There is no denying that the beginning of 2025 promises to be a dynamic year in terms of regulatory changes relevant to the life sciences and healthcare industry, for the European Union as a whole, but also for Poland in particular.

For example, the early calendar of legislative changes that took effect this January is promising:

  • 31 January 2025 marked the introduction of mandatory use of the CTIS – Clinical Trials Information System database across the clinical trials industry,
  • new legislation relevant to the medical device industry came into effect on 10 January 2025 with the entry into force of amendments to the MDR and IVDR regulations,
  • 12 January 2025 was a particularly important date for the broad market of medical technology players – the start of the new health technology assessment regulations and thus the start of the actual entry into force of the so-called ‘joint clinical assessment’ of health technologies.

The following is a brief summary of the challenges, but also opportunities, that the medical technology market, and in particular the pharmaceutical industry, in the EU and in Poland brought in early 2025.

What are the current rules for HTA at a national level?

Currently, as a general rule – health technology assessment takes place at a national level. In general it means that a company wishing to market a new product that will qualify as a health technology, must obtain the appropriate approval in each of the EU Member States in which they wish to introduce such a product. In Poland, so far the body in charge of the health technology assessment process is the Agency for Health Technology Assessment and Tariff System (PL: Agencja Oceny Technologii Medycznych i Taryfikacji; “AOTMiT”).

The implications of HTA results are directly relevant to medicines in terms of national reimbursement applications and patient access to innovative therapies.

It should be noted, however, that the date of the 12 January 2025 does not immediately change the rules for the entire pharmaceutical, medical devices and healthcare market at once in EU and Poland, but at the beginning will initially cover a selected group of pharma products – new medicines for the treatment of cancer and advanced therapy medicinal products – ATMPs.

Regulation 2021/2282 (“HTA Regulation”) – what HTA Regulation brings to the health technology assessment?

With the beginning of 2025, the first phase of the already three-year-long implementation process of the new health technology assessment system, which is to be common to all EU countries, partially came to an end.

First, the question should be answered: what is health technology assessment? According to the legal definition – HTA means a multidisciplinary process that summarises information about the medical, patient and social aspects and the economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased and robust manner.

Which medical technology categories are addressed first by new HTA rules in practice?

However, the new rules will not apply immediately to all medical technologies. In practice, the legislation will initially require the new rules to be applied only to selected product groups, i.e.:

  • medicinal products – but initially limited to those containing a new active substance for which the therapeutic indication is the treatment of cancer – and
  • advanced therapy medicinal products – ATMPs – under the umbrella of ATMPs, there are three main groups of products used for therapies that are becoming increasingly important in the pharmaceutical and healthcare markets in general, namely:
    • gene therapy medicinal products – GTMPs;
    • somatic cell therapy medicinal products – sCTMP;
    • tissue-engineered products – TEP.

The two categories of products that are the first to be subject to HTA regulation in practice will therefore initially be medicines that are, in principle, registered under the European Medicine Agency’s centralized marketing authorization procedure.

It is also worth noting that in Poland, ATMPs may also be used in justified cases (after prior approval by the relevant regulatory authorities) with the possibility for the patient to obtain early access to therapy under the ATMP Hospital Exemption scheme – ATMP-HE, a procedure which allows the patient to obtain access to a medicinal product individually prescribed for a specific patient within the framework of personalized therapy with a product from the ATMP category.

Over the coming years, the new HTA rules are expected to cover other medical technologies: orphan drugs in 2028, and in 2030 the final step is to cover all medicines.

Selected medical devices will be subject to the HTA Regulation on a slightly different basis and timing to medicines.

What will the new HTA criteria be?

According to the new EU law – the health technology assessments will be divided into two main parts:

  • joint clinical assessment (4 clinical domains)
    • the identification of a health problem and a current health technology,
    • the examination of the technical characteristics of the health technology being assessed,
    • relative safety,
    • relative clinical effectiveness;
  • non-clinical assessment (5 non-clinical domains)
    • the cost and economic evaluation of a health technology, and its
    • ethical,
    • organizational,
    • social,
    • legal aspects.

New HTA Regulation in Poland – current legislative works

In Poland, HTA regulations are mainly to be found in the laws shaping the reimbursement market and on health benefits. Legislative work is currently under way in Poland to adapt local regulations to the change in EU law.

The changes currently under way in Poland are not significant and are mainly aimed at aligning the nomenclature of Polish laws with the HTA Regulation.

Summary of the prospects and objectives of the new rules for HTA from 2025

The aim of the HTA Regulation and its amendments is to make it easier for medical companies, working in the general pharma, medical devices and healthcare market, to obtain assessments of new health technologies so that the rules for their introduction into the common market are transparent and the same for all countries and entrepreneurs operating in the EU.

Importantly, the new HTA Regulation should, as a primary objective and as a consequence, lead to improvements in the process of access to new medical technologies for patients in the EU.

Footnote:

Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU

Regulation (EC) No. 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No. 726/2004

Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

Polish Act of 6 September 2001 Pharmaceutical Law

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