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Romanian Association of International Medicines Manufacturers

ARPIM

The Romanian Association of International Drug Manufacturers (ARPIM) represents the innovative pharmaceutical industry operating in Romania.

Lobbying Activity

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

2 Apr 2024

ARPIM, the Romanian association representing 28 of the most important international innovative pharmaceutical manufacturers operating on the Romanian market, strongly supports the ambition of the EU JCA process, especially as it has the potential to provide an uniform assessment level and, therefore, help in reducing access delays, which in Romania are on average 918 days from the market authorization (MA) (for medicines with central MA in 2018-2021). The success of the EU HTA Regulation depends on the ability of the system to deliver timely, high-quality JCA reports, which bring value also to Romanian decision-makers. As such, the JCA process should: a) facilitate early engagement with the health technology developer (HTD), to ensure a timely and well-prepared start of the process and enable the systematic exchange of relevant information with the HTD b) provide participants with the necessary information and evidence for the scoping and assessment c) secure sufficient time for HTDs to conduct the relevant analyses for high-quality JCA submission dossiers d) ensure appropriate protection of commercially confidential information ARPIM is concerned about several provisions in the draft JCA implementing act, especially the limited involvement of the HTD in the scope process and the time discrepancy between scoping versus developing the submission file. This concern should be viewed also in the context where a inadequate-quality file would entail additional multiple requests at national level, in a Romanian system for which PICO is a novelty, who is also expecting a possible major change in its national HTA methodology and faces severe understaffing. As such, the proposals in the implementing act severely affect the capability of the HTD to provide a high-quality submission dossier. The lack of early visibility on the requirements also means that HTDs will not have enough time to prepare and deliver the full set of evidence expected by the JCA subgroup. This will negatively impact the final JCA output and its relevance and usability/uptake at national level. We call on the Commission to build on HTDs expertise to facilitate the definition of the most appropriate assessment scope (as is generally the case in regulatory and national HTA submissions). This would help rebalance the time dedicated to scoping and allow more time for content development and assessment. We believe that JCAs can be successful if the process builds on the on the strength of key stakeholders, establishes the procedural prerequisites and provides sufficient time for the HTD to develop timely a high-quality dossier. Our proposals, in line with those of EFPIA, are: -The HTD should have at least 135 days to prepare a high-quality submission dossier, achieved by reducing the time available to define the policy questions to 90 days. -The HTD should have the opportunity to contribute with all relevant information, evidence, and knowledge into the definition of the assessment scope at the time of the application for the marketing authorisation. -The HTD should have an opportunity to meet and discuss with the assessor/co-assessor its views on the consolidated assessment scope proposal. -The HTD should have visibility on the consolidated assessment scope proposed by the assessor/co-assessor at the earliest possible stage, to inform the development of a high-quality submission dossier. We also believe that the HTD should have access to individual Member States' input into the assessment scope, soon after the submission of the JCA dossier, in order to better prepare for national submission. These procedural changes are the most important ones for securing the workability of the future JCA system and its ability to result in timely and high quality JCA dossiers and consequently reports. For the benefit of the Romanian patients' faster access, we fully support EFPIA's proposals to improve the quality and timeliness of the process.
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Response to Evaluation and revision of the general pharmaceutical legislation

8 Nov 2023

ARPIM 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 have serious concerns 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: 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 and will not improve either access, nor affordability for countries like Romania. 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. ARPIM considers 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. The Bolar exemption expansion beyond marketing approval poses a threat to the enforcement of fully valid IP rights, further jeopardising EU competitiveness. Timely generic competition already exists. This expansion undermines the integrity of the IP system innovators rely on to continue their substantial investment in researching and developing novel therapies in Europe for European patients. 5. ARPIM 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. 6. 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. ARPIM is committed to a collaborative approach to address the competitiveness issue, 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 Europe.
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Response to Evaluation and revision of the general pharmaceutical legislation

8 Nov 2023

ARPIM 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 have serious concerns 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: 1. The proposal to shorten Regulatory Data Protection and Orphan Market Exclusivity, coupled with conditions that hinder innovators ability to recover incentives, will improve neither access, nor affordability for Romanian patients. 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. ARPIM considers 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. The Bolar exemption expansion beyond marketing approval poses a threat to the enforcement of fully valid IP rights, further jeopardising EU competitiveness. Timely generic competition already exists. This expansion undermines the integrity of the IP system innovators rely on to continue their substantial investment in researching and developing novel therapies in Europe for European patients. 5. ARPIM 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. 6. 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. ARPIM is committed to work collaboratively with all stakeholders for the benefit of Romanian patients as European patients, with the same rights of access to innovation and good-quality innovative medicines, while taking action now to create faster, more equitable and sustainable access to medicines.
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