Market Access & Health Technology Assesment: Romania

Join industry executives in staying informed on the market access and HTA process in Romania. 

1. Please make a general introduction to the public health sector in your country and its organization

The Romanian social health insurance system is coordinated at a central level by the Ministry of Health, the National Insurance House and the National Agency of Medicines and Medical Devices. Each of these authorities have specific competences in connection with the marketing authorization, the pricing and the reimbursement of medicinal products, medical devices and healthcare services.

At the level of each county, the Ministry of Health is represented by a local public health department which supervises the activities carried out by the entities performing medical services and have other attribution in connection with the authorisation and coordination of the providers in the healthcare systems.

The National Insurance House set up a local county health insurance in each of the 41 counties of Romania, one local county health insurance for the Bucharest Municipality, as well as a separate insurance house for the insured individuals belonging to the military personnel, police and magistrates professions.

These local health insurance houses conclude agreements with the providers of medicinal products, of medical devices as well as with the providers of medical services (e.g. hospitals, medical centers and clinics). Based on these agreements, the providers will supply medicines or, as the case may be, medicinal products, or they may provide medical services to the insured individuals, free of charge or at a reduced price.

The value reimbursed by the Romanian state for the respective medicinal products, medical devices or medical services will be subsequently paid by the local Health Insurance House to the respective providers based on the supporting documentation submitted by these providers on a monthly basis.

In order to be reimbursed in the National Insurance System, a medicinal product needs to go through certain procedural steps, starting with the issuance of a marketing authorisation valid for Romania and ending with its inclusion in the list of reimbursement medicines.

The central authorities mentioned at the beginning of this section have specific attributions in connection with this proces. As a rule, the marketing authorisation holder should appoint one or more local representatives, who will represent it before each competent authority.

As a rule, each procedure (e.g. marketing authorisation, price approval, HTA, reimbursement) is separate and should be handled by filing an application dossier with the competent authority. Certain steps can be performed only after the completion of other procedures (e.g., in order to apply for reimbursement, the medicines’s price has to be approved by the Ministry of Health).

Also from this Market Access & Health Technology Assessment

Join industry executives in staying informed on the market access and HTA process in Romania. 

1. Which are the administrations, bodies and institutions in charge of public health in your country and what are their respective responsibilities?

The main administrations, bodies and institutions in charge of public health in Romania are:

1. The Ministry of Health: the central authority in the health field, functioning under the subordination of the Romanian Government; the Ministry of Health has the following main competences in connection with the public health:

• elaborates policies, strategies and action programs in connection with the population’s health, in accordance with the Government’s programs, coordinates and controls the implementation of policies, strategies and programs in the public health field, at national, regional and local level;
• evaluates and monitors the health status of the population, takes measures to improve it and informs the Government on health indicators, evolution tendencies and necessary measures to improve them;
• regulates the organization and functioning of the national health system;
• elaborates, implements and coordinates national health programs, in order to achieve the objectives of the public health policy.

2. The county Public Health Departments, under the subordination of the Ministry of Health; these Public Health Departments:

• operate at the level of the 41 counties of Romania and of the municipality of Bucharest;
• have legal personality and function under the subordination of the Ministry of Health, in accordance with the applicable legislation;

The organization and functioning regulation of the public health departments, as well as the specific conditions for the public management functions in the public health departments are approved by order of the Ministry of Health.

3. The National Institute of Public Health: a specialized body of the central public administration in the field of public health, subordinated to the Ministry of Health. The National Institute of Public Health has the following main attributions:

• ensures the technical and methodological guidance of the public health network through its national and regional structures;
• participates in the elaboration of strategies and policies in the field of public health;
• drafts laws, norms, methodologies and instructions on specific topics related to the public health;
• supervises the health of the population, the transmissible and non-transmissible diseases, to identify the common health issues;
• provides the system of epidemiological supervision, as well as early alert and rapid response and participates in the exchange of information within the European Epidemiological Supervisory Network in the field of transmissible diseases;
• elaborates the methodology, tools and indicators of monitoring and evaluation of services and programs of public health, health promotion and health education;
• carries out research and development activities in the field of public health and sanitary management.

4. The specialized commissions, sub-commissions and multidisciplinary commissions within the Ministry of Health, which provide the necessary expertise on the basis of which the Ministry of Health coordinates, from a scientific, professional and methodological point of view, the medical assistance network. The specialized commissions of the Ministry of Health have a very important role in the issuance of the therapeutic protocols for the prescription of medicines.

2. Which are the administrations, bodies and institutions in charge of drug approvals in your country and what are their respective responsibilities?

The National Agency for Medicines and Medical Devices (the “NAMMD”) is the main regulatory authority in Romania in the pharmaceutical field and it is in charge with medicinal products’ approvals. NAMMD is subordinated to the Ministry of Health.

Amongst the main competences of NAMMD, the following should be noted:

• the drafting of various norms, guidelines and regulations in connection with medicinal products;
• the issuance of the marketing authorization for medicinal products, under the national procedure and under the mutual recognition/ decentralized procedure;
• the control of the quality of medicinal products as regards the manufacturing process, the import, the wholesale and retail distribution;
• the issuance of the wholesale distribution authorisation and manufacturing and import authorization;
• the regulation and control of the pharmacovigilance activities.

3. Which are the administrations, bodies and institutions in charge of Health Technology Assessment in your countries and what are their respective responsibilities?

NAMMD is the competent national authority in the health technology assessment (“HTA”) field and has the following main attributions:

• elaborates and reviews the national methodology and the HTA criteria, as well as the form of the medical technologies evaluation HTA reports, in accordance with the international standards;
• analyzes and evaluates the reports drafted by authorized institutions, organizations, experts or external researchers, regarding the HTA, for objectivity, validity, compliance and scientific rigor;
• collaborates with professional bodies in the health system and academic institutions for HTA purposes;
• collects and analyzes the statistical data relevant for the HTA from all institutions of the health system;
• assesses the documentation based on the HTA mechanism and it issues the decision regarding the inclusion, extension of indications, non-inclusion or exclusion of medicines in/from the list of reimbursed medicines (i.e., the list comprising the international non-proprietary names corresponding to the medicines the insured persons benefit of, with or without personal contribution, based on medical prescription, in the social health insurance system, as well as the international non-proprietary names corresponding to the medicines that are released within the national health programs (the “INN Reimbursement List”));
• may requests the specialized commissions of the Ministry of Health to draft the relevant therapeutic protocols for the medicines’ prescription;
• analyzes and approves the therapeutic protocols elaborated and/or amended by the specialized commissions of the Ministry of Health.

NAMMD has a special department which handles HTA matters, namely, the HTA Department.

4. Which are the administrations, bodies and institutions that qualify as “payers” in your country and what are their respective responsibilities?

The Romanian health insurance system is based on mandatory public health insurance and is co-ordinated at national level by the National Health Insurance House (the “NHIH”), which has under its subordination 42 local/county public health insurance houses and a special health insurance house, namely, the OPSNAJ health insurance house.

The “payers” in Romania are, as follows:

1.the NHIH, which is an autonomous public institution which manages the social health insurance system in accordance with the Government’s policies and programs in the sanitary field, having, inter alia, the following main competences:

• proposing, with the prior notice of the Ministry of Health, legislative measures for ensuring the proper functioning of the health insurance system;
• approving the regulations on the collection, management and control of the social health insurance fund;
• drawing up and updating of the registries of insured patients;
• guiding and monitoring the enforcement of the regulatory provisions by the local health insurance houses;
• drafting the national framework agreement regarding the provision of medical assistance in the social health insurance system;
• elaborating forecasts, strategies, studies and analyses on the development and functioning of the health insurance system in Romania, with the aim of further improving it;
• monitoring the reimbursement of medicinal products;
• preparing the lists of medicinal products (trade names) reimbursed within the social health insurance system, in line with the health technology assessments made by NAMMD and the Government’s decisions.

2. the local/county public health insurance houses and the OPSNAJ health insurance house, which:

• conclude supply (reimbursement) agreements with the suppliers of medical services (pharmacies, hospitals and dialysis centers);
• receive suppliers of medical services reimbursement data and information on medicines’ consumption and report to the NHIH such data and information;
• pay the reimbursement amounts to the suppliers of medical services.

5. Which are the administrations, bodies and institutions in charge of pricing decisions in your country and what are their respective responsibilities?

The Ministry of Health is the Romanian competent authority in pricing matters and it has the following main attributions:

• approves the prices of medicinal products released based on medical prescription (Rx medicines);
• approves the prices of certain over-the-counter medicinal products (OTC medicines) prescribed to patients in the social health insurance system;
• approves the reimbursement prices of medicines in the national health insurance house and in the national health programs;
• drafts and updates the national medicines price catalogues, namely the National Catalogue of the Prices of Medicinal Products Authorised for Marketing in Romania (CANAMED) and the National Public Catalogue;
• establishes the rules of approving the price of medicines to ensure the use of public resources in a cost/efficient manner.

The Ministry of Health has a special department handling pricing matters, namely the Directorate of Medicines and Medical Devices Policy.

6. Which are the administrations, bodies and institutions in charge of reimbursement decisions in your countries and what are their respective responsibilities?

The authorities in charge of the reimbursement of medicinal products in Romania are as follows:

• NAMMD, which performs the health technology assessment (HTA) and issues the decisions regarding the inclusion of medicinal products in the reimbursement list (i.e. the conditional or unconditional inclusion, extension of indications, non-inclusion or exclusion of medicines in/from the INN Reimbursement List);
• the Romanian Government, which approves and amends the INN Reimbursement List, by means of a Government decision, based on the Ministry of Health’s and NAMMD’s proposal;
• NHIH, which concludes cost-volume agreements and cost-volume-result agreements with the marketing authorisation holders/their legal representatives for the reimbursement of certain medicinal products.

NHIH and the Ministry of Health approve the final lists of medicinal products reimbursed in the social health insurance system and in the national health programs, providing for the trade names and reimbursement prices, referred to as the “Trade Names Reimbursement Lists”.

7. Which are the administrations, bodies and institutions in charge of public procurement and tendering in your country and what are their respective responsibilities?

The administrations, bodies and institutions in charge of public procurement and tendering for medicinal products in Romania are:

At centralized/national level:

• the Ministry of Health, which organizes national tenders for the acquisition of medicinal products and should conclude framework agreements on behalf and for the public health units within the Ministry of Health’s and the local public administration authorities’ structure (g., for public hospitals).

The list of the medicines acquired by the Ministry of Health at centralized level should be updated every year.

In principle, for the acquisition of the relevant medicines the Ministry of Health should organize a public tender procedure where any interested party could participate.

• UNIFARM, a company under the Ministry of Health’s subordination, whose main business object is supplying the healthcare system with medicines, vaccines and other products originating from both the national production and import/ EU intracommunity trade.

UNIFARM cooperates with the Ministry of Health for the implementation of the national health programs organized and financed by the Ministry, pursuant to the Health Law, and has different responsibilities in relation to the acquisition of medicines in Romania.

• the National Office for Centralized Acquisitions (the “NOCA”), a public institution with legal personality, subordinated to the Ministry of Finance, which was set up in 2018 and is entirely financed from the state budget through the budget of the Ministry of Finance;

At local level: the hospitals, which are the main contracting authorities (public partners) and, inter alia:

• launch public tenders based on the needs of medicines reported by healthcare professionals (HCPs);
• under certain conditions, can purchase medicines under a direct acquisition procedure;
• set the necessary documentation for the performance of the public tender procedure, including the aspects relevant for the negotiation and conclusion of agreements.

8. What are the other actors of significance with regards to market access in your country and what are their respective responsibilities?

The main authorities relevant from a market access perspective are:

• the Romanian Government, which oversees the activities of the central health authorities and has specific attributions in the pharma field, including the approval of the INN reimbursement list and the approval of the national health programs;
• the National Agency for Medicines and Medical Devices (NAMMD), which is the main regulatory authority that:
  • issues marketing authorisations for medicinal products;
  • grants wholesale distribution authorisations, as well as manufacturing and import licences;
  • authorises clinical trials;
  • performs health technology assessments for medicines and issues the decision for the inclusion of the medicine on the INN Reimbursement List.
• the Ministry of Health (including its specialized commissions and sub-commissions), which issues policies, strategies and regulations in the pharma field, and has, among others, powers to:
  • approve the maximum prices of medicinal products applicable in Romania;
  • regulate the reimbursement of medicines in the national health system and in the national health programs.
• the National Health Insurance House, which manages the social health insurance system, concludes managed entry agreements for the access to treatment (e.g. cost volume and cost volume result agreements) and has extensive powers in relation to the reimbursement of medicinal products in the national health system and in the national health programs.

Also from this Market Access & Health Technology Assessment

Join industry executives in staying informed on the market access and HTA process in Romania. 

1. What are the pricing models, processes and principles for originator drugs?

The main enactment setting out the pricing models and approval procedures for medicines is Ministry of Health’s Order no. 368/2017 approving the Norms regarding the calculation method and the approval procedure of the maximum prices of medicinal products for human use, providing that:

• the Ministry of Health is the competent authority to approve the price of medicinal products released based on medical prescription (Rx medicines) and over-the-counter medicinal products (OTC medicines) prescribed to patients in the social health insurance system; in the case of other OTC medicines, the price can be freely determined and modified by their marketing authorization holders;
• in order to obtain the price approval, the medicine’s marketing authorization holder should submit an application dossier to the Ministry of Health, including, among other documents, a standard application form and a comparison with the maximum manufacturer price of the same product, authorized in the following 12 reference countries: Czech Republic, Bulgaria, Hungary, Poland, Slovakia, Austria, Belgium, Italy, Lithuania, Spain, Greece and Germany;
• as a rule, the maximum manufacturer price proposed by the marketing authorization holder for the CANAMED catalogue in Romania should be lower than or (at most) equal to the lowest price of the same medicinal product in the 12 comparison countries;
• by way of exception, the price of certain medicines (e.g., immunologic medicines and of medicines derived from blood or human plasma) should be lower than or (at most) equal to the average of the lowest 3 (three) prices of the same product in the 12 comparison countries. If the medicine has a price approved in only one of the 12 comparison countries, the price proposed for Romania should be lower than or (at most) equal to the price in the respective country. If there is no price approved in any of the 12 comparison countries, the price for Romania could be approved at the level proposed by the marketing authorization holder or its representative;
• the prices of medicinal products (including the manufacturer price, as well as the maximum wholesale and retail prices) should be approved within 90 days, and should be published by the Ministry of Health in an order approving the price catalogue.

2. What are the pricing models, processes and principles for generics and biosimilars drugs?

According to the Ministry of Health’s Order no. 368/2017 approving the Norms regarding the calculation method and the approval procedure of the maximum prices of medicinal products for human use:

• in order to obtain the price approval for generic and/or biosimilar medicines, the medicine’s marketing authorization holder should submit an application dossier to the Ministry of Health, including, among other documents, a standard application form and a comparison with the maximum manufacturer price of the same product, authorized in the following 12 reference countries: Czech Republic, Bulgaria, Hungary, Poland, Slovakia, Austria, Belgium, Italy, Lithuania, Spain, Greece and Germany;
• the price of generic medicinal products should be lower than or (at most) equal to the generic reference price (65% of the price of the reference innovative medicinal product), while the price of biosimilars should be lower than or (at most) equal to the biosimilar reference price ( 80% of the price of the reference biological medicine);
• in case the reference innovative/biological medicine does not have an approved price, the generic/biosimilar reference price should be established by the 12-country comparison rule and the 65% / 80% referencing rule would not apply;
• the prices of medicinal products (including the manufacturer price, as well as the maximum wholesale and retail prices) should be approved within 90 days, and should be published by the Ministry of Health in an order approving the price catalogue.

3. What are the reimbursement approval processes and principles for originator drugs?

In order to determine if a medicinal product could be included in the list of the international non-proprietary names (“INN Reimbursement List”), the NAMMD performs a health technology assessment (“HTA”), by taking into account, amongst others, the cost of the therapy (including the price approved by the Ministry of Health) and the HTA reports issued by other competent authorities, such as the HTA agencies from France, Great Britain and Germany.

The HTA report should conclude if the INN meets the criteria and the score for being included unconditionally or conditionally in the INN Reimbursement List, following which NAMMD issues a decision accordingly.

The inclusion in the INN Reimbursement List is approved by the Romanian Government, after the HTA evaluation, by government decision. The medicinal products are included in the relevant sub-list (A, B, C1, C2, C3 or D) of the INN Reimbursement List depending on the level of their reimbursement set by the competent authorities (e.g., 20%, 50%, 90% or 100% of the reimbursement price).

Following the inclusion of the product’s INN in the INN Reimbursement List, NHIH and, in certain cases, NHIH jointly with the Ministry of Health performs the inclusion of the medicinal product in the Trade Names Reimbursement List(s). Such list mentions the reimbursement prices of the medicines granted in the health insurance system and in the national health programs;

Once a medicinal product is included in the Trade Names Reimbursement List, it could be acquired by the insured patients at a reduced price or free of charge, depending on the medicine’s price and the value which is reimbursed according to the applicable regulations (i.e., its reimbursement price).

4. What are the reimbursement approval processes and principles for generics and biosimilar drugs?

The reimbursement approval process for generics and biosimilars is similar to the process for innovative medicines.

Thus, in order to determine if a medicinal product could be included in the list of the international non-proprietary names (“INN Reimbursement List”), the NAMMD performs a health technology assessment (“HTA”), by taking into account, amongst others, the cost of the therapy (including the price approved by the Ministry of Health) and the HTA reports issued by other competent authorities, such as the HTA agencies from France, Great Britain and Germany.

Compared to innovative medicines, the HTA evaluation for generic/biosimilar medicinal products could be performed by NAMMD over a shorter period of time.

Following the inclusion of the product’s INN in the INN Reimbursement List based on a Government Decision, NHIH and, in certain cases, NHIH jointly with the Ministry of Health performs the inclusion of the medicinal product in the Trade Names Reimbursement List(s). The medicines included in the respective list(s) could be acquired by the insured patients from pharmacies at a reduced price or free of charge, depending on the medicine’s price and the value which is reimbursed according to the applicable regulations.

5. Are there any other special processes to be considered for certain types of drugs?

N/A

Also from this Market Access & Health Technology Assessment

Join industry executives in staying informed on the market access and HTA process in Romania. 

1. Price Control

1.1. How does price control at ex-factory prices work in your country?

In order to obtain the maximum manufacturer price approval, the medicine’s marketing authorization holder should submit an application dossier to the Ministry of Health, including, among other documents, a standard application form and a comparison with the maximum manufacturer price of the same product, authorized in the following 12 reference countries: Czech Republic, Bulgaria, Hungary, Poland, Slovakia, Austria, Belgium, Italy, Lithuania, Spain, Greece and Germany.

The National Catalogue of the Prices of Medicinal Products Authorised for Marketing in Romania (CANAMED) sets out the maximum prices of medicinal products of human use available in Romania, which may be used/traded by the marketing authorization holders or their representatives, wholesale distributors and providers of medical services or medicines for those medicinal products which are subject to a contractual relationship with the Ministry of Health, the health insurance houses and/or with the public health departments;

The National Public Catalogue sets out the maximum prices of medicinal products for human use available in Romania, which may be used/traded exclusively by community pharmacies/local distribution offices/closed-circuit pharmacies and drugstores which are not in a contractual relationship with the health insurance houses and/or with the public health departments and/or the Ministry of Health.

The general rule is that the maximum manufacturer price (i.e., the CIP price (Carriage and Insurance Paid to) according to the INCOTERM rules)) proposed by the marketing authorisation holder for a medicine, for the CANAMED catalogue, should be lower than or (at most) equal to the lowest price of the same medicine in the 12 reference countries.

By way of exception, the CANAMED price of certain medicines (e.g., immunologic medicines and of medicines derived from blood or human plasma) should be lower than or (at most) equal to the average of the lowest 3 (three) prices of the same product in the 12 comparison countries.

If the medicine has a price approved in only one of the 12 comparison countries, the price proposed for Romania should be lower than or (at most) equal to the price in the respective country. If there is no price approved in any of the 12 comparison countries, the price for Romania could be approved at the level proposed by the marketing authorization holder or its representative.

In case of the Public Catalogue, the manufacturer price should be lower than or (at most) equal to the average of the lowest 3 (three) prices of the same product in the 12 comparison countries.

1.2. How does price control at the wholesale level work in your country?

Pursuant to the Pricing Norms, the Ministry of Health approves two price catalogues, namely the CANAMED and the Public Catalogue, and each of them will mention the maximum wholesale prices (exclusive of VAT), together with the maximum manufacturer prices and the maximum retail prices (with VAT) for the medicines traded on the Romanian market.

The maximum wholesaler margin, as well as the máximum wholesaler price of each medicine, are approved according to the law and should not be exceded.

3. How does price control at the retail pharmacy level work in your country?

Pursuant to the Pricing Norms, the Ministry of Health approves two price catalogues, namely the CANAMED and the Public Catalogue, and each of them will mention the maximum retail prices (with VAT), as well as the maximum manufacturer prices and the maximum wholesale prices (exclusive of VAT), for the medicines traded on the Romanian market.

The maximum pharmacy margin, as well as the maximum pharmacy price of each medicine, are approved according to the law and should not be exceded.

2. External Reference Pricing (ERP)

2.1. Is there a system of external reference pricing (ERP) in place in your country?

Yes, the price proposed by a marketing authorisation holder or its representative for Romania should be approved by the Ministry of Health. Upon submission of the application dossier to the Ministry of Health, in order to obtain the maximum price approval, the medicine’s marketing authorization holder should submit, among other documents, a comparison with the maximum manufacturer price of the same product, authorized in the following 12 reference countries: Czech Republic, Bulgaria, Hungary, Poland, Slovakia, Austria, Belgium, Italy, Lithuania, Spain, Greece and Germany.

2.2. When and/or how often is ERP activated?

The Ministry of Health carries out an annual price correction procedure of the maximum prices listed in CANAMED and in the Public Catalogue, where the marketing authorisation holder or its representative for Romania should submit updated information regarding the prices approved in the 12 reference countries.

2.3. What is the legal framework of the ERP in place in your country?

The main enactment setting out the ERP system in Romania is the Ministry of Health’s Order no. 368/2017 approving the Norms regarding the calculation method and the approval procedure of the maximum prices of medicinal products for human use (the Pricing Norms).

2.4. What is the composition of the country basket? 

The ERP system in Romania involves a comparison with the maximum manufacturer price of the same medicinal product, authorized in the following 12 reference countries: Czech Republic, Bulgaria, Hungary, Poland, Slovakia, Austria, Belgium, Italy, Lithuania, Spain, Greece and Germany.

2.5. Describe the price calculation and selection for reference products.

The approved prices of medicinal products (i.e., the manufacturer price and the maximum wholesale and retail prices) are published in the Public Catalogue and in CANAMED.

Please see above.

2.6. How often does the price need to be updated?

As a rule, the price is valid for 1 (one) year, and the Ministry of Health should carriy out an annual price correction procedure of the maximum prices listed in CANAMED and in the Public Catalogue.

Please see above.

2.7. How do the “price List”/catalogues from references countries work in your country?

The links to the source catalogues providing the maximum manufacturer price in the 12 reference countries are published on a special internet platform, which should be used when submitting the pricing applications electronically with the Ministry of Health.

3. Internal Reference Pricing (IRP) (Note, this is not applicable in some market, develop if is applicable to your country)

N/A

Also from this Market Access & Health Technology Assessment

Join industry executives in staying informed on the market access and HTA process in Romania. 

1. Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country? 

The National Agency for Medicines and Medical Devices (NAMMD) is the main authority that performs health technology assessments (HTA) for medicines, in view of their reimbursement in the national health insurance system and in the national health programs.

The NAMMD proposes to the Ministry of Health the INN Reimbursement List, which shall be approved by Government Decision.

2. Do regulators require HTA studies in your country?

Yes. In order for a medicinal product to be reimbursed in Romania, the product should be included in the list of the international non-proprietary names (“INN Reimbursement List”), approved by decision of the Romanian Government.

The inclusion in the INN Reimbursement List of a medicinal product can only be performed following a health technology assessment, carried out by NAMMD.

The HTA report issued by NAMMD following the evaluation should conclude if the INN meets the criteria and the score for being included unconditionally or conditionally in the INN Reimbursement List. In case of the conditional inclusion in the list, the pharmaceutical company should conclude a cost volume or a cost volume result agreement.

3. Do payers require HTA studies in your country?

The reimbursement of a medicinal product in Romania can only be performed if NAMMD issued a favourable HTA decision, based on a specific procedure regulated by the Ministry of Health and NAMMD which takes into account special criteria for deciding the conditional or unconditional inclusion of that medicine in the reimbursement list.

4. How are HTA assessments translated into pricing conditions in your country?

The price of the medicine is one of the elements analysed by NAMMD when performing the health technology assessment, in order to decide if the medicine could be reimbursed unconditionally or conditionally in Romania; In order to determine if a medicinal product could be included in the INN Reimbursement List, the NAMMD takes into account, amongst others, the cost of the therapy (including the price approved by the Ministry of Health) and the HTA reports issued by the competent HTA agencies from France, Great Britain and/or Germany. The HTA report should conclude if the INN meets the criteria and the score for being included unconditionally or conditionally in the INN Reimbursement List, following which NAMMD issues a decision accordingly.

The inclusion in the INN Reimbursement List is approved by the Romanian Government, after the HTA evaluation, by government decision. The medicinal products are included in the relevant sub-list (A, B, C1, C2, C3 or D) of the INN Reimbursement List depending on the level of their reimbursement set by the competent authorities (e.g., 20%, 50%, 90% or 100%);

Following the inclusion of the product’s INN in the INN Reimbursement List, NHIH and, in certain cases, NHIH jointly with the Ministry of Health performs the inclusion of the medicinal product in the Trade Names Reimbursement List. Such list mentions the reimbursement prices of the medicines granted in the health insurance system and in the national health programs.

Once a medicinal product is included in the Trade Names Reimbursement List, it could be acquired by the insured patients at a reduced price or free of charge, depending on the medicine’s price and the value which is reimbursed according to the applicable regulations (i.e., its reimbursement price).

5. How are HTA assessments translated into reimbursement conditions in your country?

Please see item 4 above.

6. Which are the evaluation criteria, processes or models and analyses framework used for HTA in your country?

The HTA evaluation is performed by NAMMD according to certain special criteria, designed to allow a quicker access for medicinal products on the market.

The evaluation criteria are provided, by the relevant Ministry of Health’s Order, in 11 tables, applicable depending on the purpose of the evaluation (e.g. inclusion, exclusion, move of the INN in/from the sub-lists) and the type of medicine subject to evaluation (e.g. new INNs, generics, biosimilars).

The evaluation criteria include various indicators and elements, such as: financial impact, cost-efficiency assessments, therapeutic benefit, therapy cost, as well as HTA reports issued by the competent HTA agencies from France, Great Britain and/or Germany.

7. What is the methodology used in your country for HTA assessment? 

The applicant should submit to NAMMD an application dossier, including a standard application form and other documentation provided by law (e.g. summary of product characteristics, HTA reports issued by the competent HTA agencies from France, Great Britain and/or Germany, the CANAMED Price approved by the Ministry of Health).

Following the submission of the application, NAMMD initiates the evaluation procedure and should communicate its decision within a maximum of 90 days from the receipt of the full necessary documentation.

In case the medicinal product for which the assessment is requested does not have an approved price on the date of submission of the application, the time limit shall be extended by a further 90 days.

NAMMD should assess the application dossiers, based on prioritization criteria provided by law. NAMMD may request the opinion of the Ministry of Health’s advisory committees and may request the applicant to provide additional documentation or information, if needed.

Upon completion of the evaluation, NAMMD should publish the HTA report on its website and it should communicate its decision to the applicant.

8. Which are the other decisions impacted by the assessed outcome in your country?

The HTA decision is relevant for the reimbursement of the medicine in question in the national health insurance system and/or in the national health programs in Romania.

9. Does your HTA evaluation bodies review or inquire other international HTAs during the assessment process? If so, which ones are the usual partners?

When performing the HTA evaluation, NAMMD reviews, among others, the HTA reports issued by other HTA agencies from France (Haute Autorite de Sante), Great Britain (National Institute of Health and Care Excellence/ Scottish Medicines Consortium) and Germany (Institut fur Qualitat und Wirtschaftlichkeit im Gesundheitswesen/ der Gemeinsame Bundesausschuss).

NAMMD does not directly require the international authorities to provide the relevant information in view of the HTA evaluation.

The applicant should provide the HTA reports issued by international authorities, as part of the application dossier.

Also from this Market Access & Health Technology Assessment

Join industry executives in staying informed on the market access and HTA process in Romania. 

1. Have local authorities published recommendations surrounding value assessment dossiers? (If yes please add link)

Following completion of the evaluation, NAMMD publishes the technical report (HTA report) on its website, in the section reserved for health technology assessment and officially communicates the decision to the applicant.

The health technology assessment section on NAMMD’s website includes up-to-date HTA results, information regarding appeals and submitted requests, the applicable legislation, HTA reports, as well as minutes for the settlement of appeals.

The HTA section on NAMMD’s website can be found at the following link: https://www.anm.ro/medicamente-de-uz-uman/evaluare-tehnologii-medicale/

2. Have local authorities published guidelines surrounding value assessment dossiers or their submission process? (If yes please add link)

The Scientific Council of NAMMD occasionally issues decisions for the approval of various guidelines in the field of medicinal products and medical devices, with regard to the procedures performed before the authority.

The Scientific Council of NAMMD elaborates and publishes guidelines on NAMMD’s website, in the section reserved for the legislation applicable to medicinal products of human use, at the following link: https://www.anm.ro/medicamente-de-uz-uman/legislatie/hotarari-ale-consiliului-stiintific/.

The main enactment in this field is the Ministry of Health’s Order no. 861/2014 on approval of criteria and methodology for assessment of health technologies, of documentation to be submitted by applicants, methodological means used in the assessment for inclusion, extension of indications, non-inclusion into or exclusion from the List of International Non- proprietary Names of on-prescription medicinal products as provided to insurers, irrespective of personal contribution, in the frame of the health insurance system, as well as of International Non-proprietary Names of medicinal products provided in national health insurance programs, as well as the means for appeal thereof.

3. Describe the overall process of preparing and submitting a HTA dossier in your country.

The applicant should submit to NAMMD an application dossier, including a standard application form and the extended documentation provided by law (e.g. summary of product characteristics, HTA reports issued by the competent authorities/agencies from France, Great Britain and Germany, the CANAMED Price approved by the Ministry of Health), in both electronic and paper format.

The application receives a registration number at NAMMD and the specialized structure within NAMMD responsible for HTA evaluations shall send confirmation of receipt of the application and the extended documentation submitted by the applicant within a maximum of 5 working days of their submission.

Following the submission of the application, NAMMD initiates the evaluation procedure and should communicate its decision within a maximum of 90 days from the receipt of the full necessary documentation.

In case the medicinal product for which the assessment is requested does not have an approved price on the date of submission of the application, the time limit shall be extended by a further 90 days.

4. Describe the overall content of the HTA dossier in your country.

The application dossier should include a standard application form and the extended documentation provided by law.

The application template, as well as the list setting out the necessary extended documentation are provided in the annexes to the Ministry of Health’s order on HTA evaluation methodology.

The extended documentation includes: HTA reports issued by the competent authorities from France, Great Britain and Germany; the necessary data for the calculation of the therapy costs; the summary of product characteristics; proof of reimbursement in the Member States of the European Union; affidavit of the marketing authorisation holder on the countries where the medicinal product is reimbursed for the respective indication; the price approved by the Ministry of Health; proof of payment of the appropriate fee for the HTA process; the expression of the marketing authorisation holder’s intention to engage in a cost-volume or cost-volume-result mechanism if the individually calculated score is appropriate for conditional inclusion in the INN Reimbursement List.

5. Which are the questions to focus on when preparing a HTA dossier in your country?

The HTA evaluation is performed by NAMMD according to certain special criteria, designed to allow a quicker access for medicinal products on the market.

The evaluation criteria are provided, by the relevant Ministry of Health’s Order, in 11 tables, applicable depending on the purpose of the evaluation (e.g. inclusion, exclusion, move of the INN in/from the sub-lists) and the type of medicine subject to evaluation (e.g. new INNs, generics, biosimilars).

The evaluation criteria include various indicators and elements, such as: financial impact, cost-efficiency assessments, therapeutic benefit, therapy cost, as well as HTA reports issued by the competent authorities from France, Great Britain and Germany.

Each evaluation criterion corresponds to a specific number of points, granted by NAMMD if the medicinal product subject to evaluation fulfils the respective criterion.

Following the calculation of the total score for the evaluated medicinal product, NAMMD decides its unconditional (score greater than or equal to 80 points) or conditional inclusion (score between 60 and 79 points) in the INN Reimbursement List, or, as the case may be, non-inclusion (score less than 60 points) of the INN in the List.

6. Which are the other strategic considerations to take into account when preparing a HTA dossier in your country? 

The evaluation criteria include various indicators and elements, such as: financial impact, cost-efficiency assessments, therapeutic benefit, therapy cost, as well as HTA reports issued by the competent authorities from France, Great Britain and Germany.

The HTA evaluation may be influenced by specific elements relevant to the medicinal product subject to evaluation, such as: comparator medicine, price, the existence of other substitutable medicinal products and prioritisation criteria of the documentation assessment.

A comparator medicine is defined as a medicinal product corresponding to an INN included in the INN Reimbursement List, which has the same approved indication and is intended for the same population segment or subpopulation as the evaluated medicinal product, as the case may be.

The therapy cost, as an evaluation criteria, is influenced by the maximum retail price (with VAT) of the INN or of the relevant generic/biosimilar medicines, if any, listed in the approved CANAMED on the date of evaluation.

The application dossiers are assessed in order of priority, based on the following prioritisation criteria: previously evaluated medicines, with a decision of non-inclusion in the INN Reimbursement List; medicines for conditions in progressive stages of disease with no therapeutic alternative in the List; medicines approved by emergency procedure by the European Medicines Agency; medicines corresponding to INNs for specific treatment of diseases with major public health impact; the chronological order in which the evaluation applications were submitted, for medicinal products not meeting the previous criteria.

Also from this Market Access & Health Technology Assessment

Join industry executives in staying informed on the market access and HTA process in Romania. 

1. In addition to the clinical data obtained through clinical studies please list the data required for:

a. Market approval

In addition to the clinical data obtained through clinical studies, in order to obtain the marketing authorisation issued by NAMMD for medicines, the applicant should submit the following data with the competent authority:

• the name and domicile address or registered office of the applicant and, where applicable, of the manufacturer;
• the name of the medicine;
• the qualitative and quantitative characteristics of all the constituents of the medicine, including the international non-proprietary name (INN) recommended by the World Health Organization, if there is such a name or a reference to the relevant chemical name;
• assessment of the risks that the medicine could present to the environment; this impact is evaluated and, on a case-by-case basis, specific measures are taken to limit it;
• description of the manufacturing method;
• therapeutic indications, contraindications and adverse reactions;
• dosage, pharmaceutical form, method and route of administration, as well as the presumed validity period;
• the explanations regarding the precautionary and safety measures that must be taken for the storage of the medicine, its administration to patients and the elimination of residues, as well as the indication of the potential risks that the medicine presents to the environment;
• description of the control methods used by the manufacturer;
• a written confirmation of the fact that the manufacturer of the medicine has verified compliance by the manufacturer of the active substance with the principles and GMP by conducting audits;
• a summary of the applicant’s pharmacovigilance system;
• the risk management plan, which presents the risk management system that the applicant will introduce for the medicine in question, accompanied by a summary;
• a summary of the product characteristics, a model of the secondary packaging, as well as the package leaflet;
• a document certifying that the manufacturer is authorized to manufacture medicines in its country;
• other documentation and data, as the case may be.

b. Pricing Decisions

In order to obtain the price approval, the applicant should submit the following documents with the Ministry of Health:

• a standard application form, whose template is provided by the Pricing Norms;
• the copy of the marketing authorisation or the decision of the European Commission issued in the framework of the centralized procedure or of the special needs authorization;
• the copy of annexes of the marketing authorisation or of the decision of the European Commission issued within the framework of the centralized procedure or of the special needs authorization, including the summary of the product characteristics and the package leaflet in the language of the country in which it is authorized and its translation into Romanian;
• a comparison with the maximum authorized manufacturer price in the following reference countries: Czech Republic; Republic of Bulgaria; Republic of Hungary; Republic of Poland; Slovak Republic; Republic of Austria; Kingdom of Belgium; Italian Republic; Lithuania; Spain; Greece; Germany;
• a sworn statement of the marketing authorisation holder/its representative that all the information contained in the price approval documentation is complete, correct and fully complies with the method of price calculation provided by law;
• a confirmation by NAMMD of the classification of the medicine;
• excerpt regarding the details of the medicine according to the Official Nomenclature of NAMMD for medicinal products for human use, as published on the ANMDM website.

c. Reimbursement Decisions

In order to be included in the INN Reimbursement List, the applicant should submit an application with the NAMMD (HTA Department), for the purposes of the health technology assessment (HTA).

The HTA dossier includes, amongst others:

• the application form – the template is provided by the HTA legislation;
• HTA reports prepared by other relevant HTA agencies, such as the agencies in France, Great Britain and Germany;
• the data necessary for the calculation of therapy costs, as provided by law;
• the summary of the characteristics of the product approved by the NAMMD or, as the case may be, through the centralized procedure, by the European Commission, through the European Medicines Agency;
• proof of reimbursement in the member states of the European Union – the sworn statement of the marketing authorization holder regarding the countries in which the medicine is reimbursed for the respective indication;
• the price approved by the Ministry of Health (copy from CANAMED price catalogue or price approval decision or proof of submission of the price file to the competent authority that approves drug prices);
• proof of payment of the tariff corresponding to the HTA administrative procedure.

Also from this Market Access & Health Technology Assessment

Join industry executives in staying informed on the market access and HTA process in Romania. 

1. Are there any Managed entry agreements in place in your country? (If so, please list them)

The Romanian legislation provides for the possibility to conclude cost-volume agreements / cost-volume-result agreements with NHIH, which will provide for certain confidential discounts (referred to as the payback contribution) due by the marketing authorisation holders for the reimbursement of certain medicines in the national health insurance system and/or in the national health programs.

These agreements are typically concluded for the medicines which received a conditional reimbursement decision further to the HTA evaluation performed by NAMMD.

The legislation in force provides certain limitations to the types of agreements which could be concluded in connection with the pricing and reimbursement of medicines. It is expected that the legislation will be amended to regulate certain other scenarios where a pharmaceutical company could conclude other types managed entry agreements with the Romanian authorities.

2. For each Individual Managed entry Agreement, describe the fundamentals of the Managed entry Agreement, its rationale and the process for implementing it.

Both the cost-volume and cost-volume-result agreements could be concluded by a marketing authorisation holder/its legal representative with NHIH, in the cases in which the applicant for the reimbursement of a medicinal product in the Romanian health insurance system received from NAMMD a conditional inclusion decision further to the HTA.

The rationale for implementing cost-volume and cost-volume-result agreements is to allow the reimbursement of certain medicinal products under the national health insurance system and/or the national health programs, for the benefit of the patients in Romania.

As regards the implementation of the cost-volume and cost-volume-result agreements, it should be stressed that:

• cost-volume and cost-volume-result agreements based on a conditional inclusion decision issued by NAMMD following the HTA;
• the standard clauses in the cost-volume/cost-volume-result agreements are provided by the law;
• the marketing authorisation holder/its legal representative should pay a payback contribution for the inclusion of the concerned medicines in the INN reimbursement List (i.e., ranging between 25% – 75% of the value borne by the state, for each quarter);
• the performance of the cost-volume and cost-volume-result agreements is monitored by the NHIH.

3. When should this Managed Entry Agreement be considered?

Both the cost-volume and cost-volume-result agreements could be concluded by a marketing authorisation holder/its legal representative with NHIH, in the cases where the NAMMD issued a conditional reimbursement decision further to the HTA concerning the reimbursement of a medicinal product in the Romania.

4. Which are the specific requirements to implement the Managed Entry Agreement.

The specific requirements to implement the cost-volume and cost-volume-result agreements are, as follows:

• the duration is of 1 (one) year, as provided by law, with the possibility to renegotiate and conclude new agreements annually;
• the medicines subject to cost-volume and cost-volume-result agreements will be prescribed by the physicians and released to the patients in Romania;
• the number of eligible patients is decided by the Ministry of Health’s specialty commissions and published by the NHIH before the commencement of the negotiation proceedings;
• the performance of the cost-volume and cost-volume-result agreements is monitored by the NHIH;
• the marketing authorisation holder/its legal representative should pay a quarterly payback contribution (i.e., ranging between 25% – 75% of the value borne by the state, for each quarter).

5. What is the potential impact on the product uptake?

N/A

6. What are the potential challenges associated with this Managed Entry Agreement?

The potential challenges associated to cost-volume and cost-volume-result agreements relate mainly to the fact that such agreements could be considered insufficient for the long-term situations, given their annual renegotiation and conclusion and complex proceedings provided by the law in this respect, the calculation of the relevant number of eligible patients, the payback contribution due by marketing authorisation holders, the issuance of the therapeutic protocols relevant for the prescription of medicines and for the implementation of the agreements, etc.

Also from this Market Access & Health Technology Assessment

Join industry executives in staying informed on the market access and HTA process in Romania. 

1. Which are the main actors involved in public procurement and tendering?

The administrations, bodies and institutions in charge of public procurement and tendering for medicinal products in Romania are:

At centralized/national level:

• the Ministry of Health, which organizes national tenders for the acquisition of medicinal products and should conclude framework agreements on behalf and for the public health units within the Ministry of Health’s and the local public administration authorities’ structure (g., for public hospitals).

The list of the medicines acquired by the Ministry of Health at centralized level should be updated every year.

In principle, for the acquisition of the relevant medicines the Ministry of Health should organize a public tender procedure where any interested party could participate.

• UNIFARM, a company under the Ministry of Health’s subordination, whose main business object is supplying the healthcare system with medicines, vaccines and other products originating from both the national production and import/ EU intracommunity trade.

UNIFARM cooperates with the Ministry of Health for the implementation of the national health programs organized and financed by the Ministry, pursuant to the Health Law, and has different responsibilities in relation to the acquisition of medicines in Romania.

• the National Office for Centralized Acquisitions (the “NOCA”), a public institution with legal personality, subordinated to the Ministry of Finance, which was set up in 2018 and is entirely financed from the state budget through the budget of the Ministry of Finance;

At local level: the hospitals, which are the main contracting authorities (public partners) and, inter alia:

• launch public tenders based on the needs of medicines reported by healthcare professionals (HCPs);
• under certain conditions, can purchase medicines under a direct acquisition procedure;
• set the necessary documentation for the performance of the public tender procedure, including the aspects relevant for the negotiation and conclusion of agreements.

2. What are the main characteristics of the public procurement and tendering system?

By law, when a Romanian contracting authority (e.g., a public authority, a public company and certain other entities financed from public funds) wishes to acquire certain goods, it should perform such acquisition in accordance with the public procurement legislation.

As a rule, the contracting authority should launch a public tender (where all the interested entities could participate). However, under certain conditions, the authority can perform a direct acquisition procedure.

As regards public tenders carried out in connection with medicinal products, the following should be noted:

• normally, the hospitals launch the public tender based on the needs of medicines reported by healthcare professionals (HCPs); under certain conditions, hospitals can perform a direct acquisition procedure;
• hospitals set the necessary documentation for the performance of the public tender procedure, including the negotiation and conclusion of agreements;
• the public tenders are carried out periodically;
• the rule is that the public tenders for medicinal products refer to the international non-proprietary name (INN), not the trade name;
• as a result of the tender, the parties conclude a framework agreement; subsequent agreements usually follow.

Also from this Market Access & Health Technology Assessment

Join industry executives in staying informed on the market access and HTA process in Romania. 

1. Please describe the main cost containment policies in place in your country and their fundamental principles 

a. Pricing and impact of generic/biosimilar approval

The price of off-patent innovative medicines cannot exceed, as a rule:

• the level of the innovative reference price (computed according to a special 65% reference rule, depending on the patent expiry date and on the presence of generic alternatives on the market); or,
• as the case may be, the level of the innovative reference price (computed according to a special 80% reference rule, depending on the patent expiry date and on the presence of biosimilar alternatives on the market).

b. Clawback/Payback/Discounts/Rebates

As a rule, the marketing authorisation holders and their legal representatives should pay on a quarterly basis the clawback tax for the medicines traded on the Romanian market; certain medicines are exempted from the payment of the clawback tax.

The marketing authorisation holders should pay the payback tax for the medicines which are reimbursed in Romanian based on a cost volume agreement.

NHIH could conclude additional protocols with pharmaceutical companies concerning special discounts or rebates for medicines.

c. Existence of Price/Volume agreements in the frame of public tendering

N/A

d. Existence of price freezes and cuts

• Price freezes

The Romanian legislation in force provides for the possibility of the Ministry of Health to freeze the prices of medicinal products.

By law, in the case of a price freeze, imposed on all medicines or only a category of medicines, the Ministry of Health carries out an analysis at least once a year to determine whether the macroeconomic conditions require maintaining the freeze.

Within 90 days from the beginning of this analysis, the Ministry of Health should announce price increases or decreases, if any.

Exceptionally, marketing authorisation holders can ask for a derogation from the price freeze, for specific reasons.

• Prices cuts

The Romanian legislation in force provides for the possibility of the Ministry of Health to reduce the prices of medicinal products.

The Ministry of Health could request the reduction of the CANAMED manufacturer price, e.g., if the Ministry of Health or NAMMD find out that the marketing authorisation holder could supply the medicines in Romania at a level below the CANAMED manufacturer price.

e. Post-launch monitoring of prescriptions/sales

Post-launch monitoring of prescriptions/sales is quite abundantly regulated by the Romanian legislation which expressly provides for reporting obligations for several relevant actors, as follows:

• wholesale distributors/importers/manufacturers should report on a daily basis to NAMMD and the Ministry of Health the stocks and commercial operations, including distribution outside the territory of Romania, carried out with medicines for human use from their own portfolio having the price approved in the CANAMED;
  Also, wholesale distributors/importers/manufacturers should report to NAMMD, at the end of each calendar month, the situation regarding commercial operations, including parallel import, respectively the distribution of medicines outside the territory of Romania, in other states from the European Economic Area, carried out with medicines for human use from their own portfolio;
• closed and open circuit pharmacies should report on a daily basis to NAMMD and the Ministry of Health the stocks and commercial operations, including the release on consignment, as the case may be, for medicines having the price approved in the CANAMED;
• hospitals and dialysis centers should report monthly to the health insurance houses, the consumption of medicines, for the purposes of the computation of the clawback/payback contribution;
• open-circuit pharmacies report the monthly consumption of medicines, under the terms of the framework contract that regulates the conditions for providing medical assistance within the social health insurance system, for the purposes of the computation of the clawback/payback contribution.

The reporting provided under items (iii) and (iv) above is also made electronically, by using the SIUI (a specially designed program/system).

f. Existence of Generic Substitution Policies

In Romania, there were several initiatives for setting the cases in which a generic substitution is possible.

g. At prescriber level

Medicinal products with or without personal contribution reimbursed in the national health insurance system should be prescribed by physicians who are in contractual relationship with the health insurance houses.

As a rule, the physicians should prescribe the medicinal products by mentioning the relevant international non-proprietary name (INN) on the prescription. However, in medically justified cases and in case of biological products, the physicians could also mention on the prescription the relevant trade name of the prescribed products.

h. At retail level

The patients will acquire the reimbursed medicinal products by presenting the prescriptions to the suppliers of medicinal products (e.g., pharmacies) which are in contractual relationship with the health insurance houses.

Unless the physician recommends a certain brand (trade) name, the pharmacist’s recommendation regarding the trade names corresponding to the INN prescribed by the physician should be in the ascending order of the price, starting with the cheapest medicinal product with the respective non-proprietary name (INN).

2. Are there any other policies in place aiming at cost control via incentive programs targeting the different actors (pharma companies, wholesalers, retailers, prescribers etc)?

The Romanian legislation does not expressly regulate other policies in place aiming at cost control via incentive programs.

Also from this Market Access & Health Technology Assessment

Join industry executives in staying informed on the market access and HTA process in Romania. 

1. Has an essential or priority drug list been published in your country? (If so provide the link)

The list of essential medicinal products was approved by means of a Ministry of Health’s order, published in the Official Gazette of Romania in July 2021. The list currently provides 152 INNs that classify as essential drugs in Romania.

Also from this Market Access & Health Technology Assessment

Join industry executives in staying informed on the market access and HTA process in Romania. 

1. What is the definition of an orphan drug in your country?

The Romanian legislation defines “orphan drug” by referring to the criteria provided for by Regulation (EC) no. 141/2000 on orphan medicinal products (“Regulation no. 141/2000”), which is directly applicable in Romania.

According to Regulation no. 141/2000, a medicinal product could be designated by the European Medicines Agency as an orphan medicine when:

• it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than 5 in 10,000 persons in the Community when the application is made; or
• it is intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the Community and that without incentives it is unlikely that the marketing of the medicinal product in the Community would generate sufficient return to justify the necessary investment; and
• there is no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in the Community or, if such method exists, that the medicinal product will be of significant benefit to those affected by that condition.

2. Describe the pricing process of orphan drugs in your country.

At the local level, NAMMD is the competent authority which performs the classification of the medicinal products, including for the ones which fall in the category of orphan medicines. According to the Romanian Pricing Norms, as a rule, the orphan medicinal products are considered innovative medicines and the same pricing rules shall apply.

The competent authority which approves the prices of prescription-only (Rx) medicines, including orphan medicines, is the Ministry of Health.

By law, the manufacturer price for Romania should be lower than or (at most) equal to the lowest price of the same medicinal product in 12 (twelve) comparison countries (Czech Republic, Bulgaria, Hungary, Poland, Slovakia, Austria, Belgium, Italy, Lithuania, Spain, Greece and Germany).

Hence, the price of orphan medicinal products should be proposed by the marketing authorisation holder or its representative, by comparison with the prices of such medicinal products in the 12 reference countries.

The price should be approved by the Ministry of Health within 90 days as of receiving the price application dossier and is valid for 1 (one) year.

Further to the approval of the manufacturer price, the maximum wholesale and retail prices are calculated by the Ministry of Health according to a special formula, by considering the maximum applicable wholesale and pharmacy margins set forth by the applicable regulations; the approved prices are published in the national price catalogues.

Every year, the marketing authorisation holders and/or their representatives should submit a price correction dossier with the Ministry of Health for updating the price of each medicine placed on the Romanian market; the updated price will be valid also for 1 (one) year.

3. Describe the reimbursement process of orphan medicines in your country.

Orphan medicines could be reimbursed in the Romanian health insurance system pursuant to the same rules applicable to medicinal products in general, if the following conditions are met: (1) they have a valid marketing authorisation; (2) their price for Romania is approved by the Ministry of Health and (3) they are included in the INN Reimbursement List, approved by the Romanian Government based on the health technology assessment (HTA) performed by NAMMD.

The HTA legislation stipulates specific conditions and special evaluation criteria for orphan drugs, which could improve their chances to receive a favourable HTA decision, pursuant to NAMMD’s prioritization criteria of the evaluation for such medicines.

If NAMMD issues a favourable HTA decision, the medicines in question should be included in the INN Reimbursement List. Subsequently, NHIH and/or the Ministry of Health will include the medicine in question in the Trade Names Reimbursement List, a list which mentions the trade names and the reimbursement prices for the medicines reimbursed in the national health insurance system and in the national health programs.

4. Other than the clinical studies required, do the data and studies required for the pricing and reimbursement of orphan drugs differ from that of other drugs?

As a rule, orphan medicines are considered innovative medicines and the appropriate pricing rules shall apply.

The norms on the health technology assessment procedure provide for certain special rules as regards the documentation and the information which should be submitted for the HTA evaluation of orphan medicines, in view of their reimbursement in the national health insurance system and in the national health programs.

Thus, in order to receive a favourable decision for the inclusion of the orphan drug in the INN Reimbursement List, the HTA legislation requires the applicant to submit to NAMMD one of the following documents:

• the clinical trial authorisation and the interim/final report proving that a clinical trial of the medicinal product evaluated for the submitted indication has been conducted on the territory of Romania;
• the EUnetHTA assessment for the submitted indication;
• the authorisation for use in last resort treatments in Romania for the medicinal product evaluated for the submitted indication; and/or as the case may be
• information regarding the donation of the medicine in question for part of the population eligible for treatment.

Also from this Market Access & Health Technology Assessment

Join industry executives in staying informed on the market access and HTA process in Romania. 

1. What is the definition of a vaccine in your country?

The Health Law classifies vaccines as immunological medicinal products (any medicinal product consisting of vaccines, toxins, serums or allergenic products).

2. What are the classifications of vaccines in your country?

The in force legislation in Romania does not expressly provide for a definition of vaccines. The Health Law specifies that the notion of vaccines, toxins or serums refer especially to:

• agents used to produce active immunity (g. holeric vaccine, BCG, polio vaccine, variola vaccine);
• agents used to diagnose immune status (g. tuberculin);
• agents used to produce passive immunity (g. smallpox globulin).

3. Describe the pricing process for vaccines in your country (based on their classifications).

The competent authority which approves the prices of prescription-only (Rx) medicines, including vaccines, is the Ministry of Health.

By law, the manufacturer price for Romania should be lower than or (at most) equal to the lowest price of the same medicinal product in 12 (twelve) comparison countries (Czech Republic, Bulgaria, Hungary, Poland, Slovakia, Austria, Belgium, Italy, Lithuania, Spain, Greece and Germany).

Hence, the price of vaccines should be proposed by the marketing authorisation holder or its representative, by comparison with the prices of such medicinal products in the 12 reference countries.

The price should be approved by the Ministry of Health within 90 days as of receiving the price application dossier and is valid for 1 (one) year.

Further to the approval of the manufacturer price, the maximum wholesale and retail prices are calculated by the Ministry of Health according to a special formula, by considering the maximum applicable wholesale and pharmacy margins set forth by the applicable regulations; the approved prices are published in the national price catalogues.

Every year, the marketing authorisation holders and/or their representatives should submit a price correction dossier with the Ministry of Health for updating the price of each medicine placed on the Romanian market; the updated price will be valid also for 1 (one) year.

4. Describe the reimbursement approval process for vaccines in your country (based on their classifications).

In principle, all medicines could be reimbursed in the Romanian health insurance system pursuant to the same rules applicable to medicinal products in general, if the following conditions are met: (1) they have a valid marketing authorisation; (2) their price for Romania is approved by the Ministry of Health and (3) they are included in the INN Reimbursement List, approved by the Romanian Government based on the health technology assessment (HTA) performed by NAMMD.

If NAMMD issues a favourable HTA decision, the medicines in question should be included in the INN Reimbursement List. Subsequently, NHIH and/or the Ministry of Health will include the medicine in question in the Trade Names Reimbursement List, a list which mentions the trade names and the reimbursement prices for the medicines reimbursed in the national health insurance system and in the national health programs.

5. Other than the clinical studies required, do the data and studies required for the pricing and reimbursement of vaccines differ from that of other drugs?

With regard to pricing, vaccines fall within the category of Rx medicinal products and the appropriate pricing rules shall apply, including the price comparison with the prices approved in the 12 reference countries provided by law. In principle, the same is applicable for the HTA evaluation and for the inclusion in the reimbursement list.