That’s the quote from Iga Lipska, MD, PhD, MPH from the Medical College of Gdańsk, Medical Trials Middle 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 primary plenary was titled “The Convergence of HTA and Regulation: A New HTA Actuality and Collaboration with Regulatory Companies” The principle dialogue level was how Regulation (EU) 2021/2282 could be carried out in pratice. In response to the European Fee web site, the regulation goals to offer:

…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 will 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 many key themes of the panel had been round collaboration between regulatory consultants and HTA our bodies and sharing info. Nonetheless, there was woefully little when it comes to specifics of how this might be carried out in observe. Nonetheless, the HTAR regulation gives the potential for decreasing some duplicative HTA efforts whereas on the identical time permitting Member Nations to tailor worth evaluation, pricing and reimbursement to their very own nations wants. Whether or not or not we’ll attain a contented medium between centralized effectivity in proof analysis on the EU degree and decentralized decision-making, on the Member State degree, nonetheless, is but to be decided.

Wanting ahead to the remainder of the convention!