Healthcare and life sciences in Bulgaria

Boyanov & Co.

Boyanov & Co. boosts an enviable roster of multinational pharma clients, such as Pfizer, Sanofi Group, Bayer and Novartis, to name a few, and handles a broad range of mandates, from IP protection and patent litigation to market access and antitrust issues. Practice co-leader and regulatory specialist Peter Petrov is praised for his ‘diverse knowledge and deep understanding of the healthcare and life sciences industry’, while practice co-leader Kina Chuturkova represents pharma clients in litigation proceedings, including in cases on the prosecution and enforcement of IP rights.

Practice head(s):

Kina Chuturkova; Peter Petrov

Other key lawyers:

Nedyalka Novakova

Testimonials

‘Peter Petrov is an exceptional legal professional with diverse knowledge and deep understanding of the healthcare and life sciences industry.’

‘If the case is related to a specific topic, the law firm provides additional advice to meet the needs. The guidelines we receive are professionally prepared, with a perfect balance between the importance of the problem and the procedures and codes – thus we get adequate solution-based answers on the local law and internal procedures, while maintaining professional relationships with our clients, including health care professionals, patient organisations etc.’

Key clients

Sanofi Group companies

Neola Pharma

Actelion Pharmaceuticals

F. Hoffmann La Roche

AbbVie

Shire

ARPharM Bulgaria

Bayer

Novartis

GSK

Pharmaceutical Research Associates

Celgene Corporation

Merck

Medtronic

PharmArt Enterprises

Meril Life Sciencies

Pfizer Bulgaria

Anika Therapeutics

Servier

Vertex Pharmaceuticals

Work highlights

  • Advising the Association of Research-based Pharmaceutical Companies in Bulgaria (ARPharM) on drafting and proposing legislative amendments aimed at speeding up and facilitating market access for innovative therapies by introducing deadlines in which the Bulgarian public health insurance scheme (NHIF) should issue the guidelines necessary for the application and reimbursement of these therapies.
  • Engaged by Pfizer to provide advice on a variety of regulatory issues relevant to Pfizer’s Bulgarian operations.
  • Representing F. Hoffmann-La Roche in all aspects related to the management of their patent portfolio in Bulgaria.

Dimitrov, Petrov & Co

Dimitrov, Petrov & Co advises its list of notable clients, including Johnson & Johnson, Pfizer and Eli Lilly, on the full spectrum of day-to-day matters, projects and has demonstrable experience in administrative and court proceedings. The team is well-placed to leverage the expertise of other departments across the firm when advising pharma companies on IP, commercial, competition and data protection matters. Practice leader and head of the firm’s IP department, Biliyana Angelova, is supported by regulatory and corporate partner Zoya Todorova.

Practice head(s):

Bilyana Angelova

Other key lawyers:

Zoya Todorova; Asya Vladimirova; Encho Simeonov; Martin Zahariev

Testimonials

‘I would recommend Bilyana Angelova for her in-depth knowledge of the regulatory framework and strength in IP matters.’

Key clients

Pfizer Luxemburg, Bulgaria Branch

Johnson & Johnson Bulgaria/Janssen-Cilag International

Eli Lilly (Suisse)

Upjohn Export B.V.

Specialized Pediatric Hospital for Active Treatment

Zonapharm and Zona Pharma

PMA – Pharma Marketing Advisors

Second Hospital of Obstetrics and Gynaecology Sheinovo

Progen

BBA Ecotech

Ergomed

Work highlights

  • Providing complex and day-to-day support to the Bulgarian subsidiary of Pfizer Luxembourg.
  • Providing regular advice on a variety of matters to Johnson & Johnson Bulgaria.
  • Successfully defended Progen in a dispute over the application of personal data protection rules in processing genetic data.

Djingov, Gouginski, Kyutchukov & Velichkov

Praised as a ‘top-tier practice for healthcare and life sciences’, Djingov, Gouginski, Kyutchukov & Velichkov acts for well-known pharma companies on all aspects of their operations in Bulgaria, from corporate, regulatory and commercial matters to dispute resolution and IP issues. ‘Tenacious’ partner Kalina Tchakarova leads the pharma regulatory practice and has well over two decades of experience advising on advertising and distribution of medicinal products and IP protection, including patent validity and infringement mandates. Recent client gains include Pharmascience and Novartis Pharma Services, among others.

Practice head(s):

Kalina Tchakarova

Other key lawyers:

Valentin Bojilov

Testimonials

‘Djingov, Gouginski, Kyutchukov and Velichkov is a top-tier practice for healthcare and life sciences practice. Their team understands a client’s priorities and business and shows determination in finding the most suitable range of solutions. They have a large and resourceful team they can easily deploy if needed, so that even the most complicated matters are dealt with in a timely fashion.’

‘Kalina Tchakarova is a super-reliable and accessible partner with deep market knowledge. She is tenacious, calm, with a fine-tuned commercial sense and an amazing attention to details. You cannot ask for a better healthcare and life sciences lawyer.’

Key clients

Advanced Sterilization Products (ASP)

Pierre Fabre Dermo-Cosmetique

Kyowa Kirin International

CSL Behring

Medison Pharma Trading

Merck Bulgaria

Pharmascience

Swedish Orphan Biovitrim

Novartis Pharma Services Inc.

Astellas Pharma

Work highlights

  • Advising Aspen Europe and its local subsidiary on an ongoing basis, including on general corporate and regulatory matters.
  • Assisted Pharmasciece on ongoing pharmaceutical regulatory matters, related to pricing and reimbursement of generic pharmaceutical products, as well as intellectual property implications in the field.
  • Advising Swedish Orphan Biovitrum in relation to all pharmaceutical matters that the company deals with in Bulgaria, such as the localisation of HCC agreements, corporate matters and pharmaceutical compliance.

CMS

The multidisciplinary team at CMS acts for clients across the pharmaceutical, biotechnology and medical devices industries on a range of matters, including corporate and M&A transactions, commercial contracts, IP and data protection and regulatory issues, among others. Counsel Anna Tanova jointly leads the practice alongside partner Assen Georgiev, following the departure of senior associate Angelika Sedlackova in April 2021 to Kyowa Kirin International. The team provides ongoing commercial advice to key client Johnson & Johnson.

Practice head(s):

Assen Georgiev; Anna Tanova

Key clients

Johnson & Johnson

Work highlights

  • Advising Johnson & Johnson on a wide range of commercial matters, including personal data protection, regulatory law, commercial, review of contracts as well as on the setting up and conduct of clinical trials and non-interventional studies in Bulgaria.

Deloitte Legal Law Firm

Deloitte Legal Law Firm utilises its full-service capability to act for clients across the pharma and healthcare sectors on regulatory and corporate matters, as well as personal data protection, tax, contractual and employment issues. Renata Petkova jointly leads the practice alongside managing associate Miglena Milcheva, who has 17 years’ experience advising domestic and multinational pharma companies on a range of mandates, such as distribution of medicines and regulatory compliance.

Practice head(s):

Reneta Petkova; Miglena Micheva

Georgiev, Todorov & Co

Georgiev, Todorov & Co delivers an ‘unparalleled service’ to clients across the pharma and healthcare sectors, including major hospitals, pharmaceutical and cosmetics companies, when it comes to strategically significant disputes. The team, which also advises on regulatory, corporate and IP matters, successful defended Balkam Group against an alleged unfair competition claim before the Commission for Protection of Competition. Managing partner Ivan Todorov leads the practice and is supported by Tsvetelina Dimitrova, Mariya Derelieva and associate Margarita Ivanova.

Practice head(s):

Ivan Todorov

Other key lawyers:

Tsvetelina Dimitrova; Mariya Derelieva; Margarita Ivanova

Testimonials

‘Ensuring compliance with the increasingly complex and pervasive nature of regulation in the healthcare sector requires expert advice and support. Our collaboration with Prof. Ivan Todorov, Ms. Maria Derelieva and Ms. Margarita Ivanova have proven excellent results when clear and decisive advice is required. We continuously receive seamless advice, and our legal problems are analysed from every necessary angle. These exceptional professionals provide a prompt, proactive and timely service in various difficult cases.’

‘The team of Georgiev, Todorov & Co. understand the details of the business, they have a consistent and sustainable approach towards the needs of the client. At all stages, the legal team is involved hands-on with our case, thus delivering unparalleled service.’

‘Our team mainly works with the recently appointed partner Tsvetelina Dimitrova and associate Margarita Ivanova. Tsvetelina is hard-working and client oriented. Margarita has an eye for detail and creative methods of solving legal issues. Pharmaceutical law and healthcare are some of her specialisms, she really enjoys working in the field, and that helps her have additional knowledge and an interesting viewpoint for most of our questions.’

‘We think what makes this practice unique is the well-grounded people and professionalism.’

‘The team is very dedicated, and all of the team know everything about the case. No matter who I discuss the matter with, they are all well prepared. They do not hesitate to ask about all details, including outside of the case itself, so they can understand deeply the scope of the businesses and thus defend it.’

Key clients

Acibadem City Clinic Tokuda Hospital

Acibadem City Clinic University Hospital

Bul Med Investment

Hill Clinic

Institute for Medical Research

Liulin Hospital

MBAL City Clinic Sveti Georgi

MBAL Doverie

MBAL Evropa

MBAL Uni Hospital

On Clinic

Recordati

Roche Bulgaria

SGP Bio Dynamics

Work highlights

  • Successfully defended on three instances several hospitals from the Acibadem City Clinic Group (including Tokuda and University Clinic) against the National Health Insurance Fund (NHIF) concerning payments for medical care provided to health-insured patients above the limits set by the NHIF for approximately €8m.
  • Representing Bul Med Investment against a court claim filed by the Ministry of Healthcare in relation to a non-fulfilment of a contract for a public procurement procedure for hospital equipment with penalties of approximately €2.8m claimed.
  • Advising Institute for Medical Research on a dispute with a German company in relation to the conduct of medical genetic research for detection of genetic mutations in cancer patients and the execution of the contract concluded.

Kambourov & Partners

The multidisciplinary practice at Kambourov & Partners focuses on start-up undertakings and innovative provider outlets in the healthcare sector and covers the full range of matters, including regulatory issues, employment, competition, corporate transactions, IP rights and patient confidentiality. ‘Standout partners’ include practice co-leaders Andrey Alexandrov, who advises stakeholders in the pharma and healthcare sectors on ‘employment, personal data protection and regulatory’ issues, and Ivo Alexandrov, who ‘covers regulatory and finance matters’. The team often acts as local partner to international firms to advise on the Bulgarian aspects of transactions.

Practice head(s):

Ivo Alexandrov; Andrey Alexandrov

Other key lawyers:

Yana Todorova; Mario Arabistanov

Testimonials

‘The practice covers every aspect of the operations of any stakeholder in the healthcare industry, including regulatory, competition, intellectual property, corporate, commercial, tax, finance, employment, litigation. This makes it a one stop legal shop for any healthcare business and as a client, gives you the reassurance that any matter can be handled expertly regardless of its legal nature. The team has very deep insight and all-round knowledge of the healthcare sector, as well as a strong commercial focus. They are remarkably results and client-oriented, approachable and consistently attentive and supportive.’

‘Strong life sciences practice in Bulgaria.’

‘Much can be said about the things that make the individuals stand out such as their immense knowledge, experience, business sense, deep professionalism. They are also some of the most thorough and dedicated professionals I have met. They stay on top of things, consistently reinventing and improving themselves to adequately respond to the ever changing market conditions. Standout partners include co-heads of the healthcare practice, Ivo Alexandrov and Andrey Alexandrov. Ivo covers regulatory and finance matters, while Andrey focuses on employment, personal data protection and regulatory. I’d highly recommend both of them.’

Key clients

Takeda Pharmaceuticals International

Merck

Beam Suntory

Sarepta Therapeutics

Clinic Design

Four Paws Foundation

Kaufland Bulgaria

Unilever

Chivas Holding Limited

Argenx

Advantis

Prestige-96

Kamenitza

Axis

Huvepharma/Biovet

Herbalife

Specialised Hospital for Active Treatment in Obstetrics and Gynecology Selena

Syneos Health

Work highlights

  • Represented Specialised Hospital for Active Treatment in Obstetrics and Gynecology Selena as a respondent in proceedings before the Bulgarian competition authority and subsequently was retained to advise and assist on the sale of Selena University Specialised Hospital.
  • Advised on certain regulatory and compliance aspects of Merck’s operations in Bulgaria.
  • Advised Takeda Pharmaceuticals on various aspects of the Bulgarian pharmaceuticals legislation.

Murgova & Partners Attorneys at Law

Murgova & Partners Attorneys at Law advises its impressive roster of clients, including state hospitals, private healthcare companies and medical centres, on clinical trials, public procurement procedures for medical products, cases concerning medical malpractice, in addition to general day-to-day matters. The team is known for having a ‘strong focus in the healthcare sector with dedicated partners’, including managing partner Petya Murgova, who has over 15 years’ experience in this sector, and recommended practitioner Silvana Dzharkova-Aleksandrova. Both lead the practice group alongside senior associate Alexander Stoimenov.

Practice head(s):

Petya Murgova; Alexander Stoimenov; Silvana Dzharkova-Aleksandrova

Other key lawyers:

Simeon Krastev; Eliza Georgakieva

Testimonials

‘Strong focus in the healthcare sector with dedicated partners. Regular exchange of opinions with healthcare professionals, participation in healthcare forums. With me, the main partner Petya Murgova maintains regular monthly calls with emphasis on what’s new and what’s main topic of healthcare sector in Bulgaria. Very nice weekly bulletin with coverage of hot topics of the business and regulatory environment of Bulgaria.’ 

‘The managing partner Petya Murgova could be defined as a leading lawyer in the healthcare sector in Bulgaria. Her exceptional knowledge of the sector, applicable Bulgarian and EU legislation and extensive experience is crucial for us in order to be fully compliant with all regulatory requirements. We are very impressed by her professional approach to specific medical issues and her active participation in amendments of the local legislation framework. We could also recommend Simeon Krastev and Eliza Dzhoneva, who support our company in all aspects concerning the specific healthcare services. Mrs. Dzhoneva is a very confident, flexible, effective professional, who has impressive knowledge in the field of data protection regulation. Her expertise in public procurement supports our company in order to meet all the requirements and criteria of the national legislation. Mr. Krastev is always available and his timely advice supports us in our daily activity. We highly appreciate the team’s creative solutions on complex matters in the healthcare sector and administrative requirement for using natural, mineral and climatic resources for our medical procedures.’ 

‘We have used the services of Murgova and Partners Attorneys at Law for a long time and could undeniably say that they are trustworthy professionals who have become our trusted legal advisors on all cases in this specific area. The law firm helps us with legal advice and analysis concerning the healthcare regulations and legal framework. Murgova and Partners are always innovative when it comes to their expert advice. We appreciate how they always keep their clients informed about changes of framework, current legal issues, opportunity to apply for state aid etc., which they do through their weekly articles and newsletter, both very beneficial to our business.’ 

‘This practice is always solution-orientated and very focused and available to serve the customer. They have a great attitude with clients.’ 

‘We consider Murgova and Partners’ team as highly professional, always providing very accurate and timely legal services. First, we could point out the managing partner, Ms. Petya Murgova, who impresses us every time with her confidence and knowledge of all legal matters. Due to her continuous practical experience, negotiation skills and vast expertise she is capable of adequate reactions in each unexpected situation. Petya always looks at every angle, which makes her my top and best lawyer in the area of life sciences and dispute resolution. With her knowledge the client is always well informed how to choose the tactic which will make the case succeed. Very accessible and gives clients a lot of confidence. The other two members we could recommend are Ms. Silvana Dzharkova-Aleksandrova and Ms. Eliza Georgakieva. They both stand out as extremely prepared practitioners, always very responsive and providing advice strictly on time, which adds a great value the provided legal services and assistance.’ 

‘Personable, professional, punctual, innovative and caring.’ 

Key clients

Specialized Hospital for Rehabilitation

SAT Health

Vitania VR

Digital Health and innovations Cluster Bulgaria

My Synergy

Work highlights

  • Advised Digital Health and Innovations Cluster Bulgaria under number of digital health projects in response to the changed health situation due to COVID-19.

Penkov, Markov & Partners

Penkov, Markov & Partners advises domestic and multinational pharmaceuticals, healthcare companies, medical device manufacturers and food supplement distributors on a range of regulatory, corporate and compliance matters. Practice leader Roman Stoyanov has over 17 years’ experience in pharma litigation and representing market authorisation holders (MAHs) before government authorities and the courts. Praised for its ‘great knowledge in clinical trials’, the team also includes associate Ivo Nickolchev, who is able to draw on his previous experience at a clinical research organisation (CRO). Other key members include associates Ana Krusteva and Svetla Ivanova.

Practice head(s):

Roman Stoyanov

Other key lawyers:

Ivo Nickolchev; Ana Krusteva; Svetla Ivanova

Testimonials

‘Brilliant legal knowledge, as well as understanding of and great commitment to the client’s needs.’

‘Roman Stoyanov was diligent and thorough in his comments despite short turnaround time. Would not hesitate to recommend to work with him again.’

‘Great knowledge of clinical trials.’

‘We appreciate very much the availability of Roman Stoyanov in the management of every single request on our part, the commitment and dedication he puts in to help us solve problems and recommend the best solutions for our company.’

Key clients

Pierre Fabre Dermo

Berlin-Chemie/A.Menarini Bulgaria

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

InnoPharma/InnoPharma International BG

NaturProdukt, affiliate of Dr. Theiss Naturwaren

Anji Pharmaceuticals

Avanir Pharmaceuticals

Cannabiall Trade

Bless Medical

Medical Center Mona Lisa

Work highlights

  • Representing Berlin-Chemie/A. Menarini Research & Business Service GmbH on a case concerning parallel import of medicinal product of a MAH belonging to the same group.
  • Assisting Pierre Fabre Dermo-Cosmetique Bulgarie in its relations with the state authorities in the process of negotiating of obligatory discounts for the medicines, the appliance of the mechanism for providing of foreseeability and sustainability of the NHIF, as well on various regulatory aspects.
  • Advising Naturprodukt/Dr. Theiss Naturwaren regarding manufacturing in China of a diet food supplements.

Schoenherr (in cooperation with Stoyanov & Tsekova)

Attorney Elena Todorova leads the cross-practice healthcare and life sciences team at Schoenherr (in cooperation with Stoyanov & Tsekova) and is praised for her ‘business-oriented capability to provide efficient legal advice in a timely manner’. The practice is well-placed to handle a range of matters, as demonstrated by advising food producer Dimitar Madzharov on creating an innovative meat products brand, as well as matters of unfair competition and consumer protection issues. Todorova also acts for pharmaceutical companies, producers and distributors of medicinal products and medical devices, among others.

Practice head(s):

Elena Todorova

Testimonials

‘Elena Todorova is very knowledgeable in food law. She is responsive and provides practical advice.’

‘Extremely professional and well-versed in all aspects of healthcare and life sciences, which is rare to find on the Bulgarian market.’

‘Great team that possesses all the necessary expertise to deliver accurate and timely legal advice and anticipate the client’s needs and issues.’

‘Elena Todorova has solid knowledge of the food law sector and a business oriented capability to provide efficient legal advice in a timely manner.’

‘Very professional law firm with excellent knowledge of complex food law issues and constantly updated lawyers, who are active participants in several food law-related unions and scientific communities.’

Key clients

Dimitar Madjarov

OMV

Pharma Vision Europe

Amway

Taisho Pharmaceutical Co.

Dr. Oetker

RED Bull

Work highlights

  • Advising Dimitar Madzharov on the creation of an innovative meat products brand, food law, matters of unfair competition and consumer protection law on a regular basis.
  • Advised Amway on their market entry into Bulgaria and the subsequent regulatory, e-commerce and legal compliance matters.
  • Advising OMV on consumer protection and food law-related issues.

Stoeva, Tchompalov & Znepolski

Stoeva, Tchompalov & Znepolski counts multinational pharmaceutical producers, distributors, as well as individual healthcare practitioners and pharmacists, among its roster of key clients; the team handles public procurement procedures, healthcare disputes and regulatory and compliance matters. Irina Stoeva leads the practice group and acts for notable clients including GlaxoSmithKline and Perrigo, on account of her 21 years of experience in this sector. Of counsel Vania Todorova and senior associate Miroslava Iordanova are key members of the team.

Practice head(s):

Irina Stoeva

Other key lawyers:

Vania Todorova; Miroslava Iordanova

Testimonials

‘Irina Stoeva is an outstanding lawyer with impressive knowledge and experience in healthcare and commercial litigation. She is very responsive, business-oriented, flexible and persuasive. Due to her business-oriented, practical approach we have succeeded in reaching, in my view, the optimal outcome in several commercial cases. Additional STZ team-members to praise are Vania Todorova and Miroslava Iordanova, both very knowledgeable, dedicated and precise lawyers.’ 

‘This is a team of excellent lawyers, who perfectly collaborate and provide back-up to each other. They always respond on time and with high quality work.’

‘I have worked with Mrs. Irina Stoeva for more than 15 years. During these years, I have always relied on her professional legal advice. She has excellent knowledge of commercial law, as well as the legal framework of many industry areas (i.e., pharmaceutical industry, insurance. etc.). Following her legal advice and legal representation provides a successful outcome for her clients in very complicated cases.’

Key clients

GlaxoSmithKline

Perrigo

EU Pharmacia Bulgaria,

Sofia Regional Pharmaceutical Association

Ekan – Lubomir Subev

Periodontics and Oral Implantology Society

Adriatic

Dr. Mark Danan

Medik X

Work highlights

  • Advised GlaxoSmithKline in relation to the change in Bulgaria of the commercial model and the outsourcing of the distribution, promotion and market access activities for the group pharmaceutical products to the new local partners.
  • Advising EU Pharmacia Bulgaria on regulatory issues related to the registration of a food supplement with Bulgarian Food Safety Agency.
  • Advising members of the RPAS on transferring their retail permits and business activity and obtaining approval from Bulgarian Drug Agency.

Tsvetkova Bebov & Partners

Tsvetkova Bebov & Partners advises multinational clients across the pharmaceutical and food sectors, including manufacturers and distributors, on day-to-day activities ranging from regulatory issues to pricing and reimbursement matters. The practice group boasts an impressive client list and acts for well-known companies such as AstraZeneca, Takeda and Mars. Managing partner Irina Tsvetkova jointly leads the team, which includes senior associate Philip Kiossev, alongside managing associate Eleonora Mateina, following the departure of Ilya Komarevski  in September 2021.

Practice head(s):

Irina Tsvetkova; Eleonora Mateina

Other key lawyers:

Philip Kiossev

Testimonials

‘Philip Kiossev has been excellent. His advice has been clear and helpful and he is very responsive.’

‘Innovative and open-minded thinking, quick and confident reaction, understanding of business needs, flexible and responsive.’

Key clients

AstraZeneca

Takeda

Mars and Royal Canin

Applied Molecular Transport Inc.

Podravka

Advent Group

IQVIA

Work highlights

  • Advising AstraZeneca Bulgaria on an ongoing basis, including regulatory, pricing and reimbursement, ethical, commercial, employment, personal data protection and other matters.
  • Advising Takeda on an ongoing basis, including regulatory, pricing and reimbursement matters, and currently, in relation to early access of new medicinal products on the Bulgarian market.
  • Advising Mars on an ongoing basis, on food, food supplements and pet food regulation in Bulgaria, representation before administrative authorities and courts on matters related to labelling claims, placing products on the market, product recalls and mandatory registrations.

Wolf Theiss

The team at Wolf Theiss handles a wide range of mandates, from procurement and financing to licensing and corporate, and is advising biopharmaceutical company Celgene International Sàrl on compliance requirements and regulatory matters in regarding its business in Macedonia and Bulgaria. The team also acts for international R&D and generic pharma companies, including Eli Lilly, as well as clinical trials’ providers and medical devices manufacturers. Managing partner Anna Rizova, who focuses on antitrust and competition issues in the pharma and healthcare sectors, leads the practice group, which includes counsel Hristina Dzhevlekova.

Practice head(s):

Anna Rizova

Other key lawyers:

Hristina Dzhevlekova

Key clients

Eli Lilly Romania SRL

Celgene International Sàrl

Work highlights

  • Advising Pfizer HCP on certain local aspects upon the merger of their UpJohn division with Mylan.
  • Advising on local corporate and other aspects of the separation of Merck into two divisions, MSD and Organon, with related local procedures and filings.
  • Providing support on corporate governance and litigation to IQVIA.