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Head of Commercial Practice, Life Sciences
Life sciences

Life sciences

For many years, lawyers of Pepeliaev Group have been working with producers, distributors, professional associations and sector regulatory authorities. They are ready to provide comprehensive legal support with regard to regulation of the industry.

The Life Sciences practice of Pepeliaev Group was acknowledged in the ratings compiled by independent legal directory Chambers Europe. The directory quotes a client who describes our practice as follows: “The team is result-oriented and genuinely helps us in taking the necessary business decisions. It is a very strong team engaged in competition law projects and litigation relating to the pharmaceutical industry”. 

The practice offers legal services in such areas as:

The development of medicines, medical devices and biologically active additives (BAA)   

  • legal support for scientific research and pre-clinical trials; 
  • assistance in acquiring exclusive rights to IP (new inventions and medicines, medical devices and BAA circulating on the market);
  • structuring transactions in the context of scientific and technical cooperation;
  • providing support for licensing (in licensing, out-licensing)   

Clinical research and trials

  • advising on the import of medicines and the import/export of bio-material;
  • drafting the necessary contracts with medical institutions, CRO and researchers; 
  • researching BAA.


Localising manufacturing       

  • providing support for technology transfer transactions;
  • drafting contracts, taking part in negotiations; 
  • providing legal services during the construction of manufacturing complexes in the sector;
  • providing assistance during the import of equipment, reagents, specimen medicines and medical devices, and in disputes with the customs authorities;
  • advising on measures of support for domestic producers and foreign investors (preferences, special investment contracts, taking part in public procurement).     

Advising on registration issues           

  • medicines, medical devices, BAA; 
  • prices for vital and essential medicines, and for implantable medical devices;      
      

Wholesale and retail              

  • legal support in the construction of distribution chains in Russia; 
  • drawing up contracts and commercial policies, distributor selection policies and negotiation strategies; 
  • providing support in the context of cooperation with wholesaler and retailer companies;
  • representing clients in disputes with buyers and suppliers; 
  • providing support in foreign trade transactions. 

Advertising and working with the professional community

  • legal assistance in the area of promoting prescription and non-prescription medicines, medical devices and biologically active additives; 
  • legal support in relation to dealing with medical and pharmaceutical professionals; 
  • drawing up contracts: 
  1. with producers and distributors of advertising;
  2. with healthcare workers. 
           

State control and supervision, interacting with consumers   

  • legal support in the context of control over the circulation of medicines, medical devices and BAA; 
  • involvement in inspections carried out by supervisory authorities of companies in the pharmaceutical, para-pharmaceutical and medical sectors;
  • safeguarding a client's interests when it appeals the actions of regulatory bodies in areas such as healthcare, antitrust, consumer rights, drugs, customs and others; 
  • handling issues arising in the licensing of pharmaceutical and medical activities, production and maintenance;
  • disputes with consumers;
  • a comprehensive regulatory audit of companies in the sector.


Public procurement 

  • advising on issues arising in public procurement exercises for medicines and medical devices; 
  • advising on the budgetary process, and planning for and financing public procurement exercises; 
  • appealing against procedures applied in bidding processes. 

         
Mergers and acquisitions of assets on the market               

  • due diligence of target companies and assets (medicines, pharmaceutical substances and so on); 
  • structuring transactions having regard to the particular features of the regulatory regime and business in the pharmaceutical and medical sector. 
             

The healthcare sector                        

  • full legal support for the construction and fitting out of private medical institutions; 
  • legal support for public-private partnership projects in healthcare; 
  • advising on issues arising in state procurement by publicly funded institutions; 
  • providing legal assistance in resolving issues concerning compulsory medical insurance (CMI), including private organisations within the CMI system; 
  • advising on issues concerning specific types of medical support. 

Projects

Legal support during a major transaction on the Russian pharmaceutical market Pepeliaev Group's lawyers advised a major pharmaceutical company on various aspects of Russian legislation related to the establishment of an international joint venture with another international pharmaceutical company by merging their Russian subsidiaries.
In the context of the deal, our lawyers provided detailed advice on matters of structuring the Russian part of the transaction as well as related tax, customs, and labour issues. Among our team’s tasks was obtaining clearance of the transaction from the Russian antitrust regulator. The transaction was unique because, to achieve an internal business restructuring, the client effected three simultaneous transfers of participatory interests in a Russian limited liability company and two simultaneous share transactions in a Russian joint-stock company. This is the first and so far the only transaction on the Russian market in which major international pharmaceutical companies have been involved.
Developing a legal position for a german pharmaceutical company allowing it to avoid claims from customs authorities

At the client’s request, our firm’s lawyers prepared documents proving that the cost of imported goods was not affected by the fact that the parties under the transaction were related. Owing to this, during a customs inspection the client managed to prove substantially reduced purchase prices were related to its transitioning from taking supplies from independent Russian purchasers to its own distributor supplying the goods.

Other projects