Healthcare and life sciences in Bulgaria

Boyanov & Co.

Boyanov & Co. is well regarded in the healthcare and life sciences space for its stellar client roster of pharmaceutical manufacturers, generics companies and pharmacies. The firm has extensive experience relating to Bulgarian and EU regulations in the pharma sector and is therefore well placed to advise on a broad range of market access issues, intellectual property protection and trade mark registration, patent litigation and commercial disputes regarding the sale of medicines and pharmaceutical price regulation matters. Dispute resolution expert Kina Chuturkova represents pharmaceutical clients in litigation and international arbitration proceedings, while Peter Petrov uses his regulatory and EU law expertise when advising landmark clients such as Pfizer, Merck and AbbVie on an ongoing basis. Nedyalka Novakova further strengthens the team's offering.

Responsables de la pratique:

Kina Chuturkova; Peter Petrov


Autres avocats clés:

Nedyalka Novakova


Principaux clients

Neola Pharma EOOD


F. Hoffmann La Roche


AbbVie


ARPharM Bulgaria


Bayer


Novartis


GSK


Celgene Corporation


Merck


Medtronic


Pfizer Bulgaria


Anika Therapeutics


AstraZeneca


Baxter Health


Stada


ICON Plc


Ferring Pharmaceuticals


Grünenthal


Allergan, Inc.


Roche Bulgaria


Sandoz


Pharmapro


Syneos Health


Sofmedica


Arcadia Consumer Healthcare


Ottobock


MagnaPharm


Principaux dossiers


  • Representing a global innovative pharmaceutical manufacturer in its challenge against Bulgarian legislation.
  • Supported the Bulgarian pharmaceutical industry association ARPharM in its advocacy efforts to ensure a sustainable supply of therapies to Bulgarian patients in the context of various legislative initiatives.
  • Continuing to regularly advise a significant portfolio of global pharmaceutical leaders, including AbbVie, AstraZeneca, Bayer, GSK, Merck, Novartis, Pfizer, Sandoz, Roche and others, on various aspects of their presence in the Bulgarian pharmaceutical market.

Dimitrov, Petrov & Co

Dimitrov, Petrov & Co is highly regarded for its ‘in-depth knowledge of the life sciences sector’ where the team covers a litany of matters that relate to intellectual property, commercial, competition, data protection, corporate and employment law. The team is well placed to provide day-to-day advice to clients such as Pfizer, Johnson & Johnson and Eli Lilly thanks to its expertise in the Bulgarian regulatory framework and market conditions. Furthermore, the team is well regarded for its strength in patent litigation and experience in medical malpractice cases (a specialism of recently promoted partner Encho Simeonov). The practice is led by Zoya Todorova and Martin Zahariev, the latter of whom was promoted to partner in March 2023. Todorova advises pharma and life sciences companies on corporate matters and M&A transactions, while Zahariev leverages his expertise in IP field, among others, to support global life sciences companies. Yana Georgieva is also a key member of the team.

Responsables de la pratique:

Zoya Todorova; Martin Zahariev


Autres avocats clés:

Yana Georgieva; Encho Simeonov; Radina Tomanova


Les références

‘I have worked with DPC for several years now due to their strong expertise in the life sciences. They are prompt, very efficient and thorough, and are very receptive to clients’ needs and priorities. I highly recommend the life sciences team!’

‘I worked with Yana Georgieva and Zoya Todorova on various matters. They were very prompt and thorough, and their technical and analytical skills were helpful in navigating our business.’

‘The team secured a highly favourable outcome in my case, exceeding my expectations. Their presence in negotiations was impressive, and their ability to navigate complex legal issues with finesse was truly commendable. I am immensely grateful for their dedicated efforts, which resulted in a successful resolution.’

Principaux clients

Pfizer Luxemburg SARL, Bulgaria Branch


Johnson & Johnson Bulgaria EOOD: Janssen-Cilag International


Eli Lilly/SUISSE/SA


Medison Pharma Trading


Zaklady Farmaceutyczne POLPHARMA S.A.


Ekarisaj-Varna EOOD


Ergomed


PMA – Pharma Marketing Advisors


Hell Energy


Nova Kletka – BG EOOD


Principaux dossiers


  • Providing daily legal support to Pfizer Luxemburg SARL, Bulgaria Branch.
  • Providing regular legal advice on a variety of matters to Janssen-Cilag.
  • Providing regular legal advice on a variety of matters to Eli Lilly (Suisse) SA.

Djingov, Gouginski, Kyutchukov & Velichkov

Domestic and international life sciences companies, pharmaceutical manufacturers and retail companies, as well as medical institutions, turn to Djingov, Gouginski, Kyutchukov & Velichkov‘s pharma and healthcare practice group thanks to its broad advisory offering in this sector. Due to the firm’s full-service setup, the team is able to assist clients with matters ranging from day-to-day assistance, project-based legal assistance, commercial agreements, and representation in administrative and litigation proceedings, through to compliance advice on clinical trial agreements. Kalina Tchakarova heads up the practice and is well regarded for her expertise in the field of IP law, and experience advising pharmaceutical companies on medicinal products regulation.

Responsables de la pratique:

Kalina Tchakarova


Autres avocats clés:

Dessislava Iordanova


Principaux clients

Biogen Netherlands BV


International SOS


Swedish Orphan Biovitrum AB


Novavax, Inc.


Viatris (Mylan Ireland Limited and Mylan EOOD)


Teva Pharmaceuticals Europe BV


General Electric Healthcare


Alnylam Pharmaceuticals, Inc


Novo Nordisk A/S


Organon Pharma (UK) Limited


Principaux dossiers


  • Advised Biogen Netherlands BV in a case regarding a leading medicinal product that had an expiring patent protection but was still protected against placement on the market of generic analogues.
  • Assisted Swedish Orphan Biovitrum AB with various matters related to its market presence in Bulgaria.
  • Advises Viatris in pending litigation related to the alleged infringement of the rights of Bayer HealthCare LLC to an EU patent in Bulgaria.

CMS

A standout feature of CMS‘ healthcare practice is its experience across Central and Eastern Europe, predominantly in multi-jurisdictional M&A transactions and divestments for pharmaceutical, biotechnology and medical devices clients. In addition, the team's varied caseload includes advice on clinical trials and non-interventional studies, as well as daily legal assistance on regulatory and commercial matters, data protection, marketing and employment queries. Litigation expert Assen Georgiev leads the practice alongside Anna Tanova, who covers various commercial matters pertaining to the life sciences and healthcare industry.

Responsables de la pratique:

Assen Georgiev; Anna Tanova


Principaux clients

Johnson & Johnson


Essity


Principaux dossiers


  • Advising Johnson & Johnson on a wide range of commercial, personal data protection, regulatory, contract review, IP and employment matters, as well as on the establishment and conduct of clinical trials and non-interventional studies in Bulgaria.
  • Advising Essity on issues regarding possible retail brand compatibility and composability claims in Bulgaria.

Deloitte Legal Law Firm

Deloitte Legal Law Firm is well placed to assist national and multinational healthcare and pharmaceutical clients with matters pertaining to tax, accounting, finance and regulatory compliance, due to its ‘diverse and broad legal knowledge’. Practice head Miglena Micheva is well versed in medical law, data privacy and pharma regulations. Further key contacts for this practice are Irena Koleva and Zvezdelina Filova.

Responsables de la pratique:

Miglena Micheva


Autres avocats clés:

Irena Koleva; Zvezdelina Filova


Les références

‘The team has very diverse and broad legal knowledge. They are highly professional.’

‘We worked with Irena Koleva. Every task was done and delivered on time and with excellent output. Irena is truly a superb lawyer in her field of privacy and IP.’

‘Very quick responses and high-quality legal work.’

Eversheds Sutherland

Eversheds Sutherland, which merged with local firm Tsvetkova Bebov and Partners in June 2022, assists pharmaceutical and food companies with regard to competition and contract law issues, as well as representing clients in commercial and administrative litigation proceedings. Among the matters the team is regularly instructed on are market access issues, pricing and reimbursement legislation, clinical trial agreements and compliance with regulations. The team is jointly led by Irina Tsvetkova and Eleonora Mateina, the latter of whom is praised for her ‘stunning knowledge of pharmaceutical law.

Responsables de la pratique:

Irina Tsvetkova; Eleonora Mateina


Les références

‘They have more than 20 years’ experience working with big pharma companies – they know the industry, the legislation, the background and the market players.’

‘Eleonora Mateina is always available, very quick and very efficient, with stunning knowledge of pharmaceutical law and business.’

Principaux clients

Applied Molecular Transport, Inc.


AstraZeneca


Mars and Royal Canin


Podravka


Principaux dossiers


  • Providing legal support to AstraZeneca in Bulgaria on an ongoing basis regarding regulatory, pricing and reimbursement, ethical, commercial, employment, personal data protection and other matters.
  • Advised Applied Molecular Transport, Inc., in its capacity as sponsor, and Alimentiv B.V., in its capacity as CRO, on the conduct of clinical trials in Bulgaria in several clinical sites across the country.
  • Advising Mars, Inc. on a recurring basis on matters including pet food regulation in Bulgaria and representation before the administrative authorities and courts in cases related to labelling, placing products on the market, product recalls and mandatory registrations.

Georgiev, Todorov & Co

Georgiev, Todorov & Co advises hospitals, medical institutions, and pharmaceutical and cosmetic companies on an ongoing basis regarding intellectual property matters, mergers and acquisitions, medical supply agreements and compliance with the regulatory framework. The team led by Ivan Todorov is well versed in healthcare and life sciences-related disputes and administrative proceedings.

Responsables de la pratique:

Ivan Todorov


Autres avocats clés:

Tsvetelina Dimitrova


Les références

‘Georgiev, Todorov & Co has a team of exceptional professionals, with a wide range of expertise in the fields of practice in which we collaborate with them. Up to this moment they have always managed to find a quick and accurate approach to the solution of legal disputes.’

‘The legal team from Georgiev, Todorov & Co stands out for its exceptional professionalism, creative ideas and approach to handling complicated legal disputes, as well as finding fast and accurate solutions.’

‘The law firm is our preferred legal advisor because of its excellence in providing legal services tailored to our specific needs and because of the team of professionals in different fields. I believe this is one of the strongest law firms on the market, which is especially good in healthcare matters.’

Principaux clients

Acibadem City Clinic Tokuda Hospital


Acibadem City Clinic University Hospital


Bul Med Investment AD


Hill Clinic


Institute for Medical Research ООD


MBAL City Clinic Sveti Georgi


MBAL Doverie


MBAL Evropa


MBAL Uni Hospital


On Clinic


Recordati S.p.A.


Roche Bulgaria


SGP Bio Dynamics Ltd.


Principaux dossiers


  • Representing Acibadem in two court proceedings against the Bulgarian National Health Insurance Fund (NHIF) for the termination of a clinical trial contract with the NHIF for the treatment of cancer patients with radiosurgery and for the refund of amounts paid from the NHIF to the hospital for the treatment of cancer patients.
  • Acting for Acibadem City Clinic University Hospital in an appeal against a decision taken by the first-instance court in favour of the hospital in a claim against the NHIF for the payment of medical services.
  • Representing the Multi-profile Hospital for Active Treatment (MHAT) in claims against the NHIF for unpaid medical activities and medical products.

Kambourov & Partners

Kambourov & Partners' multidisciplinary healthcare, life sciences and pharmaceuticals practice encompasses regulatory and intellectual property advice, data protection and patient confidentiality issues, employment law, and corporate and M&A matters. The firm acts for healthcare providers, pharmaceutical companies, biotechnology firms and start-ups within the healthcare sector. Regulatory expert Ivo Alexandrov and employment and data protection specialist Andrey Alexandrov jointly lead the practice.

Responsables de la pratique:

Ivo Alexandrov; Andrey Alexandrov


Les références

‘I’m very satisfied with the partners I worked with from Kambourov & Partners. They answered my requests very quickly and demonstrated professional knowledge and engagement with my problems. I could easily reach them by mail or phone.’

‘Strengths of the team include cooperation, transparency, really good communication, dedication to work and respect for the client.’

‘They show outstanding communication with their clients. We are always informed and always in touch with them and they are a really good connection between our company and the authorities. They are precise, meticulous and effective.’

Principaux clients

Aetna Health Insurance Company of Europe DAC


Unilever


Sarepta Therapeutics


Dutchmed


End Insomnia LLC


Dentatechnica


Kartos Therapeutics


King’s Valley


Neogenesis


SofMedica


Dentotal


Dineras


Herbalife


Expur


National Institute of Geophysics, Geodesy and Geography, Bulgarian Academy of Sciences


Advantis


Principaux dossiers


  • Advised on the Bulgarian aspects of a multi-jurisdictional transfer of Aetna’s health insurance portfolio.
  • Successfully assisted Abris Capital Partners on its acquisition of Dentstore and subsequently continued to provide ongoing legal assistance to Dentstore in Bulgaria.
  • Advised Venture Equity, the majority shareholder in Almagest, on the negotiations and sale of Almagest to agricultural group Agria.

Komarevski Dimitrov & Partners, Attorneys-at-Law

Komarevski Dimitrov & Partners, Attorneys-at-Law‘s client portfolio includes pharmaceutical manufacturers, distributors, pharmacies, biotechnology companies and food manufacturers. The firm provides day-to-day assistance to longstanding clients such as AstraZeneca which covers regulatory, employment, data protection and pricing matters, and has recently advised on the distribution of medical supplies, structuring contracts and clinical trials. Ilya Komarevski leads the team and is frequently provides regulatory advice to clients as well as representation in court in regulatory appeals.

Responsables de la pratique:

Ilya Komarevski


Principaux clients

AstraZeneca


Takeda


Theramex


Mars and Royal Canin


Advent Group (Advent Life)


Novel Plant Foods


Hydrapharm Bulgaria


Merz Therapeutics GmbH


Principaux dossiers


  • Providing ongoing legal advice to AstraZeneca on all legal and regulatory matters and representing AstraZeneca in court in regulatory and labour disputes.
  • Providing ongoing legal advice to Takeda, including on post-merger integration with Shire, pricing and reimbursement matters, market placement of new drugs and pricing litigation.
  • Advising Mars, Inc. on a recurring basis on issues including, but not limited to, food, food supplements and pet food regulation in Bulgaria, and representation before the administrative authorities and courts in matters related to labelling, placing products on the market, product recalls and mandatory registrations.

Murgova & Partners Attorneys at Law

Murgova & Partners Attorneys at Law excels in the healthcare and life sciences field due to the specialised lawyers comprising the team. Practice co-head Petya Murgova has experience in public procurement procedures relating to pharmaceuticals, medical legislation and medical malpractice cases; she is supported by co-heads Alexander Stoimenov and Simeon Krastev. The team also frequently advises state hospitals, private healthcare companies and medical centres on clinical trial requirements and developing digital healthcare services.

Responsables de la pratique:

Petya Murgova; Alexander Stoimenov; Simeon Krastev


Autres avocats clés:

Eliza Dzhoneva-Georgakieva; Juliana Tsankova-Arsenova


Les références

‘The most important aspect of our mutual work is the availability, quick responses and willingness to help. With Murgova & Partners, the focus is on our partnership and on helping our business.’

‘I really appreciate the detailed and easy-to-understand explanations of the business implications of our cases. I value the high level of professionalism, honesty, and readiness to help. This applies to the whole team, especially Juliana Tsankova-Arsenova with whom I work more closely.’

‘I am impressed by the firm’s expertise in healthcare law, as well as the understanding of new technologies and opportunities for society.’

Principaux clients

Specialized Hospital for Rehabilitation


SAT Health


Vitania VR


Digital Health and innovations Cluster Bulgaria


My Synergy


Junior Achievement Foundation


Shemha Health


More Darzalas Foundation


SAT Health Care – Medical and Social Care Home


Principaux dossiers


  • Advised Digital Health and Innovations Cluster Bulgaria on a number of digital health projects in response to the changed health situation due to COVID-19.
  • Assisted the founders of COHM on its establishment and on day-to-day legal issues.
  • Advising JA Bulgaria and the Edge Research and Business Development on their successful pre-accelerator programme Beyond, focused on several key spheres including innovations and digitalisation in healthcare.

Penkov, Markov & Partners

Penkov, Markov & Partners is well versed in advising on the regulations surrounding medicinal products, clinical trials, the distribution of food supplements and healthcare products, enabling the team to assist clients ranging from small domestic companies through to multinational players with day-to-day matters. Roman Stoyanov leads the practice and extends the team's offering to include representation in pharma litigation and healthcare-related disputes.

Responsables de la pratique:

Roman Stoyanov


Autres avocats clés:

Ana Krusteva; Tihomir Tishev


Les références

‘Outstanding lawyers with great expertise and full commitment to the matter. Highly recommended!’

‘Roman Stoyanov is excellent to work with – he is always reachable and has very deep knowledge of the pharmaceutical sector.’

‘They are proactive – for any problem they offer you a range of solutions and help you understand which is the best one for you. They help with problem solving and give quick and competent feedback.’

Principaux clients

Pierre Fabre Bulgaria EOOD


Berlin-Chemie/A. Menarini Bulgaria EOOD


Berlin-Chemie AG/A. Menarini Research & Business Service GmbH


Fresenius Medical Care Bulgaria EOOD


SMTL Puldin Ltd.


NaturProdukt OOD


InnoPharma S.r.l., International Clinical Research Organization (CRO) and its Bulgarian subsidiary InnoPharma International BG


Anji Pharmaceuticals


Avanir Pharmaceuticals Inc.


Convex EOOD


Fidelis Research AD


UniBiomed OOD


Principaux dossiers


  • Advising Fidelis Research AD on the complex requirements of its assignors and of medical institutions, from both a legal and ethical perspective, in view of the lack of regulatory framework for the conduct of collecting and performing of analyses of biospecimens for research purposes.
  • Represented Naturprodukt OOD in proceedings before the National Council for Self-Regulation over allegations made by a competitor of violation of the rules on the advertising of food supplements.
  • Assisted Naturprodukt OOD with the launch of a new product line containing cannabidiol.

Schoenherr

Schoenherr leverages its presence in Central and Eastern Europe to advise a variety of clients, including healthcare and pharmaceutical companies and manufacturers and retailers of cosmetics, detergents and food, on cross-border M&A transactions, corporate financing, regulatory issues and e-health, as well as day-to-day legal matters spanning a number of practice areas. Elena Todorova leads the team and frequently advises food and pharma companies on compliance with the regulatory framework.

Responsables de la pratique:

Elena Todorova


Les références

‘They have a very professional approach and are client oriented – they are really good at understanding the specific client’s needs and not just providing abstract legal opinions. Great relationships with the authorities which provides the opportunity to check aspects that are not clear from a legislation perspective.’

‘Approachable, fast and hardworking. They are problem solvers.’

‘Elena Todorova is an amazing lawyer. She is always on time and provides perfect advice, aiming to support businesses. She coordinates international projects very well without any delay.’

Principaux clients

Queisser Pharma Bulgaria


Bulstrad Life


Home Medic


Schreiber Foods Bulgaria


Dimitar Madjarov


OMV


DentaTechnika


Amway


Dr. Oetker


RED Bull


KiK Textilien und Non-Food GmbH


Principaux dossiers


  • Advising on the acquisition of Home Medic by the SAT Health Group and the acquisition of Medical Center AmeriMed by the Bulstrad Life Vienna Insurance Group.
  • Advising KiK Textilien und Non-Food GmbH on the establishment of its local presence and on the regulatory aspects of its local business.
  • Advising Capital One Bank on the Bulgarian aspects of a USD 31m senior debt financing for Healthcare Components Group’s acquisition of American Optics – Endoscope Replacement Parts and Replacement Parts Industries.

Stoeva, Tchompalov & Znepolski

Multinational pharmaceutical manufacturers and distributers, as well as individual healthcare practitioners and pharmacists, make up Stoeva, Tchompalov & Znepolski‘s client roster. The team advises clients on new pharma regulations and public procurement procedures and provides ongoing legal support to long-term clients on corporate, commercial, labour and data protection matters. Irina Stoeva leads the practice and advises global pharma and healthcare companies such as GlaxoSmithKline and Perrigo.

Responsables de la pratique:

Irina Stoeva


Les références

‘The practice is incredibly attentive to all its clients. They are always available to chat about our concerns and always answer our questions in detail and in a timely manner. They are very experienced in the health sector and work with many companies in the field.’

‘They are the perfect team – they have complementary strengths and work in perfect harmony to provide us with the best legal assistance every time we need their help.’

‘Easy contact, good communication, quick and accurate consultations.’

Principaux clients

GlaxoSmithKline


Perrigo


Haleon


EU Pharmacia Bulgaria


SottoPelle


Sofia Regional Pharmaceutical Association


Ekan – Lubomir Subev


Periodontics and Oral Implantology Society


Adriatic D.O.O.


Medic X


Principaux dossiers


  • Advise British multinational consumer healthcare company Haleon on local regulatory requirements.
  • Advising Medik X Ltd, the official representative of Japanese company Kobayashi and its brands Cura Heat and Kool’n Soothe, which focuses on identifying, developing and distributing innovative health products.
  • Advised GSK Export Limited on the renewal of the distribution agreement for Rotarix with Phoenix Pharma.

Wolf Theiss

Wolf Theiss is well placed to advise clients across Central and Eastern Europe, including leading international pharmaceutical companies, clinical trial providers and manufacturers of medical devices, on various corporate, employment, real estate and data protection matters, as well as on cross-border acquisitions. Anna Rizova is the practice head and is supported by Hristina Dzhevlekova.

Responsables de la pratique:

Anna Rizova


Autres avocats clés:

Hristina Dzhevlekova


Les références

‘The Wolf Theiss team has showcased legal expertise and competence and a compassionate and supportive approach, which has been instrumental in maintaining harmony as we move forward.’

‘They were available to assist us whenever we reached out, even during unconventional hours, and were consistently just an email or phone call away. They provided support throughout all the court cases and their involvement has had a significant positive impact.’

Principaux clients

Intuitive Surgical Operations


STS Medical Group


Edgecap Partners


Eli Lilly


Arcema


Pet Network International


Principaux dossiers


  • Advising Swiss company Intuitive Surgical on the development of a EUR 40 million investment in a highly sophisticated manufacturing facility in South Bulgaria.
  • Advising EdgeCap on the acquisition of the majority interest in Comac Medical.
  • Advising European pet care retail group Pet Network on the acquisition of the leading Bulgarian veterinary retail chain Dr Stefanov.