The Legal 500 > Europe, Middle East & Africa > Bulgaria > Healthcare and life sciences

Boyanov & Co. handles a wide range of corporate and commercial matters for clients in the pharmaceutical industry. Kina Chuturkova, who advises on mergers, acquisitions, restructurings, contracts and ongoing regulatory compliance, and Peter Petrov, who is a specialist in pharmaceutical regulation, jointly head the practice. The latter acted for the Association of Research-based Pharmaceutical Manufacturers in Bulgaria (ARPharM) on amending proposed changes to the new regulations on biosimilar pharmaceutical products. The firm advises several major pharmaceutical companies on an ongoing basis, including AbbVie, Merck, GlaxoSmithKline and Medtronic. Nedyalka Novakova is another name to note.

The healthcare and life sciences practice at CMS is well placed to advise large pharmaceutical companies active across the European Union. The Sofia team handles regulatory compliance, reimbursement procedures, employment issues, and import authorisations for market-leading pharmaceutical companies, including Johnson & Johnson. Notably, in conjunction with its other offices, the Sofia team assisted with the Bulgarian compliance of Advent International’s €1.9bn acquisition of Zentifa. Senior associate Angelika Sedlackova leads the team, and has experience of advising on medicine and medical device reimbursement procedures through Bulgaria’s National Health Insurance Fund.

Dimitrov, Petrov & Co handles complex regulatory and compliance matters for clients in the pharmaceutical and medical industries. The ‘dedicated’ team advises on Bulgarian price regulations and reimbursement procedures through the National Health Insurance Fund, clinical trial compliance, intellectual property and patent issues, competition and antitrust matters, and data protection and privacy. As well as advising major established players including Pfizer, Johnson & Johnson, and Eli Lilly, the firm has acted for market newcomers and clients at the cutting edge of medical technology and services, including a DNA diagnostic lab, e-health platforms, and manufacturers of new medical technologies. Practice head Bilyana Angelova  is well versed in contentious matters. Partner Zoya Todorova is an expert in pharmaceutical regulation. Senior associate Encho Simeonov and associate Alexandra Lassina are also noted.

Djingov, Gouginski, Kyutchukov & Velichkov advises major pharmaceutical companies, including Aspen, Merck & Co., and Astellas Pharma Europe, on their activity in Bulgaria. Practice head Kalina Tchakarova has expertise in reimbursement procedures through the National Health Insurance Fund, distribution agreements, advertising restrictions and IP and patent issues. Anton Petrov focuses on the regulation of clinical trials and the development of medical devices. The firm also acts in contentious matters, having represented pharmaceutical companies before the Commission for the Protection of Competition and defended patents and intellectual property.

Tsvetkova Bebov Komarevski’s healthcare and life sciences practice chiefly assists clients in the pharmaceutical sector with compliance in a strict regulatory environment. The firm works on an ongoing basis for AstraZeneca, Takeda and Polpharma regarding their operations in the country, including providing guidance on employment matters, marketing campaigns, reimbursement and the introduction of new medicines, as well as M&A deals and contentious matters. The team also has expertise in assisting with supplements and food standards regulation, having worked for Lidl and Mars on product labelling standards, recall of products, and food production safety standards. Ilya Komarevski leads the team. Eleonora Mateina and Philip Kiossev are other key contacts.

Wolf Theiss handles corporate and commercial matters for clients in the healthcare and pharmaceutical industries. Additionally, the team has advised banks and investment firms on M&A transactions in the pharmaceutical industry, advising on the data protection, intellectual property transfer, and antitrust implications of acquisitions in the sector. The team also assists foreign pharmaceutical companies with the regulatory requirements regarding market entry, and has advised on compliance for clinical trials. The practice is headed by Anna Rizova. Senior associate Hristina Dzhevlekova is another name to note; she leads on many of the firm’s major cases, and has acted for AstraZeneca and Eli Lilly.

Deloitte Legal Law Firm advises on the Bulgarian regulatory framework covering pharmaceuticals and healthcare for major international firms, and general regulatory compliance and contracts for companies in the sector. The team handles anti-money laundering and GDPR compliance, labor law issues, tax matters, medicine pricing restrictions, and contractual relationships with medical professionals for healthcare providers. The group also assists international companies with entering into the Bulgarian market. Reneta Petkova and Miglena Micheva lead the team and Irena Koleva is also noted.

Georgiev, Todorov & Co focuses on handling disputes in the healthcare sector, with a successful track record in representing hospitals and medical centres in reimbursement disputes with the National Health Insurance Fund. Notably, the team acted for MBAL Hospital Evropa, successfully appealing against the revocation of its licence by the regulatory authorities before the Supreme Administrative Court. Non-contentious work includes the provision of ongoing advice regarding regulatory compliance, data protection, licensing and employment issues.  Ivan Todorov heads the team, which includes senior associate Mariya Derelieva, who is particularly active. Tsvetelina Dimitrova and Alexander Pachamanov are other key contacts.

The ‘capable and dependable’ team at Murgova & Partners Attorneys at Law advises medical associations, specialised hospitals, and patient support programme operators on compliance, patient data protection, employment issues, and  internal rules and procedures to minimise the risk of malpractice. The team is jointly led by Alexander Stoimenov and Petya Murgova. The ‘highly effective’ Simeon Krastev is another key contact.

Penkov, Markov & Partners advises on the requirements and conditions for conducting clinical trials for medicines and medical devices for manufacturers and the hospitals where the trials are to be conducted. The team also advises on commercial and regulatory matters for clients in the sector, covering data protection, competition and marketing issues, National Health Insurance Fund reimbursement, licensing, and distribution agreements. Vladimir Penkov and Roman Stoyanov, who advises on contentious matters, jointly lead the team.

Schoenherr (in cooperation with Stoyanov & Tsekova) advises on the wholesaling of medicines and medical devices, pharmaceutical marketing regulations, and restrictions on medicine pricing and reimbursement. The firm also has experience of food safety, having advised Amway, a nutritional supplement multi-level marketing company, and OMV Bulgaria on food safety in its petrol station supermarkets. Corporate and commercial work is a core part of the firm’s healthcare and life sciences practice – it has advised on mergers in the sector, general regulatory compliance, and data protection laws. The ‘efficient’ and ‘proactive’ Elena Todorova leads the practice.

Stoeva, Tchompalov & Znepolski has a focus on commercial, contractual, and compliance issues for pharmaceutical companies. Key clients include GlaxoSmithKline and Perrigo, an over-the-counter medicine producer. The firm has also advised Sofia Business Consulting Group on the distribution and marketing of new medical devices developed by Human Brain Wave, a biotechnology company. Irina Stoeva leads the team and of counsel Vania Todorova handles the majority of the team's work for GlaxoSmithKline.