⁉️ Clear process, but no transparency on the individual selection 
 

🔊 On Dec 9th European Commission finally published 10 guidance documents for EU HTA. Even though publication of Implementing Acts attracted much more interest, the guidance documents are the fine print that will decide on the details. Today we will take a closer look at the Guidance on Appointment (G09). Officially it is called "Guidance on the appointment of assessors and co-assessors for Joint Clinical Assessment (JCA) and Joint Scientific Consultation (JSC)". 
 

✅ Here is how it works: 

🔹There are two relevant subgroups (SG) with similar rules for appointment: SG JSC and SG JCA. 

🔹Each subgroup consists of representatives, alternates and ad hoc representatives from each Member State. Assessor and co-assessor are selected out of these members (representatives, alternates) of a SG. Ad hoc representatives can assist and observe. 

🔹Assessor and co-assessor lead the scientific and technical tasks of the joint work on a specific product and prepare the respective outcome documents 

🔹Individual members need to apply for the role of assessor or co-assessor. 

🔹Each application is reviewed based on the following criteria: 

1️⃣ Potential conflicts of interest 

2️⃣ Previously active as assessor or co-assessor for JSC of this health technology 

3️⃣ Areas of expertise

 

Areas of expertise are:

🔎 HTA expertise, including health economics (for JSC only) 

🩺 Expertise in therapeutic area 

💊 Expertise in relevant technology 

🖥️ Information specialist 

📊 Statistical expertise

 

In case more than one applicant meets the requirements, the SG will choose, based on expertise, previous HTA experience at EU level and geographical spread. 

 

Makes sense. 

❌ What is missing is any form of transparency on the selection process.