The Pharma Legal Handbook: Baltics

Regulatory reform in Lithuania – a comprehensive legal overview. Prepared in association with TGS Baltic, a leading law firm in Lithuania, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for GBP 99.

 

1. Are there proposals for reform or significant change to the healthcare system?

Yes, there are proposals for reforms in the healthcare system.

The following initiatives has been recently approved:

1. Allowing the sale of prescription medicinal products (except for medicinal products containing narcotic-psychotropic substances included in particular lists approved by the Minister of Health). Even though the legal basis for online sale of prescription medicinal products is in place (except for medicinal products containing narcotic-psychotropic substances included in particular lists approved by the Minister of Health), relevant authorities have not been able to prepare online systems which will be invoked in performing such activities. Thus, in practice online sale of prescription medicinal products is currently not available;
2. Allowing pharmacies to perform vaccination (i.e., with inactivaTed vaccines against seasonal influenza, tick-borne encephalitis and also COVID-19 vaccines) and to test population with COVID-19 rapid antigen tests. In order to be able to provide such services pharmacies shall have valid HCI licenses and pharmacists – healthcare professionals’ licenses;
3. “First prescription” rule established in the Law on Pharmacy of the Republic of Lithuania. When the reimbursable medicinal product is prescribed to a patient with an electronic prescription marked “First prescription”, the patient in the pharmacy should be dispensed with a reimbursable medicinal product for which the lowest patient surcharge applies. However, if a patient refuses to purchase a reimbursable medicinal product with the lowest patient surcharge, another reimbursable medicinal product of the same generic name, strength and pharmaceutical form specified in the prescription may be sold given that the patient by reimbursing the patient for the base price of the chosen medicinal product.

   The following initiatives are being considered:

4. To amend the requirements for sales promotion events of medicinal products in HCIs. Major suggested amendments are:
   • regulating the ability to organise online promotional events of medicinal products;
   • creating legal basis for an online database where all of the promotional events shall be registered.

1. The Government also programmed to review and amend the framework for reimbursement of medicinal products and devices to facilitate use of the innovative products. However, specific initiatives or amendments (apart from derogation of “first prescription” rule) have not been made public, yet. 

 

2. When are they likely to come into force?

The initiatives described in items (i) and (ii) above are now in the last stage of approval by the Parliament of the Republic of Lithuania. It is most likely that these initiatives will come into force in late 2018, or early 2019.

It is not yet clear whether the initiatives described in items (iii) and (iv) above would be approved by the Parliament of the Republic of Lithuania.

 

Also from this Legal Handbook

All about patents and  trademarks in Lithuanian pharma. Prepared in association with TGS Baltic, a leading law firm in Lithuania, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for GBP 99.

 

1. What are the basic requirements to obtain patent and trademark protection?

PATENTS:

There are three ways to obtain patent protection in the Republic of Lithuania: 

• National route: by filing an application directly with the State Patent Bureau (hereinafter, the SPB) (under the Patent Law of the Republic of Lithuania); 
• International route: (under the Patent Cooperation Treaty), and; 
• Regional route: (under the European Patent Convention).

 

TRADEMARKS:

There are three ways to get exclusive rights to a trademark in the Republic of Lithuania: 

• National route: by filing applications directly with the SPB (under the Trademark Law of the Republic of Lithuania); 
• International route: whereby the protection provided by the international trademark registration is extended to the Republic of Lithuania (under the Protocol of the Madrid Agreement Concerning the International Registration of Marks), and;
• European Union trademark protection route: whereby any trademark, registered as European Union trademark with the Register of European Union trademarks, is protected in Lithuania (under EU Regulation 2017/1001 of the European Parliament and of the Council of 14 June 2017 on the European Union trade mark).

 

2. What agencies or bodies regulate patents and trademarks?

In Lithuania, patents and trademarks are regulated by the State Patent Bureau of the Republic of Lithuania.

 

3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?

PATENTS:

Patents are available for any inventions in all fields of technology, provided that they are new, involve an inventive step, and are capable of industrial application. Where the object of invention is a method, patent protection is also granted with respect to a product made by such method.

The law establishes the list of what should not be considered as inventions, e.g.:

• discoveries, scientific theories, and mathematical methods;
• designs of products;
• schemes, rules, and methods of games, intellectual or economic activities, as well as programmes for computers, etc.

The law also provides a list when patents should not be granted, e.g. patents are not granted for:

• methods for treatment of the human or animal body by surgery or therapy, except where an object of invention is equipment or materials utilised for such methods;
• inventions, the commercial exploitation of which would be contrary to public interests, principles of morality and humanity, such as processes for cloning human beings or uses of human embryos for industrial or commercial purposes.

 

TRADEMARKS:

A trademark is any sign capable of distinguishing the goods or services of one person from those of other persons and capable of being represented graphically. 

Trademarks may consist only of the following signs:

• words, personal surnames, names, artistic pseudonyms, business names of legal persons, slogans;
• letters, numerals;
• drawings, emblems;
• three-dimensional forms (the shape of products, their packaging or containers);
• colours or combinations of colours, their compositions;
• any combination of signs specified above.

The law provides that a sign may not be recognised as a trademark and must be refused registration in specific cases, e.g.:

• the sign is devoid of any distinctive character;
• the sign has become customary in the current language or in the bona fide and established practices of the trade;
• the sign is of such a nature as to mislead the public, for instance as to the nature, quality or geographical origin of the goods and/or services;
• the sign is contrary to accepted principles of morality or public policy, including ethics of society and humanitarian principles;
• •he sign consists of the official or traditional (abbreviated) state name of Lithuania, of flag or other state heraldic objects or any imitation thereof, etc.;
• it is a sign of high symbolic value, in particular a religious symbol, etc.

4. How can patents and trademarks be revoked?

PATENTS:

Surrender of the patent:

The owner of the patent may surrender the patent by a written declaration to the SPB. The surrender may be limited to one or more claims of the patent. The SPB records the surrender in the Register of Patents and publishes it in the Official Bulletin.

Invalidation of the patent:

On the request of any persons concerned, the court may invalidate a patent on one of the following grounds:

• the invention is not patentable;
• the patent does not disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art;
• the disclosure contained in the patent goes beyond what has been disclosed in the application as filed, or if the patent was granted on a divisional application, which goes beyond what has been disclosed in the initial application as filed;
• the owner of the patent has no right to it.

When a decision of the court to invalidate a patent becomes final, the court sends it to the SPB, which records data on the invalidation in the Register of Patents and publishes it in its Official Bulletin.

 

TRADEMARKS:

Invalidation of trademark registration:

Upon request by any interested person, the registration of a trademark may be invalidated by the court based on the ground that the said trademark does not comply with the Law on Trademarks. When a decision of the court to invalidate a trademark becomes final, the court sends it to the SPB, which removes the trademark from the Register of Trademarks.

Revocation of trademark registration:

Upon the request of any interested party, the court may revoke the registration of a trademark if:

• the trademark has become the common name for goods and/or services for which it is registered, as a result of the treatment of the trademark as a common name by the proprietor or of his inactivity or due to such treatment of the trademark by the others;
• in consequence of the use made of it by the proprietor of the trademark, the trademark is liable to mislead the public, particularly as to the nature, quality or geographical origin of those goods and/or services;
• within a period of five years after the issue of the registration certificate, a genuine use of the trademark has not been started by the proprietor of the trademark in Lithuania.

 

5. Are foreign patents and trademarks recognized and under what circumstances?

European patents granted by the European Patent Office and validated in the Republic of Lithuania are recognised as national patents.

International trademarks are recognised and protected in Lithuania after the notification from the World Intellectual Property Organisation on the extension of the protection of international trademarks in the Republic of Lithuania and the decision of the SPB to grant the protection.

All European Union trademarks registered in the Register of European Union trademarks are also valid in Lithuania.

 

6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?

There are additional barriers for receiving a marketing authorisation for a generic (similar) medicinal product without performing full clinical testing.

Referenced (original) medicinal products are being granted:

• a data exclusivity period of eight years from the initial authorisation;
• additional two years of market exclusivity;
• additional one year in case of certain new indications.

Therefore, the marketing authorisation for a generic (similar) medicinal product can enter into force at the earliest ten years after the grant of the marketing authorisation for the reference (original) medicinal product.

 

7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?

No, there are no restrictions, explicitly stated in laws, on the types of medicines or devices that can be granted patent and trademark protection, except for the general restrictions as provided in question No. 3.

 

8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?

Lithuanian law does not require filing of licence agreement to ensure its validity between the parties, However, if one is willing to be able to use a licence agreement against third parties, a patent or trademark licence agreement with any licensor (both local and foreign) must be duly recorded with the SPB and the data of such agreements must be entered in either the Register of Patents of the Republic of Lithuania or the Register of Trademarks of the Republic of Lithuania.

 

Also from this Legal Handbook

Want to know more about product liability in Lithuanian pharma? Read on! Prepared in association with TGS Baltic, a leading law firm in Lithuania, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for GBP 99.

 

1. What types of liability are recognized in your jurisdiction?

In general, there are three types of liability recognized in the Republic of Lithuania:

• civil;
• criminal;
• administrative.

 

CIVIL LIABILITY:

There are two types of civil liability in the Republic of Lithuania:

• non-contractual (delictual) liability which is not related with contractual relations. Non-contractual liability results from a failure to perform requirements of legal acts which causes damage to the other person;
• contractual liability which results from a failure to perform a contract or from its defective performance where one party of the obligation has the right to claim for compensation of damages or demand payment of a penalty (fine, interest), and the other party is bound to make compensation for damages, or to pay a penalty (fine, interest), caused by the failure to perform the contract, or by a defective performance thereof.

 

CRIMINAL AND ADMINISTRATIVE LIABILITY:

In case the requirements established by applicable laws are breached, a person who is in breach of an obligation may be subject to criminal or administrative liability. Both criminal and administrative liability only to the extent it is provided by the laws. 

 

2. How do these types of liabilities apply to the manufacturers of medicines and devices?

CIVIL LIABILITY:

The applicable type of civil liability depends on the type and nature of the breach, e.g.:

• non-contractual (delictual) liability may arise in cases where a consumer purchases a medicinal product/medical device and it causes damage to the consumer’s health. In this case the liability of the seller/manufacturer arises because of the failure to meet the requirements for the quality and safety of medicinal products established by legal acts;
• contractual liability may derive from the breach of contractual obligations, e.g. in cases where the manufacturer causes damage to the distributor by breaching the provisions of the contract concluded with the distributor.

In case of civil liability, a responsible person may be induced by the court to compensate both direct and indirect damages. In certain cases, the profit made by the responsible party can be acknowledged as damages. In case of contractual liability, there is also a general right to require specific performance.

 

CRIMINAL LIABILITY:

Criminal liability may arise only for serious offences, e.g. manufacturing medicinal products/medical devices in the form of a business or in large amounts without holding a licence; or the sale of medicines which were manufactured without an authorisation for the purpose of handling them and these medicines could have caused a threat to human health or life or have resulted in a person’s death or a serious injury.

Criminal penalties may be imposed in the form of a fine, community service, arrest or imprisonment.

 

ADMINISTRATIVE LIABILITY:

Administrative liability may be imposed for administrative offences, e.g., a violation of regulations and other legal acts governing medical device safety, quality, performance, operation, and marketing; or a violation of medicinal products marketing regulations.

Administrative liability is generally imposed in the form of fines, the amount thereof may vary from EUR 10 up to thousands of euros. 

In addition, economic sanctions and related restrictions (such as suspension or revocation of licences, restriction to supply product to the market, etc.) may be imposed in cases provided by the laws.

 

3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?

In case of damage caused to a third party by the manufacturer or its employees, the manufacturer is held liable. After the manufacturer remedies the third party, it may be able to seek recovery from its employees who are responsible for the damage incurred.

The employee is obliged to compensate for the damage caused to the employer only if the damage was caused due to the non-performance of his/her working duties. There are specific conditions for employees’ liability, e.g., damage should be caused by the employee’s unlawful conduct; there should be a causal link between the unlawful act and the occurrence of damage; the employee should be guilty of causing damage; the occurrence of damage should be related to the employee’s work activities, etc. In addition, under the Labour Code of the Republic of Lithuanian employee’s liability is limited by 3 average salaries under law, except for specifically defined cases (e.g. damage is made by wilful misconduct or criminal offence of employee, moral damages is caused, etc.). 

Administrative penalty may be imposed on the corporate executives and other responsible employees. Administrative liability to a responsible person may arise if the person has been entrusted certain function and have improperly performed them. 

 

4. How can a liability claim be brought?

Generally, a liability claim may be brought before a court by the party who has incurred damage due to an unlawful act of another party (e.g., patients, contractors). In case of health injury, deprivation of life, and other cases specified in legislation, a person is entitled to claim not only pecuniary, but also non-pecuniary damage.

The limitation period for claims for damage, including claims for damage caused by defective production, is 3 years.

Usually, liability claims are civil claims brought before a court by injured parties themselves. However, in certain cases, e.g., where a violation of personal rights and legitimate interests coincides with a violation of the public interest, a prosecutor, in defence of the public interest, can address the court and defend the violated interests of a person.

 

5. What defenses are available?

The manufacturer of an unsafe product may be released from liability for damage caused to the injured person if it proves that one or several of the circumstances took place:

• the unsafe product has not been placed on the market;
• there is sufficient ground to believe that the product was safe when released to the market and its quality deteriorated afterwards;
• at the time when the unsafe product was placed on the market, scientific and technical knowledge was not at a level that would allow determining a potential risk;
• the quality of the product deteriorated due to compliance with mandatory instructions of state institutions; 
• the product was manufactured without intention to release it to the market.

Liability of manufacturer or seller against injured person may be reduced or it may be entirely released from the liability in case the damage was caused by fault of the injured person or a third party that the injured person is responsible for.

Persons who import products from third countries for resale or distribution are liable on the same terms as the manufacturer. 

The manufacturer or seller may be released from administrative liability, if it proves one of the following: 

• the unsafe product has not been placed on the market;
• the product became unsafe as a result of actions of a third party during its improper/unsafe transportation or keeping/storage or because of any other reasons;
• at the time when the unsafe product was placed on the market, scientific and technical knowledge was not at a level that would allow determining a potential risk;
• the consumer used the product in breach of the instructions, precautions, and safety measures, as a result of which he sustained damage;
• unsafe properties of the product are a consequence of force majeure.

Liability may also be limited by certain mitigating circumstances, e.g., the fact that a person who committed an infringement:

• voluntarily prevented the harmful consequences of the infringement;
• cooperated with the responsible authority and/or product safety control bodies during the investigation;
• compensated in good faith for the damage caused to the consumers and/or eliminated the injury.

Also from this Legal Handbook

The ins and out of traditional medicines and OTC products in Lithuania. Prepared in association with TGS Baltic, a leading law firm in Lithuania, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for GBP 99.

 

1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?

Traditional herbal medicinal products are regulated by the Law on Pharmacy of the Republic of Lithuania and its regulations.

Traditional herbal medicinal products may receive a marketing authorisation following a simplified registration procedure.

For traditional herbal medicinal products to be qualified for a simplified registration procedure, they should fulfil specific criteria established by laws, e.g. they must have indications exclusively appropriate to traditional herbal medicinal products which, by virtue of their composition and purpose, are intended and designed for use without the supervision of a medical practitioner; the period of traditional use has already elapsed (herbal medicines have been used for at least 30 years, including at least 15 years within the EU); the data on the traditional use of the medicinal product are sufficient, etc.

The presence of vitamins or minerals in the herbal medicinal product for the safety of which there is well-documented evidence should not prevent the product from being eligible for simplified registration, provided that the action of the vitamins or minerals is ancillary to that of the herbal active ingredients regarding the specified claimed indication(s).

 

2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?

Yes, traditional herbal medicinal products may be advertised directly to the public.

 

3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?

Advertisement of traditional medicinal products must contain mandatory information, established by laws, e.g. the name of a medicinal product, the pharmaceutical form and strength of the medicinal product, a list of information which is essential for the proper use of the medicinal product (therapeutic indications, the method of administration, dosage, special warnings, contra-indications), etc.

In addition, advertising to the general public should not include any restricted information, e.g. the information: 

• that refers to a recommendation by scientists, health professionals or persons who, because of their celebrity, could encourage the consumption of medicinal products; 
• that could, by a description, lead to erroneous self-diagnosis; 
• which refers, in improper, alarming or misleading terms, to claims of recovery; 
• which suggests that the effects of taking the medicine are guaranteed, are unaccompanied by side effects or are better than those of another treatment or medicinal product; 
• suggests that the health of the subject can be enhanced by taking the medicine or affected by not taking the medicine, etc.;
• suggests that the medicinal product is food, cosmetic or other consumer product.

 

4. What are the regulatory requirements for over-the-counter (non-prescription) medications?

Over-the-counter (non-prescription) (OTC) medications are regulated by the Law on Pharmacy of the Republic of Lithuania and its regulations.

OTC products are registered in accordance with the general procedure applied to the registration of all medicinal products. The application and other documents for the registration of OTC products must be submitted to the State Medicines Control Agency.

OTC products may be defined as medicinal products which meet certain criteria established by laws, e.g.:

• they are not likely to present a danger either directly or indirectly, even when used correctly, if utilized without medical supervision;
• they do not contain substances or preparations thereof, the activity and/or adverse reactions of which require further investigation;
• they are not specifically intended for hospital treatment;
• its use may not produce very serious adverse reactions requiring a prescription drawn up as required by a specialist and special supervision throughout the treatment;
• they do not contain a substance classified as a narcotic or a psychotropic substance;
• medicinal products are not likely, if incorrectly used, to present a substantial risk of medicinal abuse, to lead to addiction or be misused for illegal purposes, etc.

 

5. Are there any limitations on locations or channels through which OTC products may be sold?

All OTC products may be sold in pharmacies. Certain OTC products, which are included in the positive list approved by SMCA, may also be sold in retail market places, please see the answer to question 18 on Marketing, manufacturing, packaging and labelling advertising.

 

6. What health, advertising, and marketing claims may be made for OTC products?

Advertisement of OTC medicinal products must contain mandatory information established by laws, e.g. the pharmaceutical form and strength of the medicinal product; a list of information which is essential for the proper use of the medicinal product (therapeutic indications, the method of administration, dosage, special warnings, contra-indications), etc.

Advertising of OTC products to the general public may not include any information indicated in the answer to question No. 3 above.

 

7. Can OTC products be marketed or advertised directly to the public?

Yes, OTC products may be advertised directly to the public.

 

8. What is the mechanism by which a prescription-only product can be converted to an OTC product?

A prescription-only product can be converted to an OTC product by re-registering the medicinal product or by changing the classification thereof according to certain criteria set out in the Law on Pharmacy and the European Commission’s recommendation for the modification of the classification of medicinal products for human use.

 

9. What are the requirements for the importation of either traditional medicines or OTC products?

In order to import either traditional medicines or OTC products from third countries (non-EEA countries), it is necessary to obtain a manufacturing licence.

Medicinal products importable from third countries must be manufactured:

• by the companies duly authorised by the competent authorities of that country to engage in the manufacturing of medicinal products;
• in accordance with the standards of good manufacturing practice (GMP), which are at least equivalent to those laid down by the European Union.

Every batch of medicines imported from third countries must be certified as having been manufactured and tested in accordance with GMP and in conformance with the marketing authorisation before it can be released onto the market in Lithuanian (and the EU). If the medicinal product is manufactured outside the EU and has been imported, it needs to undergo full analytical testing in the EU, unless a mutual recognition agreement is in place between the EU and the exporting country.

 

Also from this Legal Handbook

Introducing the legal situation around marketing, manufacturing, packaging & labelling and advertising of pharmaceuticals in Lithuania. Prepared in association with TGS Baltic, a leading law firm in Lithuania, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for GBP 99.

 

1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?

Possible authorisation procedures for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products are described in the answer to question 3 in the Regulatory, Pricing, and Reimbursement Overview.

 

2. What is the authorization process for the marketing of generic versions of these products?

As for all medicines, generic versions of medicinal products must obtain a marketing authorisation before they can be marketed. In order to receive the marketing authorisation for generic versions of medicinal products in Lithuania, the applicants have to submit an application together with information and documents required by laws to the SMCA. Marketing authorisations are granted after the SMCA has conducted a scientific evaluation of the medicine’s efficacy, safety, and quality.

When authorising generic versions of products, the applicants have to prove that their products are bioequivalent to the reference medicinal product. Since information on the safety and efficacy of an active substance(s) is already available from the reference medicine, the applicants usually do not need to provide the results of clinical testing if the applicant proves that the generic medicine is the medicine that is developed to be the same as the medicine that has already been authorised in any country of the EEA. 

An applicant can only receive the marketing authorisation for generic versions of medicinal products once the period of data exclusivity on the reference medicine has expired. This is usually 10 years from the date of the first authorisation.

 

3. What are the typical fees for marketing approval?

The typical fees for marketing approval are described in the answer to question 4 in the Regulatory, Pricing, and Reimbursement Overview.

 

4. What is the period of authorization and the renewal process?

The maximum term for the SMCA to evaluate documents of a medicinal product during the authorisation process is 210 days from the day when the application with all the required documentation has been submitted.

A marketing authorisation is issued for the initial 5-year period. The period for renewal is described in the answer to question 5 in the Regulatory, Pricing, and Reimbursement Overview.

 

5. What are the requirements, if any, for post-approval pharmacovigilance?

With respect to obligations related to post-approval pharmacovigilance, marketing authorisation holders are obliged to:

• establish a pharmacovigilance system which would ensure the execution of pharmacovigilance tasks of the authorisation holder;
• submit information on adverse reactions of medicinal products to EudraVigilance; 
• register information on adverse effects of medicinal products.

Pharmaceutical and healthcare specialists, healthcare institutions, state institutions, and legal entities carrying out pharmaceutical activities are obliged to inform the SMCA about adverse effects of medicinal products.

The SMCA is obliged to: 

• register information on adverse effects of medicinal products received from patients, pharmaceutical and healthcare specialists, healthcare institutions, state institutions, and legal entities carrying out pharmaceutical activities;
• submit information on adverse effects to EudraVigilance.

 

6. Are foreign marketing authorizations recognized?

Generally, foreign marketing authorisations (i.e. authorisations granted by EEA and/or third countries) are not per se valid in Lithuania. They need to be recognized in Lithuania in accordance with the mutual recognition procedure or decentralized procedure (as described in the answer to question 3 in the Regulatory, Pricing, and Reimbursement Overview).

However, if the medicinal product is authorized via the centralized authorization procedure of the EU (by submitting a single marketing-authorization application to the European Medicines Agency (EMA)), such marketing authorization is recognized both in Lithuania and in other EEA countries.

 

7. Are parallel imports of medicines or devices allowed?

Yes, parallel import of medicines and medical devices is allowed subject to certain requirements established by laws.

Medicinal products may be parallelly imported if both of the following conditions are met:

• a medicinal product is registered in the List of Parallelly Imported Medicinal Products;
• a permit for the parallel import of a medicinal product is issued by the SMCA. 

A permit for parallel import may be issued in respect of a medicinal product which is identical to the medicinal product already registered in the Republic of Lithuania or sufficiently resembling it. A medicinal product can be held sufficiently resembling another medicinal product if it meets the following criteria:

• the same active substance and the same salt of the active substance, the same ester, ether, isomer or mixtures of isomers, complexes or derivatives of an active substance of isomers;
• the same strength;
• the same pharmaceutical form and administration method;
• the same clinical and pharmaceutical properties.

For parallel import of a medical device to Lithuania, it must be marked with a CE mark and an entity willing to import such a medical device has to inform the SHCAA in advance.

 

8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?

In Lithuania, it is prohibited to bribe healthcare specialists, as well as for healthcare specialists to accept bribes. This also means that gifts, irrespectively of their value, cannot be transferred to healthcare specialists. 

Promotional events and scientific congresses held for healthcare specialists are subject to the following restrictions:

• at promotional events of medicinal products, hospitality must not put the main purpose of such an event in the shade and must not extend to others than the participating healthcare specialists. Hospitality in the form of payment of travelling, accommodation and other expenses of healthcare specialists participating in a promotional event is prohibited;
• at professional/scientific congresses, hospitality may only be the secondary purpose of the congress. In congresses, hospitality may be provided or offered only in the form of payment of travelling, accommodation, catering and/or registration expenses of healthcare professionals and/or pharmaceutical specialists.

The visits by medical sale representatives to healthcare institutions with an intent to promote medicinal products to healthcare specialists qualified to prescribe medicinal products are subject to limitations. Medical sale representatives may visit healthcare institutions with an intention to promote medicinal products to healthcare specialists only during the official promotional events organized according to the regulations established by the head of the healthcare institution.

As of 1 January 2020, the values transferred by pharmaceutical companies to the healthcare specialists or healthcare organisations must be declared to the SMCA by providing an annual report once a year (by 30 June).

The pharmaceutical companies in Lithuania are also bound by the Code of Ethics for Pharmaceutical Marketing, adopted by the Innovative Pharma-ceutical Industry Association and the Medicinal Product Manufacturers’ Association – associations of companies engaged in pharmaceutical marketing in Lithuania. Both associations contribute to EFPIA (European Federation of Pharmaceutical Industries and Associations) mission – to promote development of technologies and economics of pharmaceutical industry, helping to put on the market medicines that improve human health around the world. The Code of Ethics for Pharmaceutical Marketing also establishes specific restrictions in relation to marketing of medicinal products, e.g. limitations related to: donations and grants to institutions; interactions with healthcare professionals, healthcare organisations and patient organisations; samples of medicinal products, etc.

 

9. How is the manufacturing of medicines and devices regulated and by which agencies?

The main authority issuing the regulations regarding manufacturing of both medicinal products and medical devices is the Ministry of Health. 

MEDICINAL PRODUCTS:

The requirements for a manufacturing approval are set out mainly in the Law on Pharmacy of the Republic of Lithuania and its regulations on good manufacturing practices (GMP), as well as the EU Guidelines for good manufacturing practices for medicinal products for human and veterinary use (Volume 4). These legal acts regulate and provide guidelines and specific requirements related to the manufacturing of medicines, e.g., requirements for:

• personnel of the manufacturer;
• documentation;
• facility and equipment;
• manufacturing and quality controls;
• packaging and marking;
• etc.

 

MEDICAL DEVICES:

The requirements for manufacturing medical devices are set out mainly in the Law on the Health System of the Republic of Lithuania and its regulations, as well as the European Commission’s guidelines. Legislation provides the following requirements for the manufacturing of medicines, e.g., requirements for:

• facility and equipment;
• documentation;
• enforcement of quality control;
• etc.

SMCA is the authority responsible for applying and enforcing the regulatory framework and performing control functions in relation to medicinal pro-ducts. As for medical devices, SHCAA is responsible for applying and enforcing the regulatory framework and performing control functions.

 

10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the U.S. Food & Drug Administration and/or the European Medicines Agency?

Lithuanian manufacturing requirements for medicines are part of GMPs defined by the European Commission. 

Lithuanian GMPs compatibility with FDA requirements is described in the answer to question 8 in the Regulatory, Pricing, and Reimbursement Overview.

 

11. What is the inspection regime for manufacturing facilities?

The SMCA is empowered to make inspections of premises of manufacturers of medicinal products. 

The SHCAA is empowered to make inspections of premises of manufacturers of medical devices. 

In case of non-compliance, institutions may impose sanctions on manufacturers which may vary from fines (from EUR 30 up to EUR 3,000) to a possible withdrawal of the issued permissions (licences).

 

12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?

No, national competent authorities are responsible for inspecting manufacturing sites located within their territories in the EU. 

A national competent authority may carry out inspections with respect to products on behalf of the EMA under the centralized marketing authorisation procedure.

 

13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?

MEDICINAL PRODUCTS:

The storage and handling of medicines in the wholesale distribution phase must be performed in accordance with the European Commission Guidelines on Good Distribution Practice of medicinal products for human use. The Guidelines establish certain requirements for the transportation and storage of medicines, e.g.:

• wholesale distributors must have suitable and adequate premises, installations and equipment, so as to ensure proper storage and distribution of medicinal products;
• premises should be clean, dry and maintained within acceptable temperature limits;
• etc.

 

According to the Guidelines on Good Pharmacy Practice, the medicinal products must be generally handled and stored in accordance with the storage conditions specified by the manufacturers. There are also specific requirements applied to the storage of medicinal products in pharmacies, e.g.: 

• premises for the storage of medicinal products must be installed and operated in such a way as to guarantee their quality and safety;
• medicinal products must be stored separately from the expired medicinal products or products with the damaged packaging;
• no unused equipment, no food products or personal items of the staff should be stored in the same place as the medicinal products;
• medicinal products must be stored in the packaging of the manufacturer or in a package modified in accordance with the procedure laid down by laws;
• etc.

 

MEDICAL DEVICES:

Medical devices must be handled and stored under the conditions provided by their manufacturer. If the manufacturer does not provide specific conditions for the handling and storage of medical devices, they must be handled and stored in such a way as not to compromise their safety.

 

14. What information must be included in medicine and device labelling? 

MEDICINAL PRODUCTS:

Labelling of medicinal products must comply with the requirements established in the Law on Pharmacy of the Republic of Lithuania and its regulations and must contain certain information required by laws, e.g.:

• a distinctive brand name;
• a pharmaceutical form, drug concentration; a formulation, formula description, dose;
• conservation and storage information;
• precaution and warning legends, including the requirement to store the product out of reach of children;
• authorisation holder’s information, including address;
• etc.

Medicinal products should also contain patient leaflet in the form approved by SMCA. In general, requirements for patient leaflet information stem from EU legal acts. 

The information should be in Lithuanian apart from specific cases specifically provided by the laws 

 

MEDICAL DEVICES:

All medical devices must be accompanied by instructions for use. The instructions for use may be not included in Class I or Class II medical devices if the medical device can be safely used without such instructions. The information provided by the manufacturer on the label and in the instructions for use must be in Lithuanian. 

As for the packaging of medical devices, the information on the manufacturer and its address as well as information which allows patients and healthcare specialists to distinguish the medical device, its serial number, CE marking have to be provided.

 

15. What additional information may be included in labelling and packaging?

The labelling and packaging of both medicinal products and medical devices additionally may contain symbols or pictograms explaining the provided mandatory information. This information cannot contain ads.

As for additional text information, if all required information in the Lithuanian language is included, the same information translated into other languages may be included as well. 

 

16. What items may not be included in labelling and packaging?

Generally, the labelling and packaging of medicinal products and medical devices may not include certain information, e.g.:

• advertising;
• misleading information;
• information which is contrary to good morals;
• information not related to the medicinal product or medical device; 
• etc.

 

17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?           

MEDICINAL PRODUCTS AND MEDICAL DEVICES:

The marketing and advertising of medicinal products and medical devices must satisfy the following general requirements related to advertising:

• the advertisement cannot be misleading;
• the sound and text of the advertisement must be presented in the Lithua-nian language;
• the advertisement must be clearly identifiable. Hidden advertising is prohibited. In cases where certain information may not be unambiguously identified as advertisement, such advertisement must be marked with the word ‘advertisement’;
• the advertisement cannot infringe persons’ data protection rights;
• the advertisement cannot infringe third parties’ intellectual property rights;
• etc.

 

MEDICINAL PRODUCTS:

In addition to the general requirements indicated above, advertisement of medicinal products is subject to special requirements, e.g.:

• non-reimbursable non-prescription medicinal products can only be advertised for the general public;
• it is prohibited to perform such marketing actions which would endorse measureless consumption of medicinal products, for instance, ‘buy one, get one free’, etc.; 
• for healthcare professionals, medicinal products can only be advertised in special sources not accessible to the general public (e.g., websites, articles, journals);
• medicinal products can only be advertised on media sources, this means that advertisement of medicinal products on pens, notes, clocks, calendars, etc. is prohibited; 
• legal acts also establish certain requirements for the content of the advertising (e.g. refer to a recommendation by scientists, health professionals or persons who, because of their celebrity; suggest that the effects of taking the medicine are guaranteed, are unaccompanied by side effects or are better than those of another treatment or medicinal product; present materials oriented specifically to children, etc.).

Also, additional rules on the advertising of medicinal products are established by the Code of Ethics for Pharmaceutical Marketing, adopted by the Innova-tive Pharmaceutical Industry Association and the Pharmaceutical Manufacturers’ Association. For example, the Code of Ethics for Pharmaceutical Marketing provides that promotion of medicinal products must be accurate, balanced, fair, objective and sufficiently complete to enable the recipient to form his or her own opinion of the therapeutic value of the medicinal product concerned; promotion must encourage the rational use of medicinal products; it also provides additional requirements related to transparency of promotion, distribution of promotion, use of quotations, etc.

 

MEDICAL DEVICES:

In the advertisement of medical devices, no patient’s name, image, recommendations of health care institutions, health care professionals or their professional associations can be used.

The advertisement which does not meet the requirements of the Regulation (EU) 2017/745 is prohibited.

 

18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?

There are four ways how medicinal products can be sold/dispensed to the public:

• through physical community, university and charity pharmacies;
• through hospital pharmacies;
• through online pharmacies;
• through retail companies having the right to sell medicinal products.

 

PHYSICAL COMMUNITY, UNIVERSITY AND CHARITY PHARMACIES:

Community pharmacy is the most common type of pharmacies in Lithuania. Community pharmacies are allowed to sell/dispense all types of medicinal products and other pharmacy goods directly to consumers. 

University pharmacy is a structural unit of a university training pharmacists and which performs the functions of a public pharmacy.

Charity pharmacy – a pharmacy that acquires medicinal products and medicinal goods by way of sponsorship and issues them to charity recipients in accordance with the procedure established by the Minister of Health. Charity pharmacy is prohibited from selling medicinal products received as sponsorship.

 

HOSPITAL PHARMACIES:

Hospital pharmacy is a subdivision of a HCI (not all HCIs have hospital pharmacies) which supplies the HCI with medicinal products and (or) other pharmacy goods. Hospital pharmacy is also allowed to sell/dispense reimbursable medicinal products to day-patients undergoing treatment in the health care institution. In this case medicinal products may be prescribed for the provision of day-hospital services at the HCI only.

 

ONLINE PHARMACIES:

Pharmacies (except for hospital pharmacies) established in Lithuania, as well as entities established in any other EEA states having the right to offer medicinal products to the public are allowed to offer medicinal products to the general public through the internet website. Prior to the start of such activity, pharmacy must provide a notification to SMCA about its intent to sell medicinal products online. Legal acts allow to sell online both prescription (except for medicinal products containing narcotic-psychotropic substances included in particular lists approved by the Minister of Health) and non-prescription medicinal products. However, in practice the online sale of prescription medicinal products is not currently possible as the state authorities have not established online systems required for this purpose.

 

RETAIL COMPANIES HAVING THE RIGHT TO SELL MEDICINAL PRODUCTS:

Retail companies holding food business operator’s certificate (i.e. gas stations, grocery stores, etc.) may sell OTC medicinal products to the public. However, such retail companies may sell only a limited spectrum of OTC medicinal products included in a positive list approved by the head of the SMCA. For this purpose, both retail companies and their places of OTC sale must be included in a positive list approved by the head of the SMCA. 

 

MEDICAL DEVICES:

Medical devices can be sold only in their trading places, vending machines, HCIs, and through e-shops.

 

19. What are the restrictions and requirements for electronic marketing and advertising via email, by Internet, social media, and other channels?      

Requirements for the marketing and advertising of medicinal products and medical devices via e-mail, by Internet, social media, etc., are described in the answer to question 17 of this Chapter.

It is important to note that advertising of certain medicinal products (e.g., prescription or reimbursable medicines) to healthcare professionals and pharmaceutical specialists may be performed only through publications and websites included in the positive lists approved by the Minister of Health. Access to these sources must be limited to healthcare professionals only.

 

20. May medicines and devices be advertised or sold directly to consumers?

Only non-prescription homeopathic, herbal, and OTC medicines and medical devices can be advertised directly to consumers. For more details in relation to requirements and limitations on the advertising of medicinal products and medical devices, please see the answer to question 17 of this Chapter.

Medicines and medical devices may be sold directly to consumers subject to certain limitations. For more information on the sale of medicines and medical devices, please see the answer to question 18 of this Chapter.

 

21. How is compliance monitored?

The SMCA strictly monitors and evaluates advertisement of medicinal products, except of misleading advertisement which is a prerogative of the State Consumer Rights Protection Authority.

Monitoring of advertising activities for medical devices is performed by the State Consumer Rights Protection Authority.

 

22. What are the potential penalties for noncompliance?

The sanctions for non-compliance in case of advertising of medicinal products are:

• an administrative fine to a head of a legal entity or other responsible person ranging from EUR 500 up to EUR 3,000 (this sanction may be imposed by the SMCA);
• a fine ranging up to 6 percent of the entity’s last year’s revenue but not more than EUR 200,000 (this sanction may be imposed by the State Consumer Rights Protection Authority);
• suspension/prohibition of dissemination of advertisements (this sanction may be imposed by the SMCA or the State Consumer Rights Protection Authority);
• compelling the advertiser to deny wrongful propositions (this sanction may be imposed by the SMCA).

As regards the non-compliance with the requirements for advertising of medical devices, sanctions are:

• a fine ranging up to 6 percent of the entity’s last year’s revenue but not more than EUR 200,000 (this sanction may be imposed by the State Consumer Rights Protection Authority);
• an administrative fine to a head of a legal entity or other responsible person ranging from EUR 140 up to EUR 560 (this sanction may be imposed by the State Consumer Rights Protection Authority);
• suspension/prohibition of dissemination of advertisements (this sanction may be imposed by the State Consumer Rights Protection Authority).

 

Also from this Legal Handbook

All legal aspects surrounding preclinical and clinical trials in Lithuania answered in this structured guide. Prepared in association with TGS Baltic, a leading law firm in Lithuania, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for GBP 99.

 

1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?    

No, there is no requirement for clinical trials to be conducted in Lithuania as a condition for marketing approval. 

Following the national procedure, clinical trials may be conducted either in Lithuania following the legal requirements of the Law on Pharmacy of the Republic of Lithuania and the Law on Ethics of Biomedical Research of the Republic of Lithuania, or in any country of the EEA in accordance with the requirements of respective legal acts of that country. Clinical trials conducted outside the EEA have to comply with ethical principles equivalent to those set out in the EEA, including adhering to the requirements of International Good Clinical Practice and ethical principles established in the Declaration of Helsinki, developed by the World Medical Association. 

In Lithuania, marketing approval may also be received following the mutual recognition procedure which is based on the recognition of a pre-existing national marketing authorisation by one or more EU countries, or the decentralised procedure, where the application for marketing authorisation is submitted simultaneously in several EU countries, one being chosen as the “Reference Member State”. In such cases clinical trials may be conducted in any country of the EEA.

 

2. How are clinical trials funded?

Clinical trials are generally funded by the sponsor. The sponsor is an individual, company, institution or organisation which takes responsibility for the initiation, management, and setting up the funding of a clinical trial.

 

3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?

A trial protocol is a document that describes the objective(s), design, methodology, statistical considerations and organisation of a trial.

Trial protocols must be scientifically reasoned and prepared in accordance with the requirements of the guidelines for good clinical practice.

For approval of clinical trial for medicinal product, the trial protocol, among other documents of the trial, must be submitted to and approved by the SMCA (competent authority). Clinical trials with respect to medical devices are authorised by SHCAA, which must be submitted relevant documentation. In both cases, the Lithuanian Bioethics Committee also reviews the protocol and expresses an opinion on the trial. In order to receive an approval, the Bioethics Committee must issue a favourable opinion. Other biomedical trials are subject to a permission issued by the Lithuanian Bioethics Committee. 

 

4. What are the requirements for consent by participants in clinical trials?

All participants of clinical trials must sign an Informed Consent of the person to participate in a clinical trial (hereinafter, the Informed Consent). The Informed Consent is documented in writing by filling out the consent form.

The Informed Consent must meet the criteria established by laws, i.e., the Informed Consent must:

1. be given by a person capable of expressing his/her will;
2. be given only after being duly and clearly informed of the objective, plan, applicable methods of the clinical trial, permissions issued by the competent authorities, benefits for the participant, rights of the participant, possible risks and hardships, insurance indemnity in case of damage, the right to revoke the consent and confidentiality guarantees regarding health information;
3. be given freely by the participant or the participant’s legally acceptable representative;
4. meet the comprehensive requirements for content of the consent provided in legal acts.

In very limited cases where the person is in a critical condition or is in another health condition requiring medical attention and subject to compliance of strict provisions prescribed by the law, the consent of the person may be obtained after enrolment of the person into the clinical trial. 

 

5. May participants in clinical trials be compensated?

Yes, the participants in clinical trials may be compensated, subject to limitations. The participants are entitled to compensation only for the expenses incurred and the time spent for participation in the clinical trial. Compensation is paid by the sponsor or by the person authorised by the sponsor. Compensation is paid according to the agreement concluded between the participant and the sponsor of the clinical trial, i.e., when the payment of compensation is included in the Informed Consent form.

 

6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?

Sponsors and principal investigators are liable for any harm (both pecuniary and non-pecuniary) caused to the participants in clinical trials, except for the damage occurring for the reasons not related to the trial or due to wilful misconduct of the participant. 

Sponsors and principal investigators share the liability for any damage suffered by the participant as a result of participation in a clinical trial, unless they agree otherwise. 

Subject to some exceptions provided by the law, sponsors and principal investigators have an obligation to insure their civil liability. The sum of the compulsory civil liability insurance of the sponsor and the principal investigator must be not less than EUR 29,000 for the pecuniary and non-pecuniary damage incurred by a single participant.

 

Also from this Legal Handbook

All about regulation, pricing and reimbursement of drugs in Lithuania. Prepared in association with TGS Baltic, a leading law firm in Lithuania, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for GBP 99.

 

1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?

The authority responsible for applying and enforcing the regulatory framework and performing control functions in relation to drugs and biologicals is the State Medicine Control Agency (hereinafter, SMCA). As for medical devices, the State Health Care Accreditation Agency (hereinafter, SHCAA) is responsible for applying and enforcing the regulatory framework and performing control functions. 

Both institutions act under the supervision of the Ministry of Health.

 

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

The primary legislation for the reimbursement and pricing of drugs, biologicals and medical devices is the Law on Pharmacy of the Republic of Lithuania and the Law on Health Insurance of the Republic of Lithuania and their regulations. The legislation for the authorisation of medicinal products is the Law on Pharmacy of the Republic of Lithuania and its regulations.

The primary legislation for the authorisation of medical devices is the Law on the Health System of the Republic of Lithuania, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (hereinafter, Regulation (EU) 2017/745), Technical Regulation on the Safety of In Vitro Diagnostic Medical Devices approved by the order of the Minister of Health of the Republic of Lithuania No. 679, passed 29 December 2001 (In Vitro Local Regulation) and other related regulations, approved by the Minister of Health of the Republic of Lithuania.

Generally, in Lithuania wholesale and retail mark-ups of medicinal products are regulated by the Minister of Health and the Government:

• as for the reimbursable medicinal products wholesale and retail mark-ups are regulated by the Minister of Health;
• as for non-reimbursable medicinal products wholesale and retail mark-ups are regulated by the Government.

Wholesale and retail mark-ups of medicinal devices are regulated only with respect to reimbursable medical devices. Mark-ups for reimbursable medical devices are regulated by the Minister of Health. Prices for non-reimbursable medical devices are not regulated.

 

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

A. MEDICINAL PRODUCTS

There are several medicinal product authorisation procedures in the Republic of Lithuania. 

National procedure

In case an entity seeks to authorise a medicinal product, which has not been authorised in any other state of the European Economic Area (hereinafter, EEA), in order to market it only in the Lithuanian market, it must submit an application to the SMCA.

The timeframe of the authorisation process on medicinal products should not exceed 210 days from the day when the application with all the required documentation was submitted.

During the authorisation processes, applicants must prove:

• as for new molecules and biologicals – quality, safety and efficacy of the medicinal product;
• as for generics – bioequivalence with the reference medicinal product.

 

Decentralized procedure

In case an entity seeks to authorise a medicinal product, which has not been authorised in any other country of the EEA, in order to market it in several EEA countries, including Lithuania, it must submit to the SMCA an application with the dossier which has been provided to the national authorities of other Member States.

 

Mutual recognition procedure

In case an entity seeks to authorise in Lithuania a medicinal product, which has already been authorised in at least one Member State on a national basis (Reference Member State), it must submit the application with the dossier to the SMCA (Concerned Member State). If the whole mutual recognition process is successful, the SMCA will mutually recognise the marketing authorisation of the Reference Member State, permitting the marketing of that medicinal product in Lithuania as well.

Both mutual recognition and decentralized procedures are based on recognition by national authorities of a first assessment performed by one Member State. In order to authorise medicinal products, an identical application for marketing authorisation has to be submitted simultaneously to the competent authorities of the Reference Member State and of the Concerned Member States. The difference of both procedures lies in that the mutual recognition procedure applies to medicinal products which have not received a marketing authorisation at the time of application, while the decentralized procedure applies to medicinal products which already received marketing authorisation in one or several Member States at the time of application.

 

EU Centralised Procedure 

In addition to the authorisation procedures indicated above, medicinal products can also be authorised with a single application in all EEA countries by the European Commission through the Centralized Procedure.

 

B. MEDICAL DEVICES

Only medical devices complying with the requirements of the Regulation (EU) 2017/745 or the In Vitro Local Regulation may be placed on the market of the Republic of Lithuania. Specific requirements vary depending on the type of the medical device (e.g., classes I, II, III, in vitro, etc.).

Manufacturers of medical devices (If the manufacturer of the medical device is not established in a Member State of the EEA, the mandatory data shall be submitted by the manufacturer’s authorised representative established in the Republic of Lithuania), persons assembling and/or sterilizing procedural packs and/or systems established in the Republic of Lithuania before placing them on the market on their own behalf have to register them with the SHCAA. The following medical devices have to be registered (i.e., all of the following medical devices have to be registered with the SHCAA until the European database on medical devices (EUDAMED) becomes functional):

• custom-made medical devices;
• custom-made active implantable medical devices;
• manufactured in vitro diagnostic medical devices;
• manufactured medical devices for performance evaluation;
• manufactured Class I medical devices;
• systems and / or procedure packs;
• sterilizable systems and / or procedure packs.

Manufacturers of medical devices, authorised representatives of medical device manufacturers, importers of medical devices and distributors of medical devices placing on the market of the Republic of Lithuania class IIA, IIB, III and custom-made active implantable medical devices in accordance with the rules specified in Regulation (EU) 2017/745 must submit data on the address of their registered offices and data on medical devices placed on the market of the Republic of Lithuania to the SHCAA.

 

 

4. What are the approximate fees for each authorization?

A. MEDICINAL PRODUCTS

State fees for authorisation of medicinal products depend on the type of the authorisation procedure. 

National procedure

As for national authorisation procedure, an approximate fee is EUR 5,413. 

 

Decentralized and mutual recognition procedures

For decentralized or mutual recognition procedures, when the Republic of Lithuania participates as a Concerned Member State, i.e., a Member State which recognizes the authorisation of another Member State, an approximate fee is EUR 788. 

In case the Republic of Lithuania participates in the authorisation process as a Reference Member State, i.e., a Member State which evaluates the marketing authorisation application dossier and prepares the assessment report on behalf of the Concerned Member States, the following approximate fees apply:

• decentralized procedure – EUR 11,961;
• mutual recognition procedure – EUR 6,691.

B. MEDICAL DEVICES

A state fee is charged for the registration of medical devices supplied to the market. The registration fee for one medical device is EUR 38.

 

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

TERM OF VALIDITY

A national marketing authorisation of medicinal products is valid for 5 years. After this period, the holder of a marketing authorisation of a medicinal product may renew the authorisation of the medicinal product. Generally, a renewed marketing authorisation is valid for an indefinite period, however, the SMCA may decide on the need for a renewal after another 5 years from the first renewal procedure.

In case an authorised medicinal product is not marketed within 3 years from the moment of authorisation, the authorisation becomes invalid. 

For medical devices, registration is valid indefinitely.

 

RENEWAL OF A MARKETING AUTHORIZATION

In order to renew a marketing authorisation for a medicinal product, authorisation holders must submit an application for the renewal of a marketing authorisation together with other required documents no later than 9 months before the expiry date of the initial authorisation. The renewal process cannot take more than 180 days from the date of the application for the renewal of a marketing authorisation.

The applicants must submit a consolidated file containing information on the quality, safety, and efficacy of the product, etc., together with the application for the renewal of a marketing authorisation. The file and the application shall be submitted to the SMCA.

The SMCA performs the re-evaluation of a benefit/risk balance based on a consolidated version of the file and any relevant new information. The renewal of a marketing authorisation is issued only if the benefit/risk balance is positive.

Once a marketing authorisation has been renewed and no further renewal is considered necessary, the marketing authorisation will be indefinite. However, the SMCA may decide on the need for a renewal after another 5 years from the first renewal procedure. The decision on whether to renew a marketing authorisation with unlimited validity or to require an additional 5-year renewal is taken on the basis of the criteria described by laws, e.g., based on pharmacovigilance data, the number of patients treated by the medicinal product, etc.

For medical devices, no registration renewal is required.

 

6. How does the authorization process differ between brand-name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?        

DIFFERENCES OF THE AUTHORIZATION PROCESS BETWEEN BRAND-NAME AND GENERIC MEDICINAL PRODUCTS:

A person who intends to authorise a brand name medicinal product is obliged to submit to the SMCA an application together with the results of pharmaceutical (physico-chemical, biological or microbiological), pre-clinical (toxicological and pharmacological) clinical trials and other documents/information required by laws. 

As for generic medicinal products, it is not obligatory to submit the results of pre-clinical and clinical trials. However, for generic (similar) medicinal products, marketing authorisations without performing full clinical testing may be received only after the market exclusivity period of ten years from the initial authorisation of the reference (original) medicinal product has expired.

 

DIFFERENCES FOR LOCAL MANUFACTURERS VERSUS FOREIGN-OWNED MANUFACTURERS:

In Lithuania, there are no differences in the authorisation process applied to the medicinal products of local manufacturers versus manufacturers established in the EEA. 

 

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

Combination products can be classified either as drugs or as medical devices. Depending on the nature of the combination product, the authorisation institution may be either the SMCA or the SHCAA.

 

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?

MONITORING OF COMPLIANCE:

There is a permanent pharmacovigilance system in Lithuania, which is administered by the SMCA. This system is based on the information on adverse effects submitted by healthcare professionals, pharmacists, patients and other persons (e.g., other state institutions, etc.). The SMCA and medicinal products authorisation holders submit information on adverse effects of medicinal products to EudraVigilance, a centralized European database of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the EEA.

 

COMPARABILITY WITH THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) OR THE EUROPEAN MEDICINES AGENCY EXPECTATIONS AND REQUIREMENTS:

The Lithuanian regulatory regime is compliant with the EU regulations and directives. Lithuanian regulatory institutions refer to the European Medicines Agency’s Guidelines and other explanatory documents.

The EU and the United States of America (the U.S.) have entered into a mutual recognition agreement on GMP inspections.

In general, the agreement facilitates the exchange of official GMPs documents between the EU and the US authorities and reliance on the factual findings in such documents. The agreement seeks to facilitate trade and benefit public health by allowing the EU and the US to leverage and to reallocate their inspection resources, including by avoiding duplication of inspections, so as to improve oversight of manufacturing facilities and better address quality risk and prevent adverse health consequences.

The SMCA of the Republic of Lithuania has been recognised in accordance with the agreement on 1 June 2018.

 

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

The SMCA and the SHCAA can perform ordinary and non-ordinary audits of the entities engaged in activities related to medicinal products/medical devices. 

As for medicinal products, in case of non-compliance the SMCA can impose the following sanctions:

• suspension/revocation of the marketing authorisation; 
• suspension/revocation of the retail company’s right to sell medicinal products, pharmacy activity license, wholesale distribution license and manufacturing licence;
• an administrative fine to the head of a legal entity or other responsible person, ranging from EUR 30 up to EUR 4,300;
• cancelation and/or removal of medicinal products from the market.

In some particular cases (e.g., non-compliance with the conditions of sale (dispensing) of medicinal products to the general public, etc.) even the forfeiture of medicinal products may be imposed. 

As for medical devices, in case of non-compliance the SHCAA can impose following sanctions:

• suspension for the placing on the market and/or distribution and/or use of medical devices;
• cancelation and/or removal of medical devices from the market;
• prohibition of the placing on the market, distribution, and use of medical devices;
• a fine, ranging from EUR 30 up to EUR 1,500.

The severity of the sanction may depend on the gravity of the infringement, repeatability of the infringement, damage caused to the patients, etc.

 

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

The Lithuanian national healthcare system is mainly funded from the Compulsory Health Insurance Fund budget (CHIF). The scheme is based on compulsory, largely employment-based contributions, administered by the NHIF. National healthcare system is structured to cover the entire population resident in Lithuania (however residents failing to pay compulsory contributions are not insured). 

The Ministry of Health is responsible for general supervision of the entire health care system. It also governs the NHIF, which is subordinated to the Ministry.

 

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

The majority of Lithuanian health care institutions (HCIs) are non-profit-making public HCIs, mostly financed by the funds from CHIF. 

In addition to public health care system, the private sector provides mostly outpatient health care services which are paid by the patients themselves (out-of-pocket payments), territorial health insurance funds or private insurers. The private healthcare sector is very limited in providing inpatient care but plays a substantial role in other areas such as primary care, cosmetic surgery, and dental care.

Based on the main source of financing, 3 types of HCIs may be distinguished:

• public HCIs (financed mainly from the CHIF and/or State or municipal budget allocations), which provide most of their services free of charge for the patients insured by compulsory national health insurance;
• private HCIs (financed basically from private funds (patients and private insurance)), which provide mainly paid services for the patients;
• mixed-type HCIs, i.e., private HCIs which conclude agreements with the NHIF or THIFs in order to provide certain services for the patients insured by compulsory l health insurance free of charge. The remaining services are paid.

 

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

Prices are regulated for the following products and devices:

• non-reimbursable medicinal products;
• reimbursable medicinal products and medical devices. 

NON-REIMBURSABLE MEDICINAL PRODUCTS AND MEDICAL DEVICES:

As for non-reimbursable medicinal products, marketing authorisation holders (MAHs), parallel import permit holders (PIPHs) or their local represen-
tatives (LOCs) have to declare to the Ministry of Health the price at which a non-reimbursable medicinal product will be distributed in Lithuania (the Declared Price). The Declared Price is used as the basis from which maxi-mum allowed wholesale and retail prices of non-reimbursable medicinal product are calculated by adding maximum wholesale and retail mark-ups set by the Government, and VAT (if applicable). However, the final maximum markups and maximum price is determined taking into account the actual price at which the product is sold to wholesaler and/or retailer. In case of multiple wholesalers / retailers in a supply chain, the maximums mark-up is shared between them. 

Prices of non-reimbursable medical devices are not regulated, they are sold at a market price.

 

REIMBURSABLE MEDICINAL PRODUCTS AND MEDICAL DEVICES:

With respect to the reimbursable medicinal products, MAHs, PIPHs, parallel distributors or their LOCs, manufacturers of medical devices or their LOCs have to submit the price applied for Lithuania (Applied Price for Lithuania) to the NHIF. The Applied Prices for Lithuania are used as the basis for calculating the end prices of reimbursable medicinal products and reimbursable medical devices (i.e., by adding to it fixed (maximum) wholesale and retail mark-ups, established by the Minister of Health, and VAT (if applicable)).

As for reimbursable medicinal products and medical devices, the prices are established in the Pricelist of Reimbursed Medicinal Products and the Pricelist of Reimbursed Medical Devices, approved by the Minister of Health of the Republic of Lithuania.

 

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

OUTPATIENT SECTOR:

Payment for medicinal products/medical devices in the outpatient sector depends on whether such products/medical devices are reimbursable or non-reimbursable.

A reimbursable medicinal product or medical device may be fully or partially reimbursed. The level of reimbursement of such products depends on the terms of reimbursement established for a particular product, the price of a particular medicinal product/medical device, on the social status of the patient (e.g., pensioners may be provided different reimbursement terms compared with other citizens) and the diseases that the product is prescribed for. 

In case a medicinal product/medical device is only reimbursed partially, the patient has to pay a co-payment.

 

INPATIENT SECTOR: 

As for the inpatient sector, expenses for medicinal products and medical devices may be covered from public funds, provided that:

• a patient is covered by compulsory health insurance;
• healthcare services are provided by the healthcare institution which has concluded a compensation agreement with the territorial health insurance fund;
• provided healthcare services are included in the list of healthcare services which costs are reimbursed by the state;
• to have a written order from a (e. g., family) doctor to see a specialist or get certain medical services.

In other cases, except the situations where emergency assistance (first-aid) is provided to the patient, patients have to pay for the medicinal products or medical devices provided.

 

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

As for the outpatient sector, medicinal products are dispensed by pharmacies. In addition, retail companies having the right to sell medicinal products are allowed to dispense a limited list of medicinal products as approved by SMCA (no prescription or reimbursed products). Medical devices may be dispensed by healthcare institutions and sellers (i.e., pharmacies, shops, vending machines, etc.).

As for the inpatient sector, medicinal products and medical devices may be dispensed by healthcare institutions.

As far as the compensation issue is concerned, please see the answers to questions 10 and 11 of this Chapter.

 

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?

In case of medicinal products, pharmacists and pharmacy technicians who dispense medicinal products to patients are obliged to:

• provide the patient with information on the use of medicinal products;
• dispense medicinal products according to legal requirements only;
• etc.

Pharmacists are also allowed to provide pharmaceutical care services and to perform vaccination and COVID-19 rapid antigen testing within the premises of the pharmacy (in this case pharmacies shall have a valid HCI license and pharmacists shall have valid healthcare professionals’ licenses).

In addition, in case of a reimbursable or prescription medicinal product or reimbursable medical device, patients must also be informed about other similar products/medical devices.

Cashiers of the retail companies having the right to sell medicinal products can sell OTC medicinal products included in the list approved the SMCA. There are no pharma-related qualification requirements provided for such cashiers in local legal acts.

Also from this Legal Handbook

With the end of the Lithuanian Parliament’s Spring Session, a period of neverending discussions and misunderstandings has ended too, as the Parliament and the Ministry of Health have finally adopted a new medicines reimbursement system, writes Ruta Pumputienė.

 

Lithuanian Ministry of Health deserves compliments for getting involved in the dialogue around the new reimbursement system itself, as well as involving all stakeholders. They have also taken into account the comments of doctors, patients, and industry’s representatives. Finally, they have eliminated a much-debated EUR 30,000 medicine value benchmark from the draft law.

 

With the new criteria come positive changes. Firstly, it will hopefully help diminish discrimination towards oncological medicines. Secondly, a step towards a flexible financial benchmark to reimburse medicines has been taken. Nevertheless, there is still plenty of room to improve – especially in terms of including innovative oncological medicines into the reimbursable medicines lists.

 

Challenges for innovative oncological medicines remain

Unfortunately, the requirements for innovative oncological medicines remain overly strict and critical, which does not reflect good clinical practice.

 

For example, when deciding on oncological medicines’ reimbursement, the main criteria is the so-called “survival rate.” As the innovative oncological medicines are getting more and more effective, this seems to be outdated. The most important criteria nowadays should be the elimination of cancerous cells and stopping disease’s progress, as well as the improvement of quality of life.

 

Moreover,  although the medicines show effectiveness in a dozen months already, sometimes it takes up to 10 years to evaluate the aforementioned “survival rate” criteria. Only after proving the “survival rate” criteria the medicine can be included in the reimbursed medicines list. Patients suffer because of this prolonged period of reimbursement procedure the most.

 

The right direction but a lack of flexibility

In general, the direction in which Lithuanian decision-makers are going is correct, especially in terms of facilitating the dialogue and listening to the arguments of all involved stakeholders.

 

All stakeholders – the evaluators of medicines reimbursement, industry representatives, as well as doctors are interested in helping patients get well as soon as possible. This can not be achieved without a fast-reacting, non-bureaucratic medicines’ reimbursement system, which focuses on facts and promotes innovation. Lithuania could, for example, follow the good practice of some European countries who are splitting the reimbursement procedure’s costs with the industry if they see that the new medicines’ results are worth it.

 

The world, science, and innovations are quickly moving forward, and decision-makers have to move forward with them. Only this way Lithuanian patients will be provided with an opportunity to get access to the newest, most effective medicines, and it will be a few, rather than ten years until these medicines reach Lithuanian patients. Transparent, clear, and flexible reimbursement solutions would be beneficial to the state on a few very different levels since the costs allocated to health are investments rather than costs because healthy people are the basis for a prosperous country.

Also from this Legal Handbook

Ruta Pumputiene examines recent regulatory reform in Lithuania, as the Baltic nation attempts to introduce a holistic HTA mechanism for the evaluation of what to include on the country’s reimbursable medicines list.

 

It is not yet clear whether the new procedure will complicate and damage Lithuanian patients’ access to the newest and most effective medicines

The Spring Session Agenda of Seimas [the Lithuanian parliament – Ed.] includes long-promised changes, namely amendments to the Pharmaceutical Law, which will legitimize the system of inclusion of medicines in the reimbursable medicines’ lists. After adopting the amendments at Parliament, the Minister of Health will still have to adopt a new order which will detail this new system. Manufacturers, doctors, and patients are eagerly awaiting it. It is not yet clear whether the new procedure will complicate and damage Lithuanian patients’ access to the newest and most effective medicines.

 

These changes will provide the basis for the introduction of an innovative medicines’ evaluation mechanism, the so-called Health Technology Assessment (HTA), which puts the focus not only on a medicine’s price but also on its value in relation to its price and other direct costs. The evaluation of cost-effectiveness is an important element of the new medicine assessment scheme because the costs of treatment will be compared to the patient’s additional qualitative years of life, i.e. cost-effectiveness will be measured as the additional cost per quality-adjusted life year (QALY) gained.

 

The purpose of HTA is to ensure the efficient use of costs, i.e., to determine whether the added therapeutic value of the new medicine is proportional to the overhead costs. A more effective assessment of reimbursable medicines should ensure the more efficient use of both the Compulsory Health Insurance Fund’s (CHIF) and State Social Insurance Fund’s (Sodra’s) budget.

 

Unfortunately, although the introduction of HTA to the medicine evaluation system is positive, Lithuanian policymakers have left ambiguities, loopholes, and other issues within the legislation. These raise reasonable doubts about the prospects of proper implementation of the much-anticipated and necessary system.

 

Unrepresented interests of the patients: uncertainty about the ICER threshold and ‘disease burden’

It is commendable that the comments by pharmaceutical manufacturers, healthcare professionals, and patient associations were taken into account when preparing the Health Ministry’s draft order, which aims to introduce HTA.

 

One of the comments was that, in cases of serious illnesses, the objective of comparing a treatment’s cost-effectiveness with the incremental cost-effectiveness ratio (ICER) threshold should not be limited to one specific amount for all patients and all diseases, as it would merely prevent new medicines, especially for oncological and rare diseases, from entering the reimbursable medicines list. In response to this, the authors of the project have introduced a new indicator – ‘disease burden’, i.e. the severity of underlying illness – to the assessment system. This indicator would theoretically allow for an objective assessment and comparison of the specific medicine’s impact on different diseases and conditions, as well as life expectancy and quality.

 

However, as this is an entirely new concept, it would be worthwhile establishing the procedure for calculating and applying this indicator, either by a separate Minister’s Order or by making it an addition to the same order. Until a more concise methodology is prepared, the draft order must include a provision stating that the defined incremental cost-effectiveness ratio (ICER) threshold shall not be applicable in such cases (or otherwise, proportionally increased depending on the burden of the disease). Unfortunately, such clarity is not yet present.

 

Otherwise, the barrier mentioned above – the incremental cost-effectiveness ratio (ICER) threshold (the total, and the only one amount in the draft order, is indicated as EUR 30,000 per QALY gained) will automatically prevent Lithuanian patients’ access to a large proportion of medicines that do not comply with this threshold. It is regrettable that this has not been taken into account from the outset, as there were no attempts to evaluate the new mechanism’s effect on patients’ access to certain medicines.

 

A significant increase in administrative and financial burden: solutions exist

The authors of the project have failed to identify that the administrative and financial burden for the manufacturers will increase significantly

Unfortunately, the Pharmaceutical Law’s explanatory memorandum indicates that no negative consequences are foreseen after the adoption of the legislation.

 

The authors of the project have failed to identify that the administrative and financial burden for the manufacturers will increase significantly. Not only will there be a substantial increase in the amount of information that must be provided along with the application, but the direct costs of preparing the application will also increase. Assuming there will be about 50 manufacturers’ applications per year, the total financial burden alone will amount to around EUR 900,000 (the cost of preparing one application amounts to about EUR 14,000, and a further EUR 4,000 is paid for the evaluation of the application).

 

At least a slight reduction of the administrative burden is possible. It can be done, firstly, by eliminating the unnecessary paperwork (e.g. by waiving the requirement to submit a full application if the proposed changes to the prescription are of an administrative nature and do not affect the budget of the CHIF). Secondly, the process can be made easier by waiving the requirement to provide information on the reimbursement of medicines in other countries, because such information does not affect decision-making and may be misleading if not updated regularly. Thirdly, it must be stated clearly which application parts must be filled out and which are optional. Finally, it is necessary to indicate which parts of the application can be filled out in English, thus avoiding time-consuming Lithuanian translations.

 

It is also necessary to improve the legislation itself to make it more precise and understandable. Ambiguous wording and duplicated points must be removed. The terminology, such as “treatment guidelines,” etc. should be explained in detail. The Pharmaceutical Law itself must regulate the essential principles of the medicines reimbursement system, including one of the most important criteria for transparency: the recordings of the Medicines Reimbursement Commission’s meetings, the obligation for the commission to make objective and reasonable decisions, and the need to define the frequency of the meetings themselves.

 

Involving patients and healthcare professional organizations, no new medicine assessment system can be sustainable without the proactive involvement of patients and/or competent healthcare professionals. This should be ensured not only by publishing information about the applications in question, but also by informing relevant organizations proactively by e-mail or similar means. Feedback is important too. After receiving these organizations’ opinions and observations, it should be mandatory to follow up on the progress of their proposals and adopted decisions.

 

Conclusion: do not damage

It seems that, sometimes, it is forgotten that the procedure for reimbursing medicines and the decision-making process is not a race, nor a fight between the decision-makers and drug manufacturers

The inclusion of medicines in the reimbursable medicines list has always been a Kafkaesque process: long-lasting, costly, and rarely bringing benefit to the patients as quickly as needed. It is commendable that the Ministry aims to improve this process by amending the Pharmaceutical Law and the future Minister’s order. However, some details still raise doubts, not only among pharmaceutical manufacturers and their representatives, but also among patients and healthcare professionals.

 

It seems that, sometimes, it is forgotten that the procedure for reimbursing medicines and the decision-making process is not a race, nor a fight between the decision-makers and drug manufacturers. This is, first and foremost, a process that must serve the interests of patients. It should ensure that the medicines needed by Lithuanian patients are reimbursed quickly and that budget funds are being saved.

 

This cannot be done without the involvement of all the stakeholders in the decision-making process, without ensuring maximum transparency, without removing the unnecessary paperwork and administrative burdens, and without removing unjustified economic barriers to the reimbursement of medicines for oncological and rare diseases.