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Algemene vereniging van de Geneesmiddelenindustrie

pharma.be

pharma.be, de Algemene Vereniging van de Geneesmiddelenindustrie, groepeert 130+ farmaceutische ondernemingen met een vestiging in België.

Lobbying Activity

Response to Biotech Act

11 Jun 2025

Response of pharma.be to the Call for Evidence on the Biotech Act Pharma.be strongly supports the ambition to foster a world-class innovation environment for biotechnologies. To make the EU more attractive for researching, developing and manufacturing new technologies, simplify and safeguard a robust IP framework. Streamline Clinical Trials regulatory framework to attract clinical trials to EU: In the last 5 years, 60,000 EU patients missed out on a clinical trial (CT). In Belgium, we see a downward trend with newly authorised CT decreasing by 10% between 2022 and 2023. Approval timelines for CT in EU under the EU CT Regulation (CTR) are long compared to US and China (106 days standard vs 30 days in US and 60 days in China).The EU Biotech Act is an opportunity to create a more competitive, faster and streamlined regulatory framework to attract more clinical trials to the EU. This can be addressed by: reducing national requirements for CT applications, faster approvals and less administrative burden when obtaining approval for required changes to ongoing CTs (substantial modifications), Increasing the convergence of ethical reviews, exploit full potential of high-quality Real World data (RWD) to optimize the CT performance. Proposed action: modify article 2. (2).13 in the EU CTR and review articles 4, 6 (5), 6 (8), 8 (1) and 8 (2) (c) in the EU CTR. Embrace future-proof digital solutions: Future-proof digital solutions involves secure access to high-quality datasets to support innovation, integrating AI into life science R&D across the medicine lifecycle, and leveraging existing regulatory data to minimize duplication and administrative burdens. Aligning frameworks like the Data Act and TRIPS Agreement to protect sensitive information, fostering interoperability across Member States, leveraging EHDS and AI Act and enabling responsible data sharing will be key to unlocking transformative biotech innovation. Pause the implementation of the UWWTD: Pause the implementation of the Urban Waste-Water Treatment Directive (UWWTD) and amend it to address inconsistencies with the EU Polluter-Pay Principle and simplify its execution. Currently, only the pharmaceutical and cosmetic industries are selected to contribute financially to the clean-up of micropollutants, excluding other polluters such as industrial chemicals, pesticides, and household products. This situation significantly undermines the competitiveness of the pharmaceutical sector and increases the financial burden on manufacturers, ultimately preventing the valorization of innovation. Adding to the cumulative impact of other environmental policies, this burden undermines Europes strategic autonomy and fails to incentivize greener product development across all polluting sectors. Furthermore, the European Commissions Feasibility Study lacks adequate explanation regarding its conclusion that human medicines and cosmetic products account for 92% of pollution, and no clear methodology has been provided for excluding other micropollutants. Given the significant pharmaceutical manufacturing footprint of our country, we believe it is crucial that Pharma.be raises this point, advocating for a more balanced and inclusive framework. Reinforce internationally competitive Intellectual Property (IP) protection rules. Reforming the Supplementary Protection Certificate (SPC) framework to fully compensate innovators for time lost due to regulatory burdens and the pricing and reimbursement process; enhancing Regulatory Data Protection (RDP) protection for medicines for which patent protection is insufficient or unavailable; enacting a patent enforcement system with early resolution mechanisms to provide clarity for generic entry and treble damages for launches at risk. Predictable, strong and enforceable IP underpins a competitive EU, enhancing patients health and access to innovative medicines.
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Meeting with Maurice Whelan (Head of Unit Joint Research Centre), Tobias Wiesenthal (Head of Unit Joint Research Centre) and

4 Apr 2025 · Scientific roundtable discussion between the European Commission’s Joint Research Centre and the pharmaceutical industry on the topic of leveraging health data and data sciences for innovation

Meeting with Frédérique Ries (Member of the European Parliament, Shadow rapporteur)

14 Feb 2024 · Revision of the Pharmaceutical Legislation

Response to Evaluation and revision of the general pharmaceutical legislation

8 Nov 2023

pharma.be 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. Similarly, the introduction of TEV for antimicrobials is a step in the right direction, although improvements are needed to ensure it can deliver effectively. However, we are genuinely worried that measures within the legislation will accelerate the erosion of the EU innovative industry base, discouraging medicine R&D investment, jeopardising jobs and growth as well as negatively impacting patients access to the latest treatments. This matters acutely for Belgium. Our country has an international leading position in the biopharmaceutical sector, both in research & development and production. But at the same time, compared to other EU countries, Belgian patients are lagging behind when it comes to access to new innovative drugs. To secure todays position of Belgium as a Health and Biotech valley for tomorrow, a European environment that contributes to this is crucial. In that sense we share the serious concerns of EFPIA: 1. The proposal to shorten Regulatory Data Protection and Orphan Market Exclusivity, coupled with conditions that hinder innovators ability to recover incentives, will accelerate existing negative trends. The proposals are contrary to the EU Heads of State call (March 2023) for incentives to drive innovation to be strengthened, rather than reduced, to restore Europes competitiveness and meet the needs of patients. 2. To incentivise research efforts focused on meeting the needs of European patients, it is crucial to develop a patient-centered, more inclusive definition of unmet medical need. By encouraging incremental and breakthrough advances in prevention, treatment and care, Europe can ensure that no patient is left behind. 3. pharma.be applauds the achievements of the current OMP and Paediatric Regulations as European success stories. The proposed weakening of the OME regime will slow that progress, undermining the European orphan drug ecosystem and future investment in rare disease research. For paediatric medicines, the absence of a clear obligations framework in their development will hinder rather than support new developments in paediatric medicines in Europe. 4. pharma.be members are committed to reducing the potential impact of manufacturing, use and disposal of medicines on the environment. However, the possibility to refuse or restrict marketing authorisation solely on environmental grounds poses a significant threat to the established authorisation system and could delay or prevent patient access to life-saving medicines. This in a context where other overly strict chemicals and environmental policies are being developed that will drive manufacturing to other regions, undermining Europes strategic autonomy. 5. Policy solutions on addressing shortages should be proportionate to the risk, improve cooperation, and leverage digital technologies. Developing prevention plans for all medicines without a risk-based approach would strain resources for both industry and regulators. Similarly, earlier notification of shortages will have limited impact if the available data in the supply chain (EMVS, ECDC) is not effectively used to provide early visibility of shortage risks. pharma.be is committed to working with all stakeholders to close the competitiveness gap with other regions of the world, while taking action now to create faster, more equitable and sustainable access to medicines. Our industry is in a unique position to help create a healthier, more resilient and prosperous future for Belgium and Europe.
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Response to Evaluation and revision of the general pharmaceutical legislation

27 Apr 2021

Together with EFPIA, pharma.be supports an agile regulatory framework and a strong incentives’ system that embrace and encourage advances in science, technology and medicines. This evaluation is an opportunity to implement learnings from COVID-19 and ensure a competitive, world-class regulatory system in Europe supporting a globally competitive research-based industry at a critical time. Companies aim to bring products to as many patients as quickly as possible. However, the legislation cannot solve issues around access and affordability, which are national competences. We believe that a solid analysis of the current regulatory framework and root causes of unavailability and access delays is important and pharma.be is ready to engage in an open dialogue with relevant stakeholders to support this common goal. pharma.be reiterates EFPIA’s priorities for legislative change to equip the regulatory framework to respond quickly to patient needs: • Reinforce expertise-driven assessment and enable a more agile centralised authorisation framework by removing unnecessary interfaces between EC, EMA & Committees • Enhance expedited pathways framework supporting innovation • Expand the role of EMA in the assessment of drug-device/diagnostic combination products • Replace the paper patient information leaflets with electronic versions (cfr. e-PIL pilot project in BeLux) It will be crucial to enable future innovative approaches to medicines R&D eg by ensuring the acceptance of RWE in medicines evaluation both pre and post-authorisation and to further strengthen EU’s leadership towards global regulatory convergence especially as new technologies emerge. Revision of the Variations Regulation is a must to simplify and modernise the EU post-approval framework. Fast-paced developments in medicine, devices, data and digitalisation will lead to more personalised healthcare solutions. The legislation framework must set out the principles, whilst allowing for policy adaptations at a later point without the need for further legislative revision. Updates to existing policy and guidance documents can help to: • Encourage the use of novel clinical trial designs • Ensure ongoing scientific dialogue throughout product development • Enhance security, transparency and oversight of supply chains through a targeted stakeholder approach and incentives driven reforms based on facts. Pharma.be joins EFPIA’s calls for using the data stored in the interoperable network of national repositories (Falsified Medicines Directive) to provide additional intelligence in monitoring shortages • Support environmental risk assessments to cover product lifecycle and address sustainability The stability and predictability of the existing European incentives’ framework has enabled industry to invest in R&D and to deliver new medicines to patients, healthcare systems and society. For areas where there is a lack of a viable market (eg antimicrobials) and where the current framework has not yet covered all needs (eg OMP/Paediatrics), novel incentives adapted to the specific challenges of particular disease areas should be considered. Guided by science, pharma.be members are working both to address unmet need in diseases where there are no treatments and where the existing treatments do not sufficiently meet patient needs. To attract investment both in Europe and Belgium it is important that incentives are predictable and do not change late in development. However, linking incentives to access (national competence) could jeopardise the objectives of incentivising and improving access to innovation in the EU and Belgium. EFPIA produced a document describing the root causes of unavailability and delay. Several of the identified causes apply for Belgium. As these causes are interrelated, they can only be addressed by stakeholders working together and therefore pharma.be, together with EFPIA, continues to call for a High-Level Forum on Access to Health Innovation to address the
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Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

7 Jul 2020

The EU Pharmaceutical Strategy has the potential to support Europe’s medical research eco-system, enhance the region’s resilience to global health threats, address on-going health challenges as well as be a key driver for the EU’s economic recovery. Together with EFPIA, pharma.be welcomes the Commission’s recognition of the importance of the sector in the Roadmap and is committed to working with the EU and Member States towards a healthy future for patients in Europe, building on the lessons from the COVID-19 crisis. pharma.be reiterates EFPIA’s call for the necessary drivers of innovation to realise the EU’s ambition of supporting the industry in Europe to be a world leader in innovation and recover the ground lost to other regions of the world in medical innovation. Both Europe and Belgium need a research and manufacturing infrastructure that delivers the next generation of vaccines and treatments. Bringing health solutions to patients can be accelerated by a European framework that allows and encourages Member States to develop clinical trial networks, biobanks, data banks and data sharing policies, and innovative manufacturing. In addition, creating possibilities for an innovative supply chain and delivery tailored to the patient’s needs, and regulatory flexibility such as a move to electronic PIL, have the potential to ensure availability of medicines, even in times of pressure. Considering the importance of a knowledge economy for Belgium, pharma.be joins EFPIA’s call for a world-class IP framework to attract investment into the development of future treatments for the benefit of patients, including for patients with rare and paediatric diseases. Developing incentives to further address unmet medical needs and seize advances in science is critical to tackling issues like AMR and pandemic preparedness. SPC harmonisation and strong IP systems can increase certainty and predictability for innovators and investors alike. Europe needs a regulatory framework that is stable but adaptable, fast, effective and globally competitive. We need development support and regulatory approval times on par with other regions, EU regulators delivering world class scientific expertise in collaboration with global partners, simplification of the EU regulatory network, and connected regulatory oversight of drug-device/diagnostic combinations. We share the concern over inequalities of access to new treatments and vaccines across Europe. Also in Belgium, as the WAIT indicator points out, many medicines with a European marketing authorisation, are not available. EFPIA produced a document describing the root cause of unavailability and delay. Several of the identified causes apply for Belgium. As these causes are interrelated, they can only be addressed by stakeholders working together. By creating a High-Level Forum on Better Access to Health Innovation we can identify multi-stakeholder solutions for introducing new technologies that can broaden access, reduce delays and mitigate the impact of shortages. This collaborative dialogue must be evidence-based, requiring an EU-led analysis of the root causes and drivers of access, supply and shortage issues. EFPIA has proposed potential solutions utilising novel pricing and payment models, some of them already existing to some extent in Belgium, which could be more broadly implemented across European healthcare systems. By concluding the HTA Regulation negotiations we can address the misalignment on evidence between industry, regulators and HTA bodies. What is clear, is that access issues will not be addressed by tampering with the regulatory and incentives framework, integral to Europe’s ambition to be a world leader in medical innovation. pharma.be, together with EFPIA, stands ready to work with all stakeholders to create medical innovation and facilitate sustainable access for all.
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