IHSI’s role and HTA in the EU

Here is the clarification of IHSI’s role, its relationship to the EU institutions, and your obligations as a company.

1. What is IHSI? (The Legal Status)

• Not an EU Institution: The International Horizon Scanning Initiative (IHSI) is not an official agency of the European Union (like the EMA) nor a formal body of the EU HTA Regulation (like the HTACG).
• What it is: It is an independent, member-led non-profit organisation (AISBL based in Belgium). It was formed by a coalition of national payers and health ministries (originally the Beneluxa initiative) to pool resources for scanning the drug pipeline.
• Its Goal: To give national payers “early warning” of high-cost drugs so they can prepare budgets and negotiation strategies (e.g., “We know this drug is coming in 2 years, let’s start saving/planning”).

2. Is it mandatory to submit data to IHSI?

Strictly speaking: No.

• There is no legal obligation under EU law for a pharmaceutical company to proactively submit its MAA filing plans or data directly to IHSI.
• IHSI primarily builds its database by “scraping” public registries (ClinicalTrials.gov, EudraCT), purchasing commercial data (like IQVIA/GlobalData), and using AI tools. They do not rely solely on company submissions.

However, there is a “Shadow Mandate”:

While you don’t have to submit to IHSI, the EU HTA Coordination Group (HTACG)—which is the official EU body—explicitly uses IHSI reports to decide which drugs will undergo a mandatory Joint Clinical Assessment (JCA).

3. The “Official” Link: How IHSI informs the HTAR

This is where the confusion arises. The European Commission does not have its own internal horizon scanning team. Instead, they effectively “outsource” this intelligence gathering.

• The Workflow:
  1. EMA has a legal obligation to tell the HTA Coordination Group about submitted MAAs.
  2. IHSI (acting as a service provider/partner) scans for drugs before they reach the MAA stage (Phase 2/3).
  3. HTACG uses data from both EMA and IHSI to build the “List of Emerging Health Technologies.”
  4. Selection: Based on this list, the HTACG selects which products must undergo a JCA.

4. Strategic Advice: Should you engage with IHSI?

Even though it is not mandatory, most Market Access teams do engage with IHSI (or ensure their public registry data is spotless) for two reasons:

1. Accuracy for JCA Planning: If IHSI has incorrect data (e.g., they think your filing date is Jan 2026, but it’s actually Dec 2026), the EU HTA Coordination Group might schedule your JCA slot at the wrong time. This could cause administrative chaos for your launch. Correcting IHSI’s data helps ensure your JCA slot aligns with your actual regulatory reality.
2. Payer Perception: IHSI produces “High Impact Reports” for national pricing bodies (e.g., in Netherlands, Ireland, Belgium). If their report inaccurately estimates your patient population as “huge” or your budget impact as “massive” because of bad data, you start your pricing negotiations on the back foot.

Summary Table

	European Medicines Agency (EMA)	HTA Coordination Group (HTACG)	IHSI
Status	Official EU Agency	Official EU Governance Body	Independent Non-Profit / Vendor
Role	Regulatory Approval (Safety/Efficacy)	Joint Clinical Assessment (JCA)	Horizon Scanning (Data Provider)
Mandatory Submission?	YES (MAA)	YES (JCA Dossier)	NO (Voluntary / Strategic)
Relationship	Regulates the drug	Assesses the drug	Informs the assessor about the drug

Recommendation:

You do not need to send a formal “filing plan” to IHSI in the same way you do to the EMA. However, you should check if your product appears correctly in public registries, as this is where IHSI pulls its data. If IHSI contacts you for validation (often via their partner ECRI), it is usually strategically wise to cooperate to ensure the EU HTA bodies are planning based on accurate dates.