Pepeliaev Group strengthens in Pharmaceuticals and Healthcare

In April 2012, Pepeliaev Group’s Pharmaceuticals and Healthcare Group was strengthened by the recruitment of Irina Naumenko as a Senior Associate. Irina joins from a major pharmaceutical company.

Irina Naumenko has more than thirteen years’ experience of working in major international companies active on the FMCG and pharmaceutical markets. During her career, Irina has gained experience of drafting contracts of various levels of complexity (including those governed by foreign laws), as well as drafting internal company regulations relating to various aspects of companies’ business, resolving customs and antimonopoly issues, and creating and managing intellectual property. In addition, she has liaised on behalf of companies with regulatory authorities, has been involved in M&A projects, and has regularly represented companies in court.

At Pepeliaev Group, Irina advises clients about the legal aspects of: manufacturing medicines (both the full cycle and specific stages); conducting clinical research; promoting and advertising medicines, biologically active supplements, medical products and medical equipment; the wholesale and retail sale of medicines; setting prices; and antimonopoly legislation, among other things.

Irina graduated with distinction from the Belarus State University as a lawyer and then completed a training course at the Russian Government’s Academy of National Economy. She obtained her master of laws degree (LL.M.) with distinction from Manchester University in the UK, and passed the Marketing and Business Excellence course of the Indian Institute of Management in Calcutta, finishing as one of the ten best students on the programme.

It is of Pepeliaev Group’s key priorities to develop its Pharmaceuticals and Healthcare Group. The Group’s clients are major manufacturers and distributors of medicines and medical products.

Elena Lvova, Senior Associate, is the coordinator of the Pharmaceuticals and Healthcare Group.

Elena Lvova works with pharmaceutical companies, and with manufacturers and distributors of medical products. Elena advises clients on: carrying out clinical research; taking part in clinical research; registering and approving the registration of medicines; setting prices; and the manufacture and wholesale and retail sale of medicines, medical equipment and medical products.

Elena previously worked as an in-house lawyer in a major international pharmaceutical company, which has given her a rich experience in drafting and checking contracts and internal regulations associated with manufacturing and distributing medicines, medical equipment and medical products.

In addition, Elena specialises in antimonopoly regulation in the pharmaceuticals and healthcare sector, advising pharmaceutical companies, and manufacturers and suppliers of medical products. She provides support during inspections of such companies by the antimonopoly authorities. Elena also works on issues relating to the promotion of medicines (including advertising), medical technology and medical products.

Elena graduated with distinction from the O.E. Kutafin Moscow State Academy of Law. Before joining Pepeliaev Group, she worked as a consultant in the Moscow office of Deloitte and Touche.

The Pharmaceuticals and Healthcare Group is headed by Vladimir Sokov, a Partner in Pepeliaev Group.

“Strengthening the Pharmaceuticals and Healthcare Group means that we can swiftly and effectively perform the tasks we are set by our clients,” states Vladimir Sokov. He considers that highly qualified legal advisers who have been working for many years with manufacturers, distributors and regulatory authorities, help clients to find effective solutions to the legal problems that come up during their work, to mitigate potential risks, and to document and optimise their business processes. Our lawyers’ track record in the sector creates additional possibilities for developing a dynamic and complex market.

Services of the Pharmaceuticals and Healthcare Group:

• Advice on legal issues relating to:
  • conducting clinical and post-marketing research of medicines, and expert surveys of medical products;
  • registration of medicines and confirmation of such registration, and registration of medical products;
  • production, manufacturing, storage, transportation, import into Russia and export from Russia, retail and storage of medicines and medical products;
  • registration of the prices for vital and essential medicines;
  • provision of medical services;
  • licensing of the manufacture of medicines, pharmaceuticals and medical activity and of activity involving the manufacture of medical equipment; and
  • working together with healthcare experts.
    
    
• Legal support on commercial issues, taking part in negotiations with contracting parties, drafting agreements (distribution, supply, marketing services and others), advice on supply chains, the leasing of equipment, setting up cooperation arrangements etc.
  
  
• Advice on protecting rights to intellectual property (patents and trademarks).
  
  
• Legal analysis of and advice on:
  • advertising,
  • antimonopoly regulation in the pharmaceutical sector,
  • participation in state procurement and public sector projects, risk management,
  • taxation (including clinical research, discounts, bonuses, and the import of samples of medicines), applying  tax benefits in the pharmaceutical industry;
  • regulation of cross-border trade with regard to the sales of medicines and medical products.
    
    
• Support in M&A transactions, including:
  • advice on structuring transactions;
  • drafting and preparing all transaction documents;
  • negotiating on behalf of clients with other parties to transactions;
  • advising on tax matters in the context of M&A transactions and on other issues.
    
    
• Seconding our employees to work as in-house lawyers of our clients (outstaffing).
  
  
• Representing and defending clients:
  • before courts (commercial, tax and customs disputes, disputes involving the protection of intellectual property, challenging decisions of healthcare authorities);
  • before state authorities (healthcare, customs, tax and antimonopoly authorities).
    
    
• Drafting legislation, and lobbying for pharmaceutical companies when we are involved in legislative drafting.
  
  
• Holding training sessions and seminars on regulatory, antimonopoly, tax and other issues.