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PHARMACEUTICALS AND HEALTH CARE

PHARMACEUTICALS AND
HEALTH CARE

Pharmaceuticals is one of the most stringent regulatory areas due to its special social importance. At the same time, there we see probably the strongest competitive potential.
The commercial aspects of the industry companies activity, as well as the internal business organization issues, stay in focus of the practice. We have gained extensive experience in advising on various aspects of pharmaceutical and health regulations. Now this allows us not only to highlight the area of the strongest competence of our practice, but also to offer our own unique solutions.
PRAVO.RU-300 2020
  • Group II: Pharmaceuticals and Healthcare (2020, 2019, 2018)
KOMMERSANT 2020
  • Healthcare: resolution of key disputes in this sector (No. 8 on market)
  • Healthcare: leaders consulting in sectors of medical services and pharmacology (No. 8 on market)
BEST LAWYERS 2021
  • Life sciences practice
    The personal ranking of Sergey Patrakeev, Partner
KOMMERSANT 2020 (personal ranking)
  • Healthcare
    The personal ranking of Sergey Kislov, Partner

COMMERCIAL COMPETENCIES

  • CONTRACTS AND BUSINESS TRANSACTIONS
INDIVIDUAL AND STANDARD CONTRACTS ON ALL ASPECTS OF ACTIVITY (DISTRIBUTION, CLINICAL RESEARCH, TRANSFER OF EXCLUSIVE RIGHTS, TECHNOLOGY TRANSFER, MARKETING ACTIVITIES, CHARITABLE ACTIVITIES, ETC.), COMPLIANCE WITH CONTRACTUAL PROCEDURES, NEGOTIATIONS ON THE TERMS OF CONTRACTS, RESTRUCTURING OF CONTRACTUAL OBLIGATIONS

  • CORPORATE ASPECTS
ESTABLISHMENT AND REORGANIZATION OF BUSINESS ENTITIES, REPRESENTATIVE OFFICES, ORGANIZATION OF CORPORATE GOVERNANCE, IMPLEMENTATION OF CORPORATE PROCEDURES

  • COMPLIANCE AND IMPLEMENTATION OF GOOD PRACTICES
LEGAL DUE DILIGENCE OF THE CLIENT'S ACTIVITIES IN GENERAL AND ON SEPARATE OPERATIONAL PROCEDURES, DEVELOPMENT AND ADJUSTMENT OF INTERNAL POLICIES, DEVELOPMENT OF RECOMMENDATIONS FOR THE IMPLEMENTATION OF REGULATORY REQUIREMENTS TO GOOD PRACTICES, INDUSTRY CODES OF ETHICS, AND RECOMMENDATIONS OF REGULATORS
SELECTED EXPERIENCE
  • CORPORATE AUDIT FOR THE RUSSIAN DIVISION OF INDIAN PHARMACEUTICAL WITH A PROPOSAL OF PRACTICAL STEPS TO OPTIMIZE CORPORATE GOVERNANCE
  • AUDIT WITH REGARD TO THE REQUIREMENTS RELATED TO PERSONAL DATA CIRCULATION IN THE RUSSIAN DIVISION OF THE AMERICAN PHARMACEUTICAL COMPANY
  • ADVISING A JAPANESE MANUFACTURER OF OPHTHALMIC DRUGS ON BUSINESS RESTRUCTURING IN RUSSIA (TRANSFER OF OPERATIONS FROM A REPRESENTATIVE OFFICE TO A SUBSIDIARY LLC)
  • ADVISING A BALTIC MANUFACTURER OF THE DRUG RESTORING THE MUSCLE ACTIVITY IN CONNECTION WITH THE DEVELOPMENT OF MODEL AGREEMENTS FOR THE PROMOTION OF A PRESCRIPTION DRUG WITH A NARROW THERAPEUTIC INDEX IN RUSSIA, AND FOR THE APPROPRIATE SUPPORT OF RELATED MARKETING ACTIVITIES
  • ADVISING A SWISS PHARMACEUTICAL COMPANY ON GOOD PRACTICES IN DEALING WITH HEALTHCARE PROFESSIONALS

    REGULATORY COMPETENCIES

    PARTICIPATION IN PUBLIC PROCUREMENT, IMPLEMENTATION OF INVESTMENT OBLIGATIONS, LICENSING CONTROL, CONFIRMATION OF GOOD PRACTICES, ADVERTISING, CUSTOMS CLASSIFICATION
    SELECTED EXPERIENCE
    • ADVISING A RUSSIAN MANUFACTURER OF METABOLITE DRUGS ON THE RENEWAL OF A LICENSE FOR THE PRODUCTION OF MEDICINAL PRODUCTS
    • ADVISING A EUROPEAN PHARMACEUTICAL MANUFACTURER IN CONNECTION WITH THE APPLICATION OF THE REQUIREMENTS OF THE RUSSIAN LEGISLATION ON THE INDICATION OF THE PURCHASED ITEM IN RELATION TO A MEDICINAL PRODUCT OF BIOLOGICAL ORIGIN NOT CLASSIFIED BY INN
    • REPRESENTING INTERESTS OF A RUSSIAN DISTRIBUTOR OF A EUROPEAN BRAND OF COSMETIC PRODUCTS IN THE ADMINISTRATIVE PROCEEDINGS ON THE PROPER COMPOSITION OF ONE OF THE DISTRIBUTED COSMETIC PRODUCTS
    • ADVISING AN INTERNATIONAL DIAGNOSTIC COMPANY ON THE REGISTRATION OF MEDICAL DEVICES IN RUSSIA, AS WELL AS IN CONNECTION WITH THE APPLICABLE REQUIREMENTS TO THE IMPORT OF BIOMATERIAL (BLOOD SAMPLES) FROM RUSSIA
    • ADVISING TO SEVERAL PHARMACEUTICAL MANUFACTURERS ON THE CONTENT OF COMMERCIALS PLANNED FOR PLACEMENT IN THE RUSSIAN MEDIA, IN TERMS OF COMPLIANCE WITH THE LAWS ON ADVERTISING AND THE FAS ENFORCEMENT APPROACHES

      TRANSACTION SUPPORT

      SUPPORT OF CORPORATE TRANSACTIONS, INVESTMENT PROJECTS, JOINT VENTURE PROJECTS (INCLUDING CONTRACT MANUFACTURING, OTHER FORMS OF LOCALIZATION), TRANSACTIONS ON ACQUISITION OF REAL ASSETS
      SELECTED EXPERIENCE
      • SUPPORT OF THE ACQUISITION OF A PORTFOLIO OF NATURAL SEDATIVES AND DIETARY SUPPLEMENTS ON THE SIDE OF THE RUSSIAN COMPANY – THE ACQUIRER
      • SUPPORT OF AN INDIAN PHARMACEUTICAL COMPANY IN THE PROCESS OF ESTABLISHING A JOINT VENTURE WITH A RUSSIAN PARTNER IN ORDER TO ORGANIZE FULL-CYCLE PRODUCTION AND TO ACQUIRE A SOLE SUPPLIER STATUS AS A RESULT THEREOF
      • REPRESENTING A JAPANESE MEDICAL EQUIPMENT MANUFACTURER IN THE RUSSIAN PART OF A TRANSACTION TO ACQUIRE A HEMODIALYSIS BUSINESS FROM A GLOBAL AMERICAN COMPANY

        DISPUTE RESOLUTION

        PROCESSING OF CLAIMS FROM PARTICIPANTS IN THE DISTRIBUTION CHAIN, END USERS, REGULATORY AND SUPERVISORY AUTHORITIES; REPRESENTATION OF CLIENT'S INTERESTS IN THE ADMINISTRATIVE PROCEEDINGS; DEFENDING CLIENTS ' INTERESTS IN THE RUSSIAN STATE COURTS, INTERNATIONAL ARBITRATION TRIBUNALS, THIRD-PARTY ARBITRATION COURTS, AND IN MEDIATION PROCEDURES
        SELECTED EXPERIENCE
        • REPRESENTING A FRENCH PHARMACEUTICAL MANUFACTURER IN THE BANKRUPTCY PROCEEDINGS OF A RUSSIAN DISTRIBUTOR
        • SUPPORT OF THE BANKRUPTCY PROCEEDINGS OF THE RUSSIAN BRANCH OF THE FINNISH PHARMACEUTICAL DISTRIBUTOR IN THE CONTEXT OF ALIENATION OF JOINT OWNERSHIP TO A NATIONAL PHARMACY CHAIN (WITH THE SUBSEQUENT BRINGING OF THE PHARMACY CHAIN BENEFICIARIES TO SUBSIDIARY LIABILITY)
        • RECOVERY OF LOSS FROM THE NATIONAL PHARMACY CHAIN AS A JOINT AND SEVERAL DEFENDANT ON THE DEBTS OF A LARGE PHARMACEUTICAL DISTRIBUTOR
        • REPRESENTATION OF A NATIONAL DISTRIBUTOR WITH AN EXCLUSIVE LICENSE FROM THE MANUFACTURER, IN A DISPUTE ON THE INFRINGEMENT OF RIGHTS TO USE THE TRADEMARK IN RESPECT OF A DISTRIBUTABLE PRODUCT
        • ADVISING A SWEDISH PHARMACEUTICAL MANUFACTURER IN A DISPUTE WITH THE FCS ON THE ASSIGNMENT OF A CORRECT PRE-CLASSIFICATION CODE
        • REPRESENTING A JAPANESE MANUFACTURER OF OPHTHALMIC DRUGS IN A DISPUTE ON THE DISMISSAL OF AN EMPLOYEE

          DATA MANAGEMENT AND INFORMATION PROTECTION (DATA-COMPLIANCE)

          IN THEIR ACTIVITIES, PHARMACEUTICAL COMPANIES AND MEDICAL ORGANIZATIONS OFTEN FACE THE NEED TO PROCESS INFORMATION AND DATA THAT FALL UNDER A PARTICULAR SPECIAL LEGAL REGIME – PERSONAL DATA, EXCLUSIVE DATA ON CLINICAL TRIALS, MEDICAL SECRECY, TRADE SECRETS, KNOW-HOW, ETC.
          IT IS ALSO NECESSARY TO ADD TO THIS DATA ARRAY THE INFORMATION ON TRACKING THE PATH OF A DRUG ALONG THE DISTRIBUTION CHAIN – IN ORDER TO FULFILL MANDATORY REQUIREMENTS TO LABELING.
          FOR HEALTH CARE ORGANIZATIONS, USING DATA FROM UNIFIED INFORMATION SYSTEMS CREATED IN FURTHERANCE OF TELEMEDICINE LEGISLATION BECOMES A MATTER OF PARTICULAR RELEVANCE.
          HOWEVER, CONSTANT ATTENTION IS ALSO REQUIRED TO TRANSFER INFORMATION IN THE FORMAT OF EXTERNAL COMMUNICATIONS (ADVERTISING, MARKETING ACTIVITIES), WHICH REQUIRES COMPLIANCE WITH A NUMBER OF ADDITIONAL REGULATORY REQUIREMENTS AND RESTRICTIONS.
          IT IS VERY IMPORTANT TO SYSTEMATIZE ALL THIS VARIETY OF INFORMATION AND DATA AND MAKE IT A MANAGED ASSET.

          WE HELP:

          • AUDIT THE COMPANY'S INFORMATION AND DATA HANDLING PROCEDURES, IDENTIFY RISK POINTS, AND SUGGEST WAYS TO OPTIMIZE / ELIMINATE SUCH RISKS
          • BUILD A UNIFIED SYSTEM OF CLASSIFICATION OF INFORMATION AND DATA CIRCULATING WITHIN THE COMPANY, FOLLOWED BY AUTOMATIC APPLICATION, IF NECESSARY, OF A SPECIAL LEGAL REGIME (OR SEVERAL REGIMES)
          • FORM THE RULES OF EXTERNAL COMMUNICATIONS, AS WELL AS THE PROCEDURE FOR PROVIDING PROTECTED INFORMATION AND DATA TO THIRD PARTIES
          • TAKE THE NECESSARY STEPS TO SUCCESSFULLY PASS THE CONTROL AND OVERSIGHT ACTIVITIES INVOLVING THE EXCHANGE OF INFORMATION AND DATA FALLING UNDER SPECIAL LEGAL REGIMES

          ANTI-COUNTERFEITING

          THE CIRCULATION OF COUNTERFEIT PRODUCTS IS ONE OF THE MOST PRESSING ISSUES IN THE FIELD OF INTELLECTUAL PROPERTY PROTECTION FACED BY PHARMACEUTICAL COMPANIES.
          BOTH PRODUCTS IMPORTED TO THE COUNTRY AS A PARALLEL IMPORT, AND FAKE PRODUCTS PRODUCED, AMONG OTHER THINGS, WITHIN THE COUNTRY MAY BE CONSIDERED COUNTERFEITING.
          EFFECTIVE ANTI-COUNTERFEITING IS POSSIBLE ONLY AS A RESULT OF SYSTEMATIC WORK THAT BRINGS TOGETHER A NUMBER OF FUNCTIONAL UNITS WITHIN THE COMPANY, EXTERNAL CONSULTANTS, AS WELL AS REGULATORY AND LAW ENFORCEMENT AGENCIES.

          WE HELP:

          • DEVELOP A STRATEGY AGAINST COUNTERFEITING, AS WELL AS AN ACTION PLAN THAT WOULD TAKE INTO ACCOUNT THE SPECIFICS OF A PARTICULAR COMPANY, AND THE PECULIARITIES OF CIRCULATION OF A COUNTERFEIT PRODUCT
          • BUILD A METHODICALLY COMPETENT SYSTEM OF FIXING IDENTIFICATION, ANALYSIS, AND RESPONSE ACTIONS
          • IMPLEMENT A SET OF ACTIONS TO BRING OFFENDERS TO LEGAL RESPONSIBILITY
          KEY CONTACTS
          KSENIA STEPANISHCHEVA
          COUNSEL
          15 years of multidisciplinary consulting practice
          E-mail: bestlawyers@ktaplaw.ru
          CV