PHARMACEUTICALS AND HEALTHCARE

In terms of continuously evolving market and fast developing healthcare system of the country the pharmaceuticals and healthcare companies encounter numerous challenges such as adherence to government regulations, consideration of local and international tax and customs regulations, and all types of commercial issues including competition matters, parallel importation practice, disputes over intellectual property, anti-monopoly and other key issues.

We provide integrated legal advice to a range of companies in Pharmaceuticals & Healthcare sector in Kazakhstan and CIS countries.

Our knowledge of local business environment and clear understanding of our clients’ business and legal needs help us to add real value to our clients at all stages of projects, providing them with practicable and legally robust solutions.

Our services include:

Ethical promotion of the medicines Protection of IP rights Legal support on pricing Competition and compliance Localization of drugs manufacturing Support with planning and negotiations on investments to

Kazakhstan Counselling on private-public partnership structuring Legal due diligence Data protection Employment relations Anti-corruption matters Taxation Customs regulations Representation in courts

Our Experience

ADVERTISING, PROMOTION AND SALES OF MEDICINES AND MEDICAL EQUIPMENT

Advising a global pharmaceutical company on interaction with pharmacies and healthcare professionals in terms of motivation and applicable restrictions

Advising on advertising of medicines and product branding

Developing detailed marketing guidelines for a multinational pharmaceutical company and advising on legal and tax regulation of the pharmaceutical activity in Kazakhstan

Advising on advertising and free distribution of samples of prescription drugs

Review of marketing materials for compliance with local regulations

Advising on import and distribution of medicines aimed to obtain clinical practice with the patients

Drafting model agency agreements for use in Kazakhstan and other CIS countries

Advising on import of non-registered medicines to Kazakhstan

Advising on one-time imports of medical equipment not registered in Kazakhstan

Advising on entering into contracts with pharmacies

Advising a large international company on matters related to distribution and advertising of medical devices

Advising on possibility of distributing an information about non-registered medicines during events for healthcare professionals

Advising one of the largest manufacturers of cosmetics, hygiene products and medical equipment on the labelling of medical devices

Advising a manufacturer of medical equipment on consumer rights protection matters

REGISTRATION AND PERMITS

Advising on and providing legal assistance with registration of medicines in Kazakhstan

Advising a producer of diagnostic medical equipment on registration of medical equipment

Representing an international pharmaceutical company in the court case on appeal over a government agency's decision to refuse the registration of the medicine

Advising a large international company on inclusion of the products in the national register of medicines of the Republic of Kazakhstan

Analysis of warehouses lease agreement for storing medical equipment

Advising on requirements for obtaining a pharmaceutical business license

Representing client in communications with the government agency to obtain official confirmation on the absence of requirement for registration of a medical substance produced in accordance with Good Manufacturing Practice

PRICING

Advising on interpretation and application of pricing rules and analysis of potential effects

Providing an overview of the pricing regulations in Kazakhstan, assessing the regulatory compliance of the decisions and actions of an international pharmaceutical company, developing recommendations to reduce potential risks

Advising a pharmaceutical company in the course of anticorruption investigation against third parties

Advising on the lists of maximum purchase prices on medicines for the government procurement

LOCAL MANUFACTURING OF MEDICINES

Analysis of investment preferences granted to foreign investors in the pharmaceutical sector

Analysis of phased local production of medicines to qualify for the “local” status for the medicines

Assessment of potential risks of manufacturing medicines locally and developing appropriate proposals to amend healthcare legislation

Analysis of prospects and risks of local manufacturing of medicines associated with Kazakhstan's membership in the Eurasian Economic Union

Attending negotiations with the ministries and government agencies on manufacturing medicines in Kazakhstan and possibility of granting investment incentives

INTELLECTUAL PROPERTY

Advising an international pharmaceutical company on violations of intellectual property rights by a local pharmaceutical company applied for long-term government procurement contract

Advising on transaction between pharmaceutical companies regarding the transfer of rights on a pharmaceutical product

Advising on re-registration of trademarks in Kazakhstan and assistance during the intellectual property examination in Kazakhstan

Advising on the alignment of local regulations with the TRIPS Agreement mandatory for all member states of the WTO

Drafting and analysis of copyright agreements with the healthcare experts on transfer of copyright to the research results

Drafting and registration on assignment contracts and licensing agreements for the use of trademarks by a pharmaceutical company

Representing a large pharmaceutical company in courts proceedings on the appeal of decision of the Appeal Board of the Committee of Intellectual Property on cancellation of trademark registration for pharmaceuticals

Analysis of the contracts on transfer of software and databases

Registration of trademarks for a large local pharmaceutical company

SALES AND SUPPLY

Advising and legal support to large international pharmaceutical company in negotiations with the State Distributor on supply of medicines for state procurement

Advising on long-term supply contracts

Developing a unified model distribution agreement for dealing with distributors in Kazakhstan and CIS countries

Advising on various commercial matters when dealing with distributors

Advising on supply of equipment to a healthcare organisation

Advising on matters related to imports of non-registered pharmaceutical products

Advising an international pharmaceutical company on preferences provided to local pharmaceutical companies under supply agreement

Advising on feasibility of a cost sharing/risk sharing project with the government

Advising on conclusion of long-term supply contracts

SAFETY OF MEDICINES AND MEDICAL EQUIPMENT

Advising major international manufacturers of medical devices on safety regulations

Advising on clinical trials regulations

Advising on import and distribution of medicines for clinical practice in Kazakhstan

Advising an international pharmaceutical company on obtaining a permit from state authority to set up a register of patients

Advising on post-registration monitoring of medicines use

SPONSORSHIP AND TRAININGS

Advising an international pharmaceutical company on distribution of medical educational and promotional materials

Advising on regulations concerning educational grants and donations

Advising on collecting fees for patients' training classes, as well as on paying patients for participation in surveys

Advising a medical equipment manufacturer on receiving and allocation of sponsorship aid by the public healthcare authorities

Advising on legal aspects of scientific research funding

Advising a major producer of medical equipment and medicines on feasibility of a public-private partnership project for better social reintegration of patients with mental disorders

Advising on use of fees received from medical services for participation in the project of online coordination between healthcare organisations and patients

PERSONAL DATA PROTECTION

Advising on collection, processing and protection of personal data

Development and review of various consent forms for owners of personal data, including employees, their families, healthcare professionals, patients, participants of events organised by pharmaceutical companies

Advising on company's approaches to interaction with owners of personal data for compliance with the regulations of Kazakhstan and other CIS countries

Advising on applicability of the General Data Protection Regulation of the European Union in Kazakhstan

CORPORATE AND LABOUR MATTERS

Providing assistance on corporate and labour matters to a large international pharmaceutical company

Conducting legal due diligence of a subsidiary of a major international manufacturer of generic medicines

Legal support of corporate restructuring and transfer of personnel between affiliated offices of a single group of companies

Advising a large pharmaceutical company on the aspects of labor law, specifically, on payment for overtime, as well as advising upon failure to perform job responsibilities by an employee

Legal support with pre-trial settlement of labor disputes

Audit of HR related documentation for compliance with the labour regulations of Kazakhstan

Developing a policy for the conciliation commission

Advising various international pharmaceutical companies on termination of employment with the management and other employees

Registration of a subsidiary of international pharmaceutical company in Kazakhstan and advising on labour law matters

Legal assistance with development of internal labour and workplace safety policies for the local office of a medical equipment manufacturer

Advocacy support to foreign staff/secondees in interaction with the migration police of Kazakhstan

COMPETITION AND COMPLIANCE

Advising on compliance of distribution agreement with the antitrust regulation requirements and developing proposals to eliminate potential risks

Representing an international pharmaceuticals manufacturer in the claim to competing company regarding a comparison outlined in the insert sheet of a competitor's medicine

Advising an international manufacturer of an original pharmaceutical product on the strategy for protection of its rights and interests against the competitor's actions

Auditing an international pharmaceutical company to identify potential antitrust risks and risk of criminal charges against employees of the company

Advising an international pharmaceutical company on protection of its rights and interests in the context of competition law compliance

TAXATION AND CUSTOMS

Advising a pharmaceutical company on taxation of non-residents' income generated in Kazakhstan

Advising on corporate and tax matters related to the operations of representative offices and branches of international pharmaceutical manufacturers in Kazakhstan

Advising on regulatory compliance of representative offices of foreign companies which do not form a permanent establishment under the legislation of the Republic of Kazakhstan

Representing and protecting interests in the appeal over the results of customs inspection that incurred changes of the Foreign Economic Activity Commodity Nomenclature codes of imported medical products and additional customs duties charges

Advising and legal support in communication with tax authorities over the taxability of funds received by a representative office in Kazakhstan from its parent company overseas

Advising on possibility of including a local office of an international pharmaceutical company in the corporate system of internal settlement payments and funding

Advising on taxation and customs procedures in the scheme of delegated distribution arrangements involving a single authorized distributor

LITIGATION AND PRE-TRIAL SETTLEMENT

Successful representation of a subsidiary of one of the world's leading pharmaceutical companies in court proceedings over the application of a rehabilitation procedure to a debtor

Advising a European pharmaceutical company on inclusion in the register of creditors under the debtor rehabilitation procedures

Key Contacts

Aliya ZhumekenovaCounsel, Kazakhstan (Almaty)

T +7 701 788 5767E azhumekenova@gratanet.com

Aliya Zhumekenova is a Counsel with Industry and Trade and Pharmaceuticals and Healthcare Departments of GRATA International in Almaty

Aliya focuses on corporate and commercial issues, data and IP rights protection, investments and business restructuring. She has extensive experience in undertaking and supervising GRATA services for the pharmaceutical companies.

Practice areas: Contract law Corporate law

Industries: Pharmaceutical and Healthcare Industry and Trade

Shakhrukh UsmanovPartner, Kazakhstan (Almaty)

T +7 701 761 7018E shusmanov@gratanet.com

Shakhrukh Usmanov is a Partner and Head of Trade and Industry and Pharmaceuticals and Healthcare departments.

He advises and leads projects for many multinational companies in pharmaceutical, healthcare, consumer goods, information and technology industries on various matters including commercial, employment, tax, customs, intellectual property and litigation.

Shakhrukh has extensive experience in representation of pharmaceutical clients in negotiations with state authorities and third parties. He also successfully supervised representation of clients interests in a wide variety of judicial disputes in the Republic of Kazakhstan, both commercial and those in relation to actions of state authorities.

About GRATA International

Key Industry Sectors:

Banking and FinanceConstruction and InfrastructureIndustry and TradeMiningOil and GasPharmaceuticals and HealthcareTechnology, Media & TelecommunicationsTransport

GRATA International is a global network of independent law firms which are leaders in their jurisdictions and united under single brand.

250 professionals in 20 countries advise major international and local firms, funds, banks, insurance firms, construction companies, mining companies, airlines, light and heavy industry companies, telecoms, pharmaceutical companies and others.

GRATA International is present in the following jurisdictions: Azerbaijan (Baku), Belarus (Minsk), the Czech Republic (Prague), Georgia (Tbilisi), Kazakhstan (Aktau, Almaty, Atyrau, Nur-Sultan, Aktobe, Aksay, Karaganda, Kokshetau, Kostanay, Kyzylorda, Pavlodar, Petropavlovsk, Taldykorgan, Taraz, Uralsk, Ust-Kamenogorsk, Shymkent), Kyrgyz Republic (Bishkek), Moldova (Chisinau), Mongolia (Ulaanbaatar), Poland (Warsaw), Russia (Moscow, St. Petersburg, Novosibirsk , Rostov-on-Don, Samara), Switzerland (Zurich), Tajikistan (Dushanbe), Turkey (Istanbul), and Uzbekistan (Tashkent).

In addition to its offices, GRATA International has representatives in Latvia (Riga), the UK (London), the US (New York), China (Beijing), Russia (Kazan), Turkmenistan (Ashgabat), and Ukraine (Kyiv).

GRATA International is regularly acclaimed by leading international rankings: Chambers Global, Chambers Asia-Pacific, Legal 500, IFLR1000, WWL, Asialaw Profiles, and is featured in Deals of the Year Awards by China Business Law Journal. Clients have access to quality legal services in 8 industries and 15 practice areas.

Outstanding Law firmAsia Law Profiles 2018

Leading Law firmLegal500 2017, 2018, 2019

One of the leading Law firms in CISIFLR1000, 2019

‘Deals of the year' 2017, 2018China Business Law Journal

+250

20

Professionals

Countries of presence

Global presence

Azerbaijan Baku

Kazakhstan AktauAlmatyAtyrauNur-SultanAktobeAksayKaragandaKokshetauKostanayKyzylordaPavlodarPetropavlovskTaldykorganTarazUralskUst-KamenogorskShymkent

Kyrgyz RepublicBishkek

TajikistanDushanbe

RussiaMoscowRostov-on-Don

BelarusMinsk

UzbekistanTashkent

Associate officesRepresentativeoffices

Integratedoffices

GeorgiaTbilisi

MoldovaChisinau

MongoliaUlaanbaatar

PolandWarsaw

RussiaNovosibirskSamaraSt. Petersburg

TurkeyIstanbul

Czech RepublicPrague

Switzerland Zurich

UKLondon

LatviaRiga

ChinaBeijing

RussiaKazan

USANew York

TurkmenistanAshgabat

UkraineKyiv