Regulatory, Pricing and Reimbursement
The legal framework for regulatory, pricing and reimbursement in Romanian Pharma. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for USD 99.
1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?
The regulatory authorities competent in these fields are:
- the Ministry of Health (http://www.ms.ro/);
- the National Agency for Medicines and Medical Devices (https://www.anm.ro/); and
- the National Health Insurance House (http://www.cnas.ro/).
2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?
The main enactment in the pharmaceutical and healthcare fields in Romania is Law no. 95/2006 on healthcare reform, as republished and further amended and supplemented (the “Health Law”), which regulates, amongst others:
- for medicinal products (including biologicals): the marketing authorization, manufacturing, import, distribution, labelling, advertising, promotion and pharmacovigilance activities;
- for medical devices: the trade, distribution and the performance of certain services and activities.
The secondary legislation consists of Government Decisions, Government Ordinances, Orders, Decisions and Norms issued by the Ministry of Health, the National Agency for Medicines and Medical Devices (NAMMD) and the National Health Insurance House (NHIH), such as:
A. Marketing Authorization:
- Ministry of Health’s Order no. 1448/2010 approving the Regulations regarding the marketing authorization and supervising of medicinal products for human use;
- Government Decision no. 54/2009 on the conditions for the trade of medical devices;
- Government Decision no. 798/2003 on the conditions for the trade and use of in vitro diagnostic medical devices;
- Ministry of Health’s Order no. 1009/2016 on the registration of medical devices in the national database.
- Ministry of Health’s Order no. 761/2015 approving the Guidelines on the good distribution practices for the wholesale distribution of medicinal products;
- Ministry of Health’s Order no. 131/2016 approving the Norms on the authorization of the wholesale distribution units of medicinal products;
- Ministry of Health’s Order no. 1008/2016 approving the Norms on the authorization of the activities in the medical devices field.
- 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.
- Government Decision no. 140/2018 for the approval of services packages and of the Framework Agreement on the conditions of providing medical assistance within the social health insurance system for 2018-2019;
- Government Decision no. 155/2017 for the approval of national health programs for 2018 and 2019;
- Government Decision no. 720/2008 for the approval of the List of international non-proprietary names (INNs) of medicines out of which insured persons benefit with or without personal contributions, based on medical prescription, within the social health insurance system, and of the international non-proprietary names of medicines provided under the national health programs.
3. What are the steps to obtain authorization to develop, test, and market a product?
A. Medicinal products (including biologicals):
In order to perform clinical trials on medicinal products for human use, it is necessary to obtain the authorization of the National Agency for Medicines and Medical Devices (“NAMMD”) and the favorable opinion of the National Bioethics Committee for Medicinal Products and Medical Devices (“NBCMMD”).
The laboratories and the other units performing the tests should be duly authorized by NAMMD and by the Ministry of Health and/or the competent health department.
To trade a medicinal product on the Romanian market, it is necessary to obtain a marketing authorization and a price approval order for the respective product.
The marketing authorization is issued either:
- at national level, by NAMMD, under the national evaluation procedure or under the mutual recognition or decentralized procedures; or
- at centralized level, by the European Medicines Agency (“EMA”).
The authorization procedure should be completed within a maximum of 210 days from the date of filing of a valid application. During this procedure, the regulatory authority shall assess, amongst others, the results of the pharmaceutical and pre-clinical tests, as well the results of the clinical trials.
After obtaining the marketing authorization, the medicine’s price should be approved by the Ministry of Health. By law, the Ministry should issue an order approving the medicine’s price within 90 days from the date of filing of the price application dossier.
The prices of medicinal products (i.e., the manufacturer price and the maximum wholesale and retail prices) are published in the National Public Catalogue (the “Public Catalogue”) and in the National Catalogue of the Prices of Medicinal Products Authorized for Marketing in Romania (also known as the “CANAMED”).
The entities performing the manufacturing, the import, the wholesale distribution or the retail distribution activities should be duly authorized for performing such activities. In Romania, the manufacturing, the import and the wholesale distribution authorizations are issued by NAMMD, while the pharmacy license is issued by the Ministry of Health.
Furthermore, certain medicinal products, including the ones having in their composition psychotropic and narcotic substances, are subject to special authorization, distribution and prescription rules.
B. Medical devices:
Medical devices should have the CE marking in order to be traded in Romania. An additional registration step is the inclusion of the medical device in the National Database of Medical Devices, held by NAMMD.
The entities performing the manufacturing, the import, the wholesale distribution and the retail distribution activities should be duly authorized by NAMMD.
4. What are the approximate fees for each authorization?
A. Medicinal products (including biologicals):
The administrative fees for the marketing authorization of a medicinal product under the national procedure are EUR 1,000 (paid when the marketing authorization dossier is submitted with NAMMD) plus EUR 9,500 (due for the evaluation of the marketing authorization dossier).
The fees are generally lower for the evaluation of generic medicines (e.g., EUR 5,700), for biosimilars (e.g., EUR 6,650), and for medicines authorized under the mutual recognition and/or decentralized procedure. The exact value of the fees are determined by NAMMD by taking into account the particular situation of each product.
B. Medical devices:
There is no administrative fee for the registration of medical devices by NAMMD in the National Database of Medical Devices.
5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?
A. Medicinal products (including biologicals):
By law, the marketing authorization issued by NAMMD is valid for 5 (five) years.
In view of its renewal, the marketing authorization holder should submit to NAMMD, not later than 9 (nine) months before the expiry date:
- a consolidated version of the dossier on the quality, safety and efficacy, an evaluation of data in the reports on suspected adverse reactions and the updated periodic safety reports;
- the variations which occurred after the issuance of the marketing authorization.
After its renewal, the marketing authorization is valid for an unlimited period, unless NAMMD decides to renew it for an additional five-year term only, due to pharmacovigilance-related reasons.
B. Medical devices:
The registration of medical devices in the National Database of Medical Devices is valid for an unlimited period, as long as there is no change which would require the amendment of the registration.
6. How does the authorization process differ between brand-name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?
The marketing authorization procedure for generic products is simplified, compared to the procedure for the innovative (brand-name) medicinal products.
Thus, after 8 (eight) years from the issuance of the marketing authorization of an innovative medicinal product, its generic can apply for marketing authorization without supplying the results of the pre-clinical tests and of the clinical trials. To this end, the generic applicant should prove that the reference innovative product was authorized for at least 8 years in Romania, in the European Union under the centralized procedure or in another EU Member State.
In such case, the generic product cannot be placed on the market until 10 years have passed from the initial authorization of the reference innovative product.
7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug +biologic + device) regulated?
By law, in the case of combinations between a medical device and a medicinal product:
- the device shall be deemed a medical device, if it is designed for administering a medicinal product; in this case, the administered product is subject to the medicines’ regulations;
- the combination product shall be subject to the regulations applicable to medicines, if such device is placed on the Romanian market as a single, complete product, exclusively intended to be used in the given combination.
For the marketing authorization of medicinal products containing a combination of active substances which are in the composition of certain authorized medicines, but have not yet been used in such combination for a therapeutic purpose, it is necessary to submit the results of new pre-clinical tests and clinical trials for the respective combination.
8. How is compliance with regulation monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?
NAMMD is the competent regulatory authority that monitors the medicines placed on the Romanian market and the activities carried out by the pharmaceutical companies, manufacturers, distributors, importers and exporters of medicines. In this respect, NAMMD:
- performs quality assessments on the authorized medicinal products, carrying out inspections at manufacturing and distribution facilities and other monitoring activities;
- supervises the pharmacovigilance activities designed to collect information on the risks of medicinal products placed on the market;
- requires post-authorization safety assessments, if there are concerns about the risks of certain medicinal products;
- performs inspections for ensuring the compliance with the guidelines on good manufacturing practices and with the guidelines on good distribution practices;
- applies various fines and sanctions, including the suspension and the withdrawal of certain medicinal products from the market, and the suspension and the withdrawal of the authorizations of the entities in breach of the pharmaceutical legislation.
In view of monitoring compliance in the medical devices field, NAMMD:
- performs periodic audits and evaluations regarding the medical devices placed on the market, and other activities for supervising the activities in this field, as well as inspections at the premises of the entities involved in the medical devices activities;
- applies various fines and sanctions to the entities and persons in breach of the medical devices legislation.
9. What is the potential range of penalties for noncompliance?
According to the Health Law, failure to observe the legislation in the pharmaceutical and healthcare fields can trigger the disciplinary, civil, administrative or criminal liability, depending on the circumstances of each case.
In the pharmaceutical field the authorities may apply fines, ranging between RON 10,000 (roughly EUR 2,200) and RON 100,000 (roughly EUR 22,000) per breach, as well as other sanctions, such as:
- the suspension, withdrawal or cancellation of the authorization; and
- the withdrawal of the product from the market.
In the medical devices field, the fines range between RON 2,000 (roughly EUR 450) and RON 15,000 (roughly EUR 3,200) per breach.
When applying a fine or other main sanction, the authorities are entitled to apply additional (complementary) sanctions, such as:
- the suspension or, as the case may be, cancellation of the approval/endorsement/authorization for carrying out the activity;
- the closing of the unit;
- the freezing of bank accounts;
- the suspension of the activity of the relevant undertaking;
- the withdrawal as a temporary or final measure of the license or approval for certain operations;
- seizure of the goods used or resulting from the offence;
10. Is there a national healthcare system? If so, how is it administered and funded?
The Romanian public health insurance system is coordinated at national level by the National Health Insurance House (“NHIH”), which has in its subordination 42 local public health insurance houses.
NHIH has, among others, the following responsibilities:
- 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.
The financing of the Romanian health insurance system is ensured by mandatory contributions to the public health insurance system by individuals and legal entities, which are collected in the National Sole Social Health Insurance Fund (“NSSHIF”), managed by the NHIH.
The NSSHIF is used for funding the entire public health insurance system, including the national health programs, for providing medical services, medicinal products and medical devices to insured individuals.
Other financing sources include grants from the state budget and from the budget of the Ministry of Health and local authorities, and donations and sponsorships made by individuals and legal entities.
Moreover, pharmaceutical companies pay a clawback tax for certain medicines traded on the local market, which is also meant to cover the financing of the public health insurance system.
11. How does the government (or public) healthcare system function with private sector healthcare?
In Romania, public and private healthcare providers operate in parallel.
The insured patients can receive medical services, in the public health insurance system, either:
- in public healthcare units; or
- in private healthcare units, which have concluded reimbursement agreements with the competent health insurance house (i.e., the NHIH or a house in its subordination).
12. Are prices of drugs and devices regulated and, if so, how?
The price of: (a) medicinal products released based on medical prescription (Rx medicines) and (b) over-the-counter medicinal products (OTC medicines) prescribed to patients in the social health insurance system, has to be approved by the Ministry of Health. The price of other OTC medicines can be established independently by their marketing authorization holders.
To obtain the price approval, the medicine’s marketing authorization holder should submit an application to the Ministry of Health, together with certain documents regarding the prices of the same product in the following 12 reference countries: Czech Republic, Bulgaria, Hungary, Poland, Slovakia, Austria, Belgium, Italy, Lithuania, Spain, Greece and Germany.
As a rule, the manufacturer price proposed by the marketing authorization holder for Romania should be lower than or (at most) equal to the lowest price of the same medicinal product in the 12 comparison countries. However, the price of immunologic medicines and of medicines derived from blood or human plasma (e.g., albumin, coagulation factors and human immunoglobulin) 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.
The price of generic medicinal products should be lower than or (at most) equal to the generic reference price, which is set at a value representing 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 – representing 80% of the price of the reference innovative medicine.
Pursuant to a new rule implemented in 2018, the price of off-patent innovative medicines should be lower than or (at most) equal to the generic reference price or, as the case may be, the innovative reference price, depending on the patent expiry date.
According to the pricing norms, 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.
If a medicine is reimbursed in the national health insurance system, its reimbursement price shall be approved according to certain specific rules applicable to each reimbursement list.
The price of medical devices is not regulated. However, in the case of reimbursed medical devices, their reimbursement value is approved by the Ministry of Health and/or the NHIH.
13. How are drugs and devices used by patients paid for? What roles do public and private payers play?
Patients insured in the national health insurance system can receive medicinal products and/or certain medical devices from pharmacies which have concluded reimbursement agreements with health insurance houses, either free of charge or by making a co-payment.
The price of a medicine can be reimbursed at a level of 20%, 50%, 90% or 100%, depending on the reimbursement list where the medicine is included. The list of the international non-proprietary names (“INNs”) reimbursed in Romania is approved by the Government. Based on the INN Reimbursement List, the NHIH and the Ministry of Health issue the lists providing the trade names and reimbursement values applicable for medicinal products in the social health insurance system and the national health programs.
Certain medical devices are reimbursed in the national health insurance system, at a value established by the Ministry of Health and/or the NHIH.
NHIH and the other public health insurance houses in its subordination cover the reimbursed value, by providing the reimbursement amounts to the pharmacies releasing the reimbursed medicinal products and/or medical devices, based on special supply agreements.
The role of private payers in relation to the reimbursement of medicines and/or medical devices is not expressly regulated by the legislation currently in force in the healthcare field.
14. Who dispenses drugs and devices to patients and how are those dispensers compensated?
Medicinal products and medical devices are prescribed by physicians and are dispensed to the patients by pharmacies and hospitals.
As a rule, the insured patients obtain the reimbursed medicines free of charge or with a price reduction from a pharmacy which has previously concluded a supply (reimbursement) agreement with the NHIH or with the local health insurance house.
Thus, pharmacies in a contractual relationship with the health insurance houses are entitled to be reimbursed the countervalue of the medicinal products that were previously dispensed to the patients.
To this end, pharmacies submit reimbursement data for each month, to the competent health insurance house. The health insurance house should pay the pharmacies the reimbursement amounts within 60 days of submitting the relevant documentation.
15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?
According to applicable legislation, the prescribing physicians have various obligations related to patient care, information and safety, among which:
- to observe the confidentiality of the patients’ medical data;
- to inform the patient on the purpose and nature of the medical intervention, as well as on the consequences and risks of such procedure, to ensure that every medical intervention is performed based on the informed consent of the patient or their representative;
- to comply with the anti-bribery and conflict of interest obligations, and not to receive any sponsorships or improper advantage meant to influence their medical decision;
- to declare the sponsorships received from pharmaceutical and medical devices companies to NAMMD, which will make such information available to the public.
The medicines are usually prescribed by their international non-proprietary name, and not their trade name (except for biologicals and certain other products), by using the electronic prescription form.
The pharmacists dispensing the medicinal products and medical devices to the patients are obliged to ensure the confidentiality of the medical data and to provide adequate information to the patients regarding the relevant products. If the physician prescribes a certain international non-proprietary name (and does not mention the medicine’s trade name), the pharmacist should first recommend the cheapest product having the respective international non-proprietary name.
The pharmacists should comply with certain conflict of interests and incompatibilities obligations set forth by the applicable legislation.