Procedures and strategies for pharmaceutical brands: Ukraine
A pharmaceutical product can be marketed in Ukraine only after state registration and issuance of marketing authorisation. The legal framework for the manufacture, distribution and authorisation of pharmaceuticals in Ukraine is established by the Law on Pharmaceuticals 1996, as amended.
Selection, clearance and registration
Relevant national bodies and requirements
A pharmaceutical product can be marketed in Ukraine only after state registration and issuance of marketing authorisation.
An application for marketing authorisation must be filed with the Ministry of Health. The application will then be referred to the State Expert Centre under the Ministry of Health, which is responsible for the examination of registration dossiers and the issuance of decisions that serve as a basis for the grant of marketing authorisations.
The legal framework for the manufacture, distribution and authorisation of pharmaceuticals in Ukraine is established by the Law on Pharmaceuticals 1996, as amended.
The registration procedure is governed by:
- the Resolution on the Enactment of the Procedure for the State Registration (Re-registration) of Pharmaceuticals and the Amounts of Fees for the State Registration (Re-registration) (376/2005), as amended; and
- the Guidelines for Examination of a Pharmaceutical Registration Dossier Submitted for the State Registration (Re-registration) and Examination of Applications for the Registration of Amendments in the Registration Dossier During the Term of a Registration Certificate, enacted by Ministry of Health Decree 426/2005, as amended.
Under the most recent revisions to the Law on Pharmaceuticals, a simplified registration procedure will apply for products which have secured marketing authorisation in countries with strict regulatory authorities and registration systems – including the United States, Canada, Australia, Japan and Switzerland – or via the centralised EU procedure.
Marketing authorisation for pharmaceutical products first registered in Ukraine is limited to five years, but can be extended by application to the Ministry of Health. After the second application, the term of the marketing authorisation is unlimited.
Under Section II(36) of Ministry of Health Decree 426/2005, the name of a pharmaceutical product may be:
- an invented name that is not confusingly similar to a common name (ie, an international non-proprietary name (INN) or common name); or
- a common or scientific name accompanied by a trademark or manufacturer’s name.
The State Register of Pharmaceuticals includes three names for each registered product: a scientific (chemical) name, an INN and a trade name.
The approval system for the names of pharmaceutical products centres on minimising the risks to the life and health of patients that can arise from confusion of medicines. Marketing approval cannot be obtained for pharmaceutical products with names that mislead as to their composition or the effects of treatment.
Confusion with INNs
It is generally accepted that pharmaceutical names constitute a part of medicinal terminology and should help physicians, pharmacists and patients to identify the composition and indications of a pharmaceutical product. Hence, it is not uncommon for pharmaceutical trademarks to be created from descriptive elements, particularly derived from INNs.
Although INNs per se are excluded from protection, trademarks created from altered elements of INNs may be registrable as trademarks. However, stems based on INNs are considered to be weak elements of a mark and trademarks created from INNs confer limited protection. This is illustrated by established court practice, which often refers to a precedential dispute over the likelihood of confusion between the marks ENAP and ENAM. The court rejected the claim, finding no likelihood of confusion between the marks.
Both pharmaceuticals belonged to a group of angiotensin converting enzyme inhibitors and contained enalapril maleate as an active substance. Both names were created based on the INN enalapril, as follows:
- ENAP was a contracted form of ‘enalapril’, composed of its first three and sixth letters; and
- ENAM consisted of the first three letters of the INN enalapril and the first letter of the word ‘maleate’.
Thus, ‘ena-’ was the common stem shared by both trademarks.
The court expert further noted that this stem was present in a number of trade names used for medications in the same group. It found that ‘ena-’ was a weak element in both marks and performed a functional role in helping the relevant public to identify the products. It was the end of each word mark that mattered. Therefore, the marks were found not to be confusingly similar.
Under the Regulation on the State Register of Ukrainian Certificates of Marks for Goods and Services, colours, sounds and shapes can be registered as trademarks. Smell, taste and motion marks are not registrable. Thus, only non-traditional marks that can be represented graphically are registrable, provided that they are sufficiently distinctive to identify the origin of the goods covered.
However, if a three-dimensional (3D) mark represents the shape of the product to which it applies, that shape must not be solely determined by its function. Although no case law has related specifically to shape marks registered for pharmaceutical products, the Ukrainian courts tend to follow a strict approach to the protection of 3D marks, in line with established practice in the European Union. Thus, in Soremartek SA v ZAO Landrin (12/136-9/28) – one of the most prominent cases involving 3D marks – the Supreme Commercial Court found that:
- the round shape of a candy was not inherently distinctive as a figurative mark; and
- the plaintiff had not shown that the mark had acquired sufficient distinctiveness through use in Ukraine by the filing date.
The court further based its position on the relevant provisions of the trademark regulations, which require that applications for non-distinctive, non-registrable signs specifically include “realistic images of products, if an applicant submits such images as the drawing of the mark”.
Thus, if a proposed mark represents the product shape, other elements (eg, words or designs) must be added to it in order to make it registrable.
Parallel imports and repackaging
Ukrainian trademark law does not specifically define ‘exhaustion of rights’ or ‘parallel imports’. The law is thus generally interpreted to provide for the principle of international exhaustion.
However, Article 16 of the Law on the Protection of Rights to Marks for Goods and Services provides an exception to exhaustion when the quality or condition of the goods bearing the trademark concerned has been altered or impaired. Thus, repackaging and relabelling may constitute infringement under certain limited circumstances. There have been few cases of rights holders preventing parallel imports, all of which qualified for the Article 16 exemption from exhaustion.
As a general rule, since the Law on the Protection of Rights to Marks for Goods and Services includes no restrictions on specific territories, it does not regard as IP infringement the import and marketing of authentic goods that have already been placed on the market by the rights holder or with its authorisation anywhere in the world.
Ukrainian border measures were introduced for the purpose of stopping the flow of counterfeit goods and thus do not encompass cases of parallel imports.
In order to be marketed in Ukraine, a pharmaceutical product intended for another market must be repackaged to meet the requirements of the Law on Pharmaceuticals, the Law on the Protection of Consumers’ Rights and the Law on the Fundamental Principle of the State Language Policy in respect of packaging, labelling and patient information leaflets.
An exception to this rule was introduced by Revision Act 269-VIII/2015, which aims to provide timely access to life-saving medicines and medical devices through state tenders involving specialised international organisations. The revisions to Article 12 of the Law on Pharmaceuticals provide for the supply of pharmaceuticals with their original labelling and information leaflets (ie, without the need to have them repackaged to meet the requirements of the Ukrainian market), hence reducing the costs of the products. Each batch of these pharmaceuticals must be accompanied by translated leaflets. This exception will remain in force until March 31 2019.
Anti-counterfeiting and enforcement
The threat posed by counterfeit pharmaceuticals is a major issue in Ukraine, with counterfeits both arriving from abroad and being produced domestically. The most commonly counterfeited products include painkillers, antibiotics and psychotropic substances. Recently, cases of illegal imports and online sales of counterfeit anti-viral medicines have been reported.
Resolving the problem of counterfeit pharmaceuticals is a priority for the government. Ukraine has ratified the MEDICRIME Convention, which entered into force domestically in January 1 2016, and has implemented the relevant provisions into its criminal laws.
The State Pharmaceutical Service is responsible for quality and safety control of pharmaceuticals – specifically, preventing the manufacture and marketing of counterfeit pharmaceuticals through inspections of manufacturers, distributors and pharmacies. The agency cooperates closely with the police and Customs, as well as with international organisations involved in combating pharmaceutical counterfeiting.
Other than facing charges under Article 229 of the Criminal Code (for trademark counterfeiting), parties can be prosecuted under Article 305 (for smuggling counterfeit pharmaceuticals) and Article 321-1 (for the manufacture, purchase, transportation, shipment or storage for the purpose of sale of counterfeit pharmaceuticals), which provide for considerably harsher penalties. Article 321-1 imposes a life sentence in cases of pharmaceutical counterfeiting that results in the death of consumers or other severe consequences.
Where the goods are trademarked, Customs will detain suspected counterfeit goods and notify the rights holder and the declarant, provided that:
- the mark is registered in the Customs Register; or
- Customs has sufficient knowledge of the trademark and its holder.
The rights holder has 10 business days to apply to court for an injunction or submit a written request to Customs for a 10-day extension (if it has valid grounds).
Once the court has issued an injunction, the rights holder must submit a copy of the ruling to Customs in order to extend the term of suspension. If no injunction is issued, Customs will release the goods.
Under Articles 399 and 400 of the Customs Code, if infringement is not established, the detained goods must be cleared and the rights holder must compensate the declarant for the expenses and damages caused by the seizure.
The following legal instruments impose strict and clear restrictions on the advertising of pharmaceuticals:
- the Law on Advertising (270/1996-VR);
- the Law on Protection of Consumers’ Rights (1023-XII/1991);
- the Law on Protection against Unfair Competition (236/1996-VR); and
- the Law on Pharmaceuticals (123/1996-VR).
Over-the-counter (OTC) pharmaceuticals may be advertised, provided that they are approved by the Ministry of Health and not included on the list of products for which advertising is forbidden. A decision on whether to include an OTC pharmaceutical on the banned list is made on its state registration.
The banned list includes:
- prescription-only medicines;
- pharmaceuticals containing narcotic or psychotropic substances and precursors;
- pharmaceuticals indicated for the treatment of:
- women during pregnancy and lactation; or
- children under the age of 12; and
- pharmaceuticals used for the treatment of diseases identified in the relevant regulations.
Under Section 4, Article 21 of the Law on Advertising, ads relating to OTC pharmaceuticals must contain:
- objective information on the product;
- an instruction to:
- consult a medical doctor before using the product; and
- study the instructions for medical use carefully; and
- a warning notice concerning the dangers associated with self-treatment.
Ads may not contain:
- statements suggesting that:
- the drug is particularly efficient against a serious disease;
- consulting a medical doctor is not compulsory; or
- the therapeutic effect is guaranteed;
- laudatory statements;
- comparative advertising;
- references to examples of successful treatment;
- recommendations by medical doctors, scientists, hospitals or organisations;
- medical doctors, other professionals or persons dressed as doctors; or
- information suggesting that the product is:
- dietetic or cosmetic in nature; or
- safe to use due to its natural origin.
An ad must not be misleading as to the product’s origin or efficiency or the existence of patent protection.
Advertising of prescription-only pharmaceuticals is forbidden. Only limited information on prescription drugs (eg, information on the name, characteristics, therapeutic qualities or possible side effects) can be shared. The information may be addressed only to medical doctors, pharmacists and professionals attending medical seminars and conferences.
Although the law does not specifically refer to generic substitution, the practice was recently introduced based on revisions to the regulations for the prescription of pharmaceuticals, further to Ministry of Health Decree 360/2013.
According to Paragraph 1.9 of the decree, a physician can refer only to INNs in prescriptions. Trade names may be indicated only where the active ingredient has not been assigned an INN or the prescribed product is classified as a biosimilar and is subject to reimbursement or other benefits.
A prescription must contain:
- the INN or trade name (in cases mentioned above);
- the names of other components and additives;
- the composition of the product; and
- the dosage form and frequency.
Pharmacists must provide patients with information on all available suitable products so that patients can make their own choices.
The general restrictions on pharmaceutical advertising imposed by law also apply to online advertising. Both domain names and website content must take into account the law governing pharmaceutical advertising.
Ukrainian law allows for the distribution of pharmaceuticals only through licensed pharmacies. Online distribution by any entities other than licensed pharmacies is strictly prohibited by Ministry of Health Decree 723/2011. This applies to both prescription-only and OTC medications.
The general provisions of the E-commerce Law 2015 apply to online sales. However, the right to return goods does not apply to pharmaceutical products, under Article 9 of the Law on the Protection of Consumers’ Rights.
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