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Romania among EU countries providing free access to the fewest innovative medicines. How will HTA improve the situation

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© European Union, Source: EC - Audiovisual Service

Health Technology Assessment (HTA) is a complex process that measures the added value of new medical technology compared to existing technologies. The aim of this assessment is to ensure that patients have access to the best treatment available on the market while analyzing the costs to the patient and the impact on the organization of health systems in administering the treatment. HTA can be a very important tool for Romanian patients in terms of access to new medicines, as Romania is among the EU countries that offer the fewest innovative medicines free of charge to patients.

Medical technologies are, for example, medicines, medical equipment, and methods of diagnosis, treatment, rehabilitation, and prevention.

The authorities involved in HTA assess both the therapeutic effect of the drug, potential side effects, the extent to which it affects the quality of life and how it is administered compared to existing therapeutic alternatives, and the costs of including a new drug in reimbursement. It is therefore a multidisciplinary process that synthesizes medical, economic, organizational, social, and ethical information related to the use of medical technology in a systematic way.

The main purpose of HTA is to provide evidence-based information to policy makers so that they can formulate safe, effective, patient-centered health policies that deliver maximum results at minimum cost. The HTA is also used by national authorities to decide which technologies should be reimbursed nationally.

The EU wants to strengthen EU cooperation on health technology assessment (HTA). Thus, the European Commission launched a new initiative in 2018, which has reached the final stages of the adoption process after the compromise reached during the German Presidency of the EU Council. The final vote in the EU Council is expected in November, in the European Parliament in December, and publication in the Official Journal in January 2022.

There are 3 main areas:

  • Joint Clinical Assessment – clinical evaluation of medicines.
  • Joint Scientific Consultation – structured dialogue with drug manufacturers to adapt the design of clinical trials to have the best possible evaluation criteria.
  • Horizon scanning – prospective research to identify drugs that will enter the market in the next 2-3 years.

The actual implementation will take place in 3 phases:

  • Winter 2024- early 2025: oncology drugs and ATMPs (advanced therapies, cellular, gene, etc.).
  • Winter 2027- early 2028: orphan drugs.
  • Winter 2029- early 2030: all medicines.

The most important structure will also be the Coordination Group, in which Member States must nominate representatives with competence in the field of health technology assessment.

Access to medicines in Romania vs. Europe

The objective of rapid, equitable and sustainable access to treatment must be shared by all key actors in the Romanian healthcare system and recognise the delays in access for patients in Romania. Romania’s gap can only be closed if our country will be directly and actively involved at European level in the decision making process on the new regulations for Health Technology Assessment (HTA).

Romania among EU countries providing free access to the fewest innovative medicines for patients

Data from the “W.A.I.T. Study” 2020 (published in 2021) – how long patients wait to access innovative therapies” shows that in Europe patients can wait between 4 months and 2.5 years to access the same new medicines depending on the country, with Romania coming last in this ranking.

Countries in north-western Europe have much faster access to the latest drugs than their neighbours in southern and eastern Europe, with patients in some countries waiting more than seven years or more, according to the new research. Access is fastest in Germany, with an average of 120 days between marketing authorisation and availability in the country, while Romania ranks last, with an average of 883 days.

Out of 152 innovative medicines approved by the European Medicines Agency between 2016 and 2019, only 39 (1 out of 4) have been included on the list of compensated and free medicines in Romania by 1 January 2021.

Germany introduced 133 medicines for compensation, Italy 114, Slovenia 78, Bulgaria 57 and Hungary 55. Thus, the availability rate of the latest generation of medicines for Romanian patients in the compensation system is only 26%, while 74% of medicines are available neither in the compensated nor in the private system.

The main causes of delays are the waiting time before submitting the reimbursement dossier (waiting for other countries to decide on reimbursement), the bureaucratic process, a Health Technology Assessment (HTA) system that is restrictive towards innovation, and an understaffed team that has a hard and arduous time dealing with dossiers submitted by pharmaceutical companies.

In terms of therapeutic areas, although access to oncology medicines appears to be improving, access to orphan drugs continues to vary considerably between EU Member States, with long delays and low availability in Central and Eastern Europe.

Read also: Romania has one of the worst performances in the EU when it comes to access to treatments for rare diseases

According to the CRA‘s „Report on root causes of market access delays”, there are 10 interrelated factors that explain the lack of medicines in local markets and access delays.

For Romania, the 3 main factors negatively influencing access are :

  1. Failure to meet deadlines for assessment and lack of predictability in updating the list of compensated medicines.
  2. Lack of multi-annual budget projections and insufficient budget for innovative medicines.
  3. Dysfunctions related to the procurement process of medicines in hospitals.

Strengthening EU cooperation on ETM after 2021

The new EU regulation establishes a working method, an implementation timetable, and decision-making structures for evaluations at the EU level. Evaluation reports will have to be taken into account in national processes, but the extent to which this is done is left to the Member States.

Implementation of the evaluation process is expected to start in winter 2024, with the evaluation of cancer drugs and advanced therapies (gene, cellular, etc). It is very important for Romania to define its position regarding the adoption of the European reports, to prepare its representatives for the working groups, and to analyze what and how much of the national legislation will be amended so that Romanian patients can benefit from innovative medicines as soon as possible.

Read also: Romania to negotiate for the first time, at European level, new regulations on patient access to treatments for rare and pediatric diseases

Diana Zaim este foto jurnalist, câștigătoare a Premiul Publicului la European Youth Event 2020, cel mai mare eveniment pentru tineri organizat de Parlamentul European. Absolventă a secției germană-portugheză în cadrul Universității din București, Diana urmează în prezent programul de master ”Relații Internaționale și Integrare Europeană” în cadrul SNSPA. Pasionată de promovarea valorilor europene, Diana este parte a comunității Model European Union, cea mai amplă simulare la nivel european a procesului decizional din cadrul Uniunii Europene.

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MEP Vasile Blaga: We cannot achieve the green economy goal without gas and nuclear energy as transitional fuels

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MEP Vasile Blaga (PNL, EPP) argues that the goal of a green economy cannot be achieved without gas and nuclear energy as transition fuels. He also said it isimportant for Romania to support the European Commission’s proposal to include gas and nuclear energy on the list of transitional fuels.

According to the MEP, Romania, both through the voice of President Iohannis and Prime Minister Nicolae Ciucă, has taken a position in favour of the European Commission’s proposal to include gas and nuclear energy on the list of transitional fuels.

“The context of the war in Ukraine, however, has given rise to voices in the European Parliament but also in other quarters who argue that the inclusion of gas in the delegated act would directly support Russia and its gas exports,” he added.

“It is an interpretation that creates a causal chain between two elements that are only circumstantially connected. The fact that gas is still considered a transition fuel to green energy does not mean that there is no gas other than that imported from Russia. Basically, the conflict in Ukraine is being used as an opportunity to reject a balanced and moderate vision of the transition to green energy”, said the Romanian MEP for www.caleaeuropeana.ro.

“Some colleagues who already had a position contrary to that of the Commission saw the conflict in Ukraine as an opportunity to argue. It is categorically false. We cannot achieve the goal of a green economy without gas and nuclear energy as transitional fuels. In any case, it is in Romania’s direct interest to support the European Commission’s proposal”, concluded MEP Vasile Blaga.

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MEP Vasile Blaga: Ukraine and Moldova will be part of the European family

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MEP Vasile Blaga (PNL, EPP) welcomes the fact that the Republic of Moldova and Ukraine have obtained the status of candidate states: “It represents the certainty that both will be members of the European Union, a huge step for the two candidate states, but also for the European Union.”

According to the MEP, the vote in the European Parliament and the decision in the Council say one thing: “the decisions are not symbolic gestures of consolation but certify that Ukraine and the Republic of Moldova will be part of the European family.”

He draws attention to the pro-Russian rhetoric that downplays the impact of these decisions: “To those who promote these ideas we say simply: the road of Ukraine and the Republic of Moldova is a one-way street. At the end of the road lies integration into the European Union. It is, of course, a road that will require sustained efforts on the part of both candidate countries, but also on the part of the EU institutions.”

“Romania has used all institutional means to ensure that the Republic of Moldova is not decoupled from Ukraine in this decision. It was vital that the two states were granted the status of candidates for EU membership as a package. This is an extraordinary outcome that is well worth mentioning”, he added.

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MEP Vasile Blaga supports a fair green transition for Romania: Gas and nuclear energy must be considered transitory

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© Vasile Blaga / Facebook

MEP Vasile Blaga (PNL, EPP) reaffirms his support for a fair green transition for Romania, in which gas and nuclear energy are accepted in order to achieve the objectives set by the European Ecological Pact.

The European Parliament hosted yesterday, 30 May, a public hearing whose guests were several experts who debated, together with members of the two committees ECON and ENVI, the inclusion of gas and nuclear energy in the taxonomy of the European Union. Many of the opinions expressed push the debate towards a rejection of the European Commission’s proposal of March whereby nuclear energy and gas are considered, under certain conditions, green.

I reaffirm my support for the version proposed by the European Commission. There are many reasons why gas and nuclear energy should be considered transitional in order to achieve the objectives set by the European Green Pact. One of the reasons, and perhaps the most important one, relates to the realities on the ground in each Member State. France has a significant share of nuclear power, just as Germany is heavily dependent on gas. The decisions that the European Union needs to implement in order to achieve the objectives – already set and agreed by all Member States – need to be balanced first and foremost”, EPP MEP Vasile Blaga told European Way.

“Countries like Romania or Poland need a realistic transition towards the targets set by the Green Pact. Cohesion and solidarity in the European Union means that each Member State must take into account the other and, as a whole, decisions must not ignore any reality, be it further West or further East”, added the EPP MEP.

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