That is the quote from Iga Lipska, MD, PhD, MPH from the Medical University of Gdańsk, Clinical Trials Center in Warsaw, Poland. She was one the panelists on the ISPOR Europe Plenary speech. There have been a variety of good periods, lots of which I will likely be posting on all through the week.
The first plenary was titled “The Convergence of HTA and Regulation: A New HTA Reality and Collaboration with Regulatory Agencies” The important dialogue level was how Regulation (EU) 2021/2282 could be carried out in pratice. According to the European Commission web site, the regulation goals to supply:
…a clear and inclusive framework by establishing a Coordination Group of HTA nationwide or regional authorities, a stakeholder community and by laying down guidelines on the involvement in joint scientific assessments and joint scientific consultations of sufferers, scientific consultants and different related consultants.
The HTAR may even scale back duplication of efforts for nationwide HTA authorities and trade, facilitate enterprise predictability and make sure the long-term sustainability of EU HTA cooperation.
One of the important thing themes of the panel have been round collaboration between regulatory consultants and HTA our bodies and sharing data. However, there was woefully little by way of specifics of how this could be carried out in follow. Nevertheless, the HTAR regulation affords the potential for decreasing some duplicative HTA efforts whereas on the similar time permitting Member Nations to tailor worth evaluation, pricing and reimbursement to their very own international locations wants. Whether or not we’ll attain a cheerful medium between centralized effectivity in proof analysis on the EU stage and decentralized decision-making, on the Member State stage, nevertheless, is but to be decided.
Looking ahead to the remainder of the convention!