Legal & Regulatory > Estonia > Regulatory, Pricing and Reimbursement

All legal aspects surrounding regulatory, pricing and reimbursement in Estonia. Prepared in association with TGS Baltic, a leading law firm in Estonia, this is an extract from The Pharma Legal Handbook: Baltics, 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 authority with jurisdiction over medicines and biologicals is the State Agency of Medicines (SAM). The authority responsible for applying and enforcing the regulatory framework in relation to medical devices is the Health Board.

2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?

The primary national legislation for the authorization and pricing of medicines and biologicals is the Medicinal Products Act (MPA) and its regulations. Authorization of medical devices is primarily regulated by the Medical Devices Act (MDA) and its regulations. Pricing of medical devices is not regulated. Reimbursement of medicines, biologicals and medical devices is mainly regulated by the Health Insurance Act (HIA) and its regulations.

3. What are the steps to obtain authorization to develop, test, and market a product?      

a) MEDICINES

For manufacture of medicinal products, an activity license for the manufacture of medicinal products must be obtained.

For every specific medicinal product, marketing authorization valid in Estonia is required. Marketing authorization is not required for:

• medicinal products prepared as magistral and officinal formulae and medicinal products divided up into retail packaging by pharmacies;
• medicinal products imported based on a single import authorization and a single distribution permit granted by the State Agency of Medicines;
• whole blood and blood components;
• herbal substances;
• medicinal products prescribed for use on aquarium fish, cage birds, terrarium animals, small rodents as well as ferrets and rabbits kept as pets provided that the use of such medicinal products on any other animal species is precluded;
• advanced therapy medicinal products that have been, by way of exception, made on the basis of a doctor’s prescription and subject to doctor’s professional liability for the purpose of use by a specific patient upon provision of in-patient health services in Estonia.

Please see the Marketing, Manufacturing, Packaging & Labeling, Advertising  for details on different procedures for obtaining a marketing authorization in Estonia.

b) MEDICAL DEVICES

Specific authorization for manufacture of medical devices is not required; however, manufacture of medical devices may, depending on the circumstances, include activities for which authorization is required (for example handling of chemicals, usage of radiation, etc.).

Basic requirements for placing the medical device on the market and putting it into service are the following:

• the device meets the requirements of applicable legislation;
• clinical evaluation has been provided for the device, and where necessary, a clinical investigation of the device has been conducted;
• conformity assessment of the device has been carried out;
• the device is accompanied by conforming information necessary for identification of the manufacturer and for the safe use of the device for its intended purpose.

To market a medical device, marketing authorization is not required, but at least 10 days before the medical device is placed on the market, the Health Board must be notified thereof.

4. What are the approximate fees for each authorization?

a) MEDICINES

State fee for the review of application for issue of an activity licenses for manufacture of medicinal products is EUR 1,000.

Fees for the review of application for issue of a marketing authorization of a medicinal product are the following:

• state fee is EUR 32;
• fee for professional assessment of the application is up to EUR 1,275;
• additional fee is EUR 14,000 (initial decentralized marketing authorization procedure or marketing authorization procedure of mutual recognition where the reference country is Estonia).

State fee for the review of an application for clinical trial of a medicinal product is EUR 385.

b) MEDICAL DEVICES

As specific authorization for manufacture of medical devices and marketing authorization of a medical device is not required, specific state fees are not applicable.

5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?         

A marketing authorization of a medicinal product is initially granted for 5 years. After 5 years, a marketing authorization is renewed for an unspecified term (except in cases where the marketing authorization is based on the assessment report provided by a competent authority of another Member State of the European Economic Area, in which case the authorization is renewed for the period of validity of the marketing authorization in the reference state).

Depending on the safety information of a medicinal product, including a small number of patients who have used the medicinal product, the State Agency of Medicines may decide that a second limited term of validity of 5 years is required.

For the renewal of the marketing authorization, a marketing authorization holder must submit an application together with supplementary documentation to the State Agency of Medicines at least 9 months before the expiry of the authorization.

Fees for the renewal are the following:

• state fee EUR 32;
• fee for professional assessment of the application is up to EUR 639;
• additional fee EUR 3,000 (decentralized marketing authorization procedure or marketing authorization procedure of mutual recognition where the reference country is Estonia).

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 main difference, in general terms, is that for brand-name products, the safety and efficacy must be demonstrated and for generic products, the interchangeability and bio-comparability must be demonstrated (Please see the Marketing, Manufacturing, Packaging & Labeling, Advertising  for details).

There are no differences for local manufacturers versus foreign-owned manufacturers. However, only marketing authorizations holders whose place of residence or seat is located in a Member State of the European Economic Area can apply for the marketing authorization.

7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated?

A) Combination products drug + drug and drug + biologic fall under regulatory framework of medicinal products and Medicinal Products Act shall be applied to these combination products.

B) Combination products drug + device, biologic + device and drug + biologic + device:

• If a medical device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, the relevant medical device shall be governed by the Medicinal Products Act and Medical Devices Act shall be applied only as far as safety and performance related to device features are concerned.
• Where a medical device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in the Medicinal Products Act and which is liable to act upon the body with action ancillary to that of the device, only the requirements of Medical Devices Act shall be applied to the device.
• A device intended for the administration of medicinal product shall be deemed to be a medical device and the provisions of Medical Devices Act shall be applied to it.

The State Agency of Medicines has the right to classify the status of substances and products as medicinal products, and of products as homeopathic preparations. If a product complies with the characteristics specified in Medical Devices Act, the Health Board has the right to identify the product as a medical device.

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?

a) MEDICINES

The State Agency of Medicines exercises state and administrative supervision over the performance of Medicinal Products Act and legislation established on the basis thereof. SAM is empowered to enter into premises and facilities, to examine premises and facilities, to take movables into storage, to take samples of products and substances, to question and summon persons, to require presentation of documents, etc., to monitor and evaluate compliance with applicable legislation.

In respect of pharmacovigilance, the pharmacovigilance system is used by the State Agency of Medicines and marketing authorization holders. The system is enacted by the Medicinal Products Act and is designed to monitor the safety of authorised medicinal products and detect changes to their risk-benefit balance.

b) MEDICAL DEVICES

The Health Board exercises state and administrative supervision over the performance of Medical Devices Act and legislation established on the basis thereof. The Health Board is empowered to enter into premises and facilities, to examine premises and facilities, to take movables into storage, to take samples of products, to question and summon persons, to require presentation of documents, etc., to monitor and evaluate compliance with applicable legislation.

In respect of safety and adverse incidents, manufacturers, distributors and healthcare providers are required to share information with and report adverse events to Health Board. For example, the manufacturer of a medical device shall inform the Health Board of any important changes in the device, of any malfunction or deterioration in the characteristics or performance of a medical device and technical reasons thereof, as well as of any inadequacy in the labelling or instructions.

9. What is the potential range of penalties for noncompliance?    

a) MEDICINES

Upon exercising supervision, the State Agency of Medicines has, by its precept, the right to suspend the sale and dispensing of a medicinal product, terminate the sale or dispensing, ban the advertising, suspend and terminate the clinical study of a medicinal product, demand that the marketing authorization holder or the wholesaler inform the public or health care professionals about risks relating to a medicinal product. If a precept is not complied with, a law enforcement agency has the right to impose penalty payment of up to EUR 9,600.

Non-compliance can (depending on the violation) result in a fine of up to EUR 32,000, suspension or revocation of the marketing authorization of the medicinal product, prohibition of the economic activities, revocation of the activity license.

b) MEDICAL DEVICES

In case of non-conformity of a medical device with the requirements, the Health Board initiates a supervisory procedure with the aim to withdraw such device from the market or to prohibit or restrict the placing on the market and putting into service thereof.

Based on the outcome of inspection of a medical device, the Health Board has, by its precept, the right to require:

• the provision of supplementary information on the use of the device and any dangers related thereto upon placing the device on the market;
• that the manufacturer, authorised representative thereof or person placing the device on the market inform the users of a medical device of dangers related to the use of the medical device and of the possibility to eliminate such danger;
• withdrawal from the market of a medical device which has proven to be dangerous, and prohibit advertising the device and where necessary, require the destruction of the medical device.

If a precept is not complied with, a law enforcement agency has the right to impose penalty payment of up to EUR 3,200.

Non-compliance can (depending on the violation) result in a fine of up to EUR 3,200, and/or prohibition of economic activities.

10. Is there a national healthcare system? If so, how is it administered and funded?             

Estonia’s healthcare system is based on the compulsory solidarity-based insurance (administered by the Estonian Health Insurance Fund) and the general availability of services provided by the private health care providers.

Healthcare is financed from the Estonia’s state budget, but also from rural municipality and city budgets, by the patients and from other sources as direct appropriation. Private health insurance is not widely used.

The management and supervision of health care system and development of health policy is under the scope of the Ministry of Social Affairs and its agencies, such as the State Agency of Medicines, the Health Board and the public independent institution Estonian Health Insurance Fund.

The key task of the Estonian Health Insurance Fund is to be an active purchaser of services whose responsibilities include signing contracts with health care providers, payment for health care services, compensating the cost of medicinal products and medical devices, reimbursement of temporary disability costs and payment of maternity benefits.

11. How does the government (or public) healthcare system function with private sector healthcare?

Estonia has compulsory solidarity-based insurance, private health insurance is not widely used. Healthcare services are provided by the publicly and privately-owned hospitals and by other private healthcare providers. Services are compensated by the Estonian Health Insurance Fund if the healthcare provider has a contract with the Fund.

Estonian Health Insurance Fund takes over from an insured person:

• the payment obligation for healthcare services that are included in the list of healthcare services of the Estonian Health Insurance Fund and have been provided for medical reasons;
• the payment obligation for medicinal products needed for outpatient treatment and included in the list of medicinal products of the Estonian Health Insurance Fund and for the retail sale of special foods to be used for medical reasons;
• the payment obligation for medical equipment which is included in the list of medical equipment of the Estonian Health Insurance Fund.

If the patient is not insured or if the healthcare service is not compensated by the Estonian Health Insurance Fund, the patient has the obligation to pay for it.

12. Are prices of drugs and devices regulated and, if so, how?

a) MEDICINES

Pricing of medicines is regulated by the Medicinal Products Act and its regulations, under which, the Government of the Republic has enacted threshold values for mark-ups in wholesale and retail trade of medicinal products and the procedure for their implementation. The mark-up for different price groups must create equal interest for handling all medicinal products in wholesale and retail trade. The weighted average mark-up in wholesale trade must remain between 7–10% and in retail trade between 21–25%.

In wholesale trade of medicinal products, proportionate mark-ups are applied. The threshold values of mark-ups depend on the purchase price of one original – for example, if the price of one original is up to EUR 1.60, the threshold value for the mark-up is 20%, if the price for one original is over EUR 12.78, the threshold value for the mark-up is 3%. The mark-up in wholesale trade of medicinal products shall not exceed EUR 6.40 per sales packaging.

In retail trade of medicinal products, proportionate and fixed mark-ups are applied. The threshold values of mark-ups depend on the purchase price of one original – for example, if the price of one original is up to EUR 0.64, the threshold value for the mark-up is 20%, if the price for one original is over EUR 12.78, the threshold value for the proportionate mark-up is 0% and for the fixed mark-up EUR 0.38. The mark-up in retail trade of medicinal products shall not exceed EUR 6.40 per sales packaging.

b) MEDICAL DEVICES

Pricing of medical devices is not regulated.

13. How are drugs and devices used by patients paid for? What roles do public and private payers play?

If the patient is insured by the Estonian Health Insurance Fund and the medicine or device is included in the list of medicinal products/medical equipment of the Estonian Health Insurance Fund, the Estonian Health Insurance Fund pays for it in the extent enacted by the applicable legislation. Reimbursement rates for medicinal products are 50%, 75%, 90% and 100% depending on the product. Reimbursement rates for medical devices are 50% and 90% depending on the product. The rest of the price is paid by the patient.

If the patient is not insured, the medicine or device is not included in the list of the Estonian Health Insurance Fund, the patient must pay for the medicine or medical device. Private healthcare insurance is not widely used in Estonia.

14. Who dispenses medicines and devices to patients and how are those dispensers compensated?

Prescription medicines are prescribed by healthcare professionals and prescription medicines and OTC medicines are dispensed to the patients by pharmacies. If the patient is insured by the Estonian Health Insurance Fund and the medicine is included in the list of medicinal products of the Estonian Health Insurance Fund, the medicine is compensated by the Estonian Health Insurance Fund in the extent enacted by the applicable legislation.

Medical devices are dispensed by private companies (distributors of medical devices). Distributors of medical devices are compensated only if they have a contract with the Estonian Health Insurance Fund and if their products are included in the list of medical equipment of the Estonian Health Insurance Fund.

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?

a) MEDICINES

The activity of a pharmacy has to be in accordance with all the requirements enacted by the Medicinal Products Act and its regulations for the enclosed premises, furnishings, technical equipment, personnel, work arrangements and records and the reporting regarding medicinal products.

The pharmacy service can be provided only in pharmacies holding a corresponding activity license and in structural units thereof. To guarantee the quality and safety of pharmacy services, only pharmacists and assistant pharmacists registered by the Heath Board may provide the pharmacy service (including sale of medicines and counselling of patients) in a pharmacy.

Upon dispensing medicines, the patient must be orally notified of the correct and safe ways of usage of the medicine and his or her attention must be drawn to the correct ways of storage of the medicine. The same information shall be recorded on the sales packaging of the medical device or to the sheet attached thereto.

If a prescription does not meet all the requirements applicable under Medicinal Products Act and its regulations, changes are made to the prescription or several medicines are prescribed that are not combinable with each other, the pharmacy must not dispense medicinal products without further investigation.

b) MEDICAL DEVICES

All medical devices must be accompanied by conforming information necessary for identification of the manufacturer and for the safe use of the device for its intended purpose.

Upon the sale of a medical device on the basis of a medical device card (hereinafter card) the buyer shall be notified of the correct and safe use, preservation conditions and maintenance of the medical device, the hazards and undesirable side-effects that may accompany the use of the device. The buyer’s attention shall be drawn to the explanatory notes on the sales packaging of the medical device. The text covering the use of the medical device shall be recorded on the sales packaging of the medical device or to the sheet attached thereto, if necessary. If a sticker is used, it must not conceal important information.

Upon the sale of a medical device on the basis of the card, the seller shall ascertain the suitability of the medical device and ensure the adjustment thereof for the user, if necessary.