Asociace inovativního farmaceutického průmyslu/ Association of Innovative Pharmaceutical Industry
AIFP
Support of economic, professional and legal interests of the Association’s members; protection of rights and justified interests of the Association’s members; support of the pharmaceutical industry in Czech Republic.
ID: 988330547846-33
Lobbying Activity
Meeting with Alexandr Vondra (Member of the European Parliament)
18 Nov 2024 · EU Pharmaceutical Industry and Competitiveness
Response to Health technology assessment - Joint clinical assessments of medicinal products
2 Apr 2024
The EU HTA Regulation represents step-change in the assessment of clinical evidence of new technologies at EU level and has the potential to accelerate and improve access to patients as well as reduce inefficiencies and duplications, goals that the pharmaceutical industry shares. The EU HTA Reg. is reality and will start to affect HTA bodies, health technology developers and their technologies as well as patients and clinicians in less than 10 months time. The success of the EU HTA Reg. is contingent on the ability of the system to deliver high-quality JCA reports which provide added-value to national decision-makers. JCA process needs to: i. facilitate early engagement with the health technology developer (HTD), to ensure timely and optimally informed start of process and to enable the systematic exchange of relevant information with HTD. ii. to provide all participants with necessary information and evidence for scoping and assessment. iii. guarantee sufficient time for HTDs to conduct the relevant analyses required for preparing and finalizing their clinical evidence submission dossier. iv. allow assessors sufficient time to review the JCA dossier and to develop a high-quality JCA report. AIFP, an EFPIA member, is concerned about several glaring shortcoming in this draft JCA implementing act, especially regarding the workability of the JCA process, where it undermines the capacity of the HTD (from SMEs and biotech to larger pharmaceutical companies) to provide good quality submission to the assessors and co-assessors. Several reasons drive this concern: unbalanced time allocation between scoping and submission stages, the absence of visibility on submissions scope coupled with the expected size/complexity of the assessment scope driven from a mechanistic need to satisfy all needs of all MSs and the lack of meaningful participation of the HTDs at key steps of the process. AIFP together with EFPIA strongly believes that draft JCA implementing act can set the path towards successful EU JCA system if it recognizes the role key stakeholder in the process and enables rebalancing of workload in line with respective remits and obligations. This means that: The assessment scope should be finalized within 90 days of the start of the JCA procedure and the HTD should have at least 135 days to prepare a high-quality submission dossier. The HTD should have the opportunity to leverage all relevant information, evidence, and knowledge as key input into the definition of the assessment scope. The HTD should have an opportunity to meet and discuss with assessor/co-assessor its views on the draft assessment scope. The HTD should have visibility on the draft assessment scope proposed by the assessor/co-assessor as well as on the PICO survey responses from MSs (in an anonymized manner) at the earliest possible stage, to be able appropriate time to submit a high-quality submission response. These procedural changes are the minimum necessary to safeguard the future JCA system. AIFP together with EFPIA stands ready to meaningfully contribute to the success of the EU HTA Regulation for the benefit of EU patients. In the CZ the patients access to new innovative medicines has improved in last couple of years. The combined effort of all stakeholders (MoH, members of both chambers of the Parliament, State Institute of Drug Control, patients organizations, MAHs organized in trade organizations, etc.) resulted in creation of specific market access pathways for orphan medicinal products and for very innovative medicinal products. If one lesson has been learned, it is about the importance of co-operation among all stakeholders, including MAH. We believe that especially in the field of innovative medicines the appropriate inclusion of MAH into JCA as recommended by EFPIA can improve the HTA decision making process and ultimately bring the benefit of new treatment options assessed by JCA to patients in all EU MSs in shortest possible time.
Read full responseMeeting with Radka Maxová (Member of the European Parliament)
4 Jun 2021 · Legislativní návrhy