0the\u00a0EU\u00a0\/\u00a0EEA.\u201c<\/em><\/p>\n

 <\/p>\n

On environmental\u00a0proposals<\/u><\/strong><\/p>\n

“The\u00a0pharmaceutical industry recognises the\u00a0importance of\u00a0Environmental Risk Assessments\u00a0(ERA)\u00a0in assessing the\u00a0potential impact of human medicines and their manufacture on the environment.\u00a0To proactively address and manage this, we\u00a0propose an extended ERA\u00a0to proactively address and manage the environmental risks associated with the patient use of human medicinal products. We do, however, have concerns over provisions adopted by the European Parliament\u00a0which strengthen the possibility to\u00a0revoke or refuse a Market Authorisation based on environmental concerns and where\u00a0the\u00a0ERA is to cover the full lifecycle of a medicine including manufacturing and opens doors to use EMA quality inspectors to enforce environmental standards in manufacturing outside of the EU.\u201d<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

EFPIA response to the European Parliament Plenary vote<\/p>\n","protected":false},"author":12,"featured_media":107206,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[464],"tags":[],"class_list":["post-108127","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-press-releases","entry"],"acf":[],"yoast_head":"\nThe Pharma-Legislation has a long way to go to restore Europe\u2019s competitive edge | SFEE<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.sfee.gr\/en\/the-pharma-legislation-has-a-long-way-to-go-to-restore-europes-competitive-edge\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The Pharma-Legislation has a 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