Healthcare and life sciences in Bulgaria

Boyanov & Co.

Peter Petrov and Kina Chuturkova make a strong duo at Boyanov & Co. with their respective expertise in regulatory matters and dispute resolution. The practice is also backed by a premier corporate team for high-level transactions within the healthcare and life sciences sector and excels in the intellectual property aspects so vital to the industry. The firm's enviable client roster includes Sanofi Group, Bayer, Novartis and GlaxoSmithKline, as well as AbbVie, which it advised on an advanced direct-to-pharmacy distribution system for a new-to-market pharmaceutical product.

Practice head(s):

Kina Chuturkova; Peter Petrov

Other key lawyers:

Nedyalka Novakova

Key clients

Sanofi Group companies

Neola Pharma

Actelion Pharmaceuticals

Hoffmann La Roche

Alcon

AbbVie

Shire

ARPharM Bulgaria

Bayer

Novartis

Mylan

GSK

Pharmaceutical Research Associates

inVentiv Health Bulgaria

CST Pharma

Celgene Corporation

Merck

Medtronic

PharmArt Enterprises

Work highlights

  • Advised AbbVie on the structure and operation of an advanced direct-to-pharmacy distribution system for an innovative pharmaceutical product, introduced to the Bulgarian market for the first time.
  • Acted for Advent/Zentiva on the merger control aspects of its acquisition of the CEE business of rival Alvogen.
  • Supported the Association of the Research-based Pharmaceutical Industry (ARPharM) in Bulgaria in challenging a proposed legislative amendment requiring mandatory biosimilar substitution. The legislative proposal was ultimately abandoned due to its potential market-distorting effect.

Dimitrov, Petrov & Co

A truly deep offering in the healthcare and life sciences sector is provided by Dimitrov, Petrov & Co due to the firm's 'real in-depth knowledge of the pharma and medical devices sector and the regulatory framework governing it.' Biliyana Angelova heads the IP and life sciences group and leads on many of the key mandates. She is supported by leading corporate and regulatory partner Zoya Todorova and experienced associates Asya Vladimirova  and Encho Simeonov. Pfizer, Johnson & Johnson and Eli Lilly instruct the firm and Gedeon Richter is a recent gain.

Practice head(s):

Bilyana Angelova

Other key lawyers:

Zoya Todorova; Asya Vladimirova; Encho Simeonov

Testimonials

‘They have real in-depth knowledge of the pharma and medical devices sector and the regulatory framework governing it. They follow the legal developments closely and assist the Bulgarian government with the drafting of laws in this field so have valuable knowledge.’

‘I have worked with Zoya Todorova, Bilyana Angelova and Asya Vladimirova. All are excellent: professional, efficient and they provide practical advice.’

‘The entire team is committed to helping the client and taking care of all the details; the client feels cared for and well informed about the case and the principles of cooperation which is much appreciated.’

‘Bilyana Angelova provides prompt reaction and profound insight into the case.’

‘Recommended for their promptness in reply and great analysis and inspection of any issue.’

‘The team’s strengths include high level of responsibility, loyalty, and professionality. Bilyana Angelova supports us 24/7 on a wide range of cases.’

‘DPC’s reputation in the area of medical malpractice cases is impeccable. Their experts have demonstrated great knowledge in the specific area of medical disputes and proved to be very good litigators. Their expertise and responsiveness give us the confidence that we receive the best professional and cost-effective business advice. This year the DPC team successfully closed a complex case about alleged medical malpractice involving civil and penal aspects with significant material interest.’

‘Our main contact at the firm is Encho Simeonov. He is a brilliant litigator, who combines long-term practical experience with a strategic mind when it comes to complex disputes. He is reliable, always available and loyal.’

Key clients

Pfizer Luxemburg, Bulgaria Branch

Johnson & Johnson Bulgaria/Janssen-Cilag International

Eli Lilly (Suisse)

Boehringer Ingelheim RCV GmbH & Co KG – Bulgarian Branch/Boehringer Ingelheim Austria

Gedeon Richter

Specialized Pediatric Hospital for Active Treatment – prof. Ivan Mitev EAD

Olam Polska

BBA Ecotech

Ilea – M

Zonapharm and Zona Pharma

PMA – Pharma Marketing Advisors

Genetic medico-diagnostic laboratory Genica

Second Hospital of Obstetrics and Gynaecology Sheinovo

Progen

Work highlights

  • Providing legal support to the Bulgarian subsidiary of Pfizer.
  • Advising Johnson & Johnson Bulgaria on a variety of matters.
  • Performing an overall legal and healthcare compliance review on behalf of Boehringer Ingelheim, and producing a comprehensive report of the local entity’s interactions with healthcare professionals, healthcare organisations and patient organisations.

Djingov, Gouginski, Kyutchukov & Velichkov

Djingov, Gouginski, Kyutchukov & Velichkov fields 'one of the strongest teams in Bulgaria', earning an extensive and elite client base in the healthcare and life sciences sector. Recent instructions include dispute resolution on behalf of Merck & Co. and representing General Electric Healthcare in public procurement tenders to supply medical devices to the Ministry of Health and state-owned and municipal hospitals. Kalina Tchakarova is a leading figure with over 20 years' experience providing regulatory advice to pharmaceutical companies, healthcare providers and producers and others.

Practice head(s):

Kalina Tchakarova

Other key lawyers:

Valentin Bojilov

Testimonials

‘One of the strongest teams in Bulgaria. Full-service law firm with a multidisciplinary approach.’

‘Kalina Tchakarova is the relationship partner. Always available, always prompt. Very clear in her advice.’

Key clients

Abbott Laboratories Europe

Acibadem City Clinic (former Tokushukai-Sofia)

Actavis

Akros Pharma

Alcon Bulgaria

Aspen Pharmacare Holdings Limited

Astellas Pharma Europe

Baxter International

Beiersdorf

Berlin-Chemie

Cardinal Health

Cargill Bulgaria

ClinTec International

Coca-Cola Enterprises

Covance Clinical and Periapproval Services

Dow Deutschland

EU Pharmacia Bulgaria

Fater (JV owned by Procter & Gamble and Angelini Group)

Froneri Bulgaria

General Electric Healthcare

Laboratory Corporation of America Holdings (LabCorp)

Merck Bulgaria

Red Bull

Samsung Bioepis

The Body Shop International

Work highlights

  • Advising General Electric Healthcare on its participation in various public procurement tenders by the Ministry of Health and state-owned/municipal hospitals for the supply of medical devices.
  • Providing  comprehensive day-to-day advice to Merck & Co. including regulatory matters, relationship with the National Health Insurance Fund and dispute resolution.
  • Advising Astellas Pharma Europe on the procedures for pricing and reimbursement of medicinal products in the country, and in various competition, employment and data protection matters.

Tsvetkova Bebov Komarevski

Tsvetkova Bebov Komarevski's life science practice rests on two specialist pillars: pharmaceuticals and medical devices, and foodstuffs, food supplements and cosmetics. Consequently it attracts stellar clients from both the pharma and food industry, such as AstraZeneca, Takeda, Lidl and Mars. Versatile partner Iliya Komarevski is recognised for his expertise and leads on key instructions, including advice to Takeda in respect of new medicinal products on the Bulgarian market. Senior associate Eleonora Mateina is an emerging name in the field and plays a key role in the practice.

Practice head(s):

Ilya Komarevski

Other key lawyers:

Eleonora Mateina

Key clients

AstraZeneca

Takeda Pharmaceutical Company

AmGen

Promedica24 Care

Association of Research–based Pharmaceutical Manufacturers in Bulgaria (ArPharm)

Polpharma (Zakłady Farmaceutyczne Polpharma)

Berlin Chemie

Lidl

Mars, Wrigley and Royal Canine

Work highlights

  • Advising ArPharm, the innovative pharmaceuticals association, on the establishment of a local entity (organisation for verification of medicinal products) as a part of the implementation of the relevant EU Directive.
  • 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 AstraZeneca Bulgaria on an ongoing basis, including regulatory, pricing and reimbursement, ethical, commercial, employment, personal data protection and other matters.

CMS

CMS fields a multidisciplinary team within its life sciences group which provides a comprehensive service to the industry comprising advice on clinical trials, distribution models, corporate matters and M&A, commercial contracts, competition, IP and data protection, regulatory issues and dispute resolution. Clients include some major names in the pharmaceutical, biotechnology and medical devices industries, such as Johnson & Johnson, which the firm has been advising on the establishment of clinical trials in Bulgaria. Disputes partner Assen Georgiev  and senior associate Angelika Sedlackova lead the practice.

Practice head(s):

Assen Georgiev; Angelika Sedlackova

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 the setting up and conduct of clinical trials in Bulgaria.

Deloitte Legal Law Firm

Clients rate the industry knowledge at Deloitte Legal Law Firm, which acts for a number of pharma and healthcare clients on a broad spectrum of issues, from corporate and regulatory advice to distribution agreements, data protection and anti-money laundering compliance. Recent work includes liaising with the Bulgarian Drug Agency regarding wholesale pharmaceutical licensing for a new entrant to the market. Managing associate Miglena Milcheva has 15 years' experience in the field and co-leads the practice alongside partner Renata Petkova.

Practice head(s):

Reneta Petkova; Miglena Micheva

Testimonials

‘Industry knowledge, pro-activity.’

‘Miglena Micheva is approachable, experienced and responsible.’

Georgiev, Todorov & Co

Georgiev, Todorov & Co excels in high-level disputes which are often of strategic importance to the healthcare market. Recently, it acted  for Acibadem City Clinic Tokuda Hospital in a dispute with the National Health Insurance Fund (NHIF) concerning payments to health-insured patients above limits set by the NHIF. Ivan Todorov and his team also handle a wider scope of work, including corporate, regulatory, advertising and licensing matters. Mariya Derelieva and Tsvetelina Dimitrova were promoted to partner in 2020 and lead on several work highlights.

Practice head(s):

Ivan Todorov

Other key lawyers:

Mariya Derelieva; Tsvetelina Dimitrova

Testimonials

‘The team works in great synergy, they are most-knowledgeable about the healthcare sector and provide groundbreaking ideas on our complex issues.’

‘Ivan Todorov,  Maria Derelieva and Margarita Ivanova have been assigned to work closely with our group. They keep pace with evolving legal, business and technological arenas.’

‘We have trusted Georgiev, Todorov & Co as our legal advisor since we established our presence in Bulgaria. Our company has chosen to work with the law firm because of their high success rate in litigation, their experienced professionals and excellent reputation on the market. All lawyers are really dedicated to their work, with outstanding negotiation skills and an eye for detail. They also have professionals who specialise in healthcare and pharmaceutical law, which allows them to understand our issues better, explain them to us in a straightforward manner and reach the best possible solutions.’

‘Our main lawyer at Georgiev, Todorov & Co is Tsvetelina Dimitrova. She is hard-working and client-oriented. Tsvetelina also has extensive knowledge of EU and international law regulations, which was essential for solving our legal issues at the time of a global pandemic. She also specialises in healthcare and pharmaceutical law which lets her provide tailor-made legal support in relation to production, export, import and trade of pharmaceuticals. Tsvetelina always stays up-to-date with the legal developments and recently assisted us on the implementation of new internal rules due to the COVID-19 pandemic, as well as in relation to setting up a laboratory for PCR and fast tests for COVID-19.’

Key clients

Acibadem City Clinic Tokuda Hospital

Acibadem City Clinic University Hospital

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

  • Defended Acibadem City Clinic Tokuda Hospital in a high-value case in two court instances against the National Health Insurance Fund (NHIF) concerning payments for medical care provided to health-insured patients above the limits set by the NHIF.
  • Advising Recordati (an international pharmaceutical group) on the establishment of a trade representation office in Bulgaria and on its overall activity in the Bulgarian market, including distribution of pharmaceuticals and donation of medical products.
  • Advised On Clinic on the purchase of 50% of the capital of Мedical Center-On Clinic Bulgaria, and on national regulations in response to the COVID-19 pandemic.

Kambourov & Partners

Kambourov & Partners is increasing its presence in the healthcare and life sciences sector, as is evidenced by its growing following among start-ups and innovative healthcare provider outlets. A multidisciplinary team advises on a broad suite of issues, ranging from regulatory and corporate matters to employment, data protection and patient confidentiality, IP and competition. Employment and immigration head Andrey Alexandrov and Ivo Alexandrov, who leads the firm's regulatory and compliance practice, steer the group.

Practice head(s):

Ivo Alexandrov; Andrey Alexandrov

Other key lawyers:

Yana Todorova; Mario Arabistanov

Key clients

Syneos Health

Biovet

Kartos Pharmaceuticals

Vertex Pharmaceuticals

Selena Cells

PartnerRe

DexCom

Specialized Hospital for Active Treatment in Obstetrics and Gynecology Selena

Shire Pharmaceuticals

Herbalife

Work highlights

  • Advised Syneos Health on corporate and regulatory matters.
  • Advised Kartos Therapeutics on corporate and regulatory matters.
  • Advised Vertex Pharmaceuticals on regulatory matters.

Murgova & Partners Attorneys at Law

Murgova & Partners Attorneys at Law offers a unique medical law focus, advising professional bodies, hospitals, clinics and other healthcare providers on their day-to-day activities and strategic planning, including clinical trials, public procurement for medical products and equipment and medical malpractice. Recent work includes advising a client on a patient support programme in a first-of-a-kind for Bulgaria. Name partner Petya Murgova has built a 15-year bank of experience in this sector, and co-leads the team with senior associate Alexander Stoimenov.

Practice head(s):

Petya Murgova; Alexander Stoimenov

Testimonials

‘The team at Murgova & Partners is staffed with motivated and competent lawyers, eager to help any client in the best possible way. The team researches in deep detail any issue, goes to the root of the problem and provides rock-solid ground for taking informed case-solving decisions. The competency of the team in covering a wide range of topics stands out, with leading members for each direction (healthcare, GDPR, IP rights, tax, etc.). For each case type there is leading expert in-house – this provides Murgova & Partners with top-edge expertise and very solid back-up for each case they defend in the court.’

‘Individual staff members in Murgova are encouraged to develop and specialise in specific sectors and this way become a valuable internal resource for the law firm. The client is met by competent and well-acquainted people and as result, the issue is analysed quickly and down to the very detail.’

Nice to talk to these lawyers. They are motivated and have deep knowledge.’

‘We have been in cooperation with Murgova & Partners since the establishment of our company in 2017. From then on, we have assigned the firm with all our cases which require legal expertise, without any exception. This refers either to our day-to-day activity related to drafting or supervision of complex commercial contracts, conducting negotiations with business partners or third parties, labour cases, etc., or to specific projects with significant impact over our company (including compliance projects, restructuring, etc.). Regardless of the assignment in question, the Murgova & Partners team has constantly been proving that they are equally capable of covering all our specific needs. ’

‘I would single out the managing partner Petya Murgova as a highly professional lawyer. She is extremely responsible and has an extensive experience in legal practice in healthcare. We can trust Petya in our daily business activity as a hospital. She manages to support us with appropriate legal advice in order to be fully compliant. During our cooperation Ms. Murgova has been constantly demonstrating her leadership and professional skills which we highly appreciate. Besides the managing partner, we would like to recommend Simeon Krastev, who proved to be a highly-effective, confident and well-prepared professional.’

Key clients

Specialized Hospital for Rehabilitation

SAT Health

Vitania VR

Digital Health and innovations Cluster Bulgaria

Penkov, Markov & Partners

Penkov, Markov & Partners provides regulatory, licensing, contractual, corporate and restructuring advice to domestic and international pharmaceuticals, healthcare companies and medical device manufacturers and wholesalers. Roman Stoyanov has more than 17 years' experience in the healthcare and life sciences sector, including representing various market authorisation holders (MAHs) before government authorities and the courts. Other names to note include associates Ivo Nickolchev, recruited from a clinical research organisation (CRO), and Ana Krusteva. Everty Group and Bless Medical are client gains.

Practice head(s):

Roman Stoyanov

Other key lawyers:

Ivo Nickolchev; Ana Krusteva

Key clients

Pierre Fabre Dermo-Cosmetics Bulgaria

InnoPharma/InnoPharma International BG

Berlin-Chemie AG/Berlin-Chemie/A.Menarini Bulgaria (part of Menarini Group)

Everty Bulgaria/Everty Group

NaturProdukt, affiliate of Dr. Theiss Naturwaren

Bless Medical

Zlatna Panega Cement (part of Titan Group)

Medical Center Mona Lisa

Work highlights

  • Advised Pierre Fabre Dermo-Cosmetics Bulgaria on the reimbursement of medicinal products by the National Health Insurance Fund (NHIF), and on marketing and promotional activities with respect to healthcare products.
  • Acted for Berlin-Chemie AG and Berlin-Chemie/A.Menarini Bulgaria in respect of contracts with healthcare professionals and the transfer of copyright and related intellectual property rights in favour of the assignor, among other issues.
  • Advised Naturprodukt, affiliate of Dr. Theiss Naturwaren, on contractual and other issues with a manufacturer of a medicinal product from the UK, whose Marketing Authorization Holder (and also owner of the brand) for Bulgaria is Naturprodukt, in view of Brexit.

Schoenherr (in cooperation with Stoyanov & Tsekova)

The cross-practice food and life sciences team at Schoenherr (in cooperation with Stoyanov & Tsekova) is led by attorney Elena Todorova, an emerging name in the food law space. Her practice also encompasses advice to pharma businesses, producers of medical devices and cosmetics, and marketers of chemicals and related products, among others. The firm ranks some leading names in the pharma and food sectors among its clients with a current highlight concerning the implementation of a pilot programme in Bulgaria.

Practice head(s):

Elena Todorova

Testimonials

‘I have worked with the colleagues from Schönherr for about six years now. The cooperation (legal exchange) is very efficient and pleasant. Elena Todorova was my main contact.’

Key clients

Dimitar Madjarov

OMV

Pharma Vision Europe

Amway

Taisho Pharmaceutical Co.

Work highlights

  • Advised Taisho Pharmaceutical Co. on the acquisition of the consumer health business UPSA of Bristol-Myers Squibb.
  • Advising Dimitar Madzharov, one of the largest food producers in Bulgaria specialising in dairy and meat products, 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.

Stoeva, Tchompalov & Znepolski

Stoeva, Tchompalov & Znepolski advises a broad array of healthcare industry participants, from a global pharmaceutical - GlaxoSmithKline - to individual healthcare professionals. Name partner Irina Stoeva has two decades' experience and a genuine focus in this area, and is 'an outstanding lawyer with impressive knowledge and experience in healthcare and commercial litigation.' Strengths of the practice include regulatory advice, litigation and public procurement, but the service offering encompasses all corporate and commercial needs. Of counsel Vania Todorova is a key member of the team.

Practice head(s):

Irina Stoeva

Other key lawyers:

Vania Todorova

Testimonials

‘Correctness, confidentiality, trust.’

‘Great practical experience.’

‘I work mainly with Irina Stoeva, who stands out with her calm, professional approach. Irina not only provides answers to concrete questions, but she looks for a soluion for the customer which is tailor made. ’

‘STZ represents a unique combination of partners with long-standing practices and young highly-motivated lawyers. They have displayed a great deal of creativity in our problems, solving specific regulatory problems related to my practice as a dentist and also concerning the Bulgarian Periodontics and Oral Implantology Society. We assess the overall level of service as excellent. The main factors which we consider are: swift and practicable advice; ability to work against challenging deadlines; flexibility and strength-in-depth of team. We have used some other law firms and individual lawyers over the years for different issues. However, after we started working with Irina and her team, we found out that they cover all law areas that may concern our activity.’

‘For me, 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 to reach the optimal outcome in several commercial cases. Other STZ team members to praise are Vania Todorova and Miroslava Iordanova, both very knowledgeable, dedicated and precise lawyers. ’

Key clients

GlaxoSmithKline

Perrigo )

Adriatic BST

Sofia Regional Pharmaceutical Association

Ekan – Lubomir Subev

Adriatic

Sofia Business Consulting Group

Dr. Adriana Iossifova – Periodontics and Oral Implantology Society

Dr. Mark Danan (France)

Work highlights

  • Advised GlaxoSmithKline (Bulgaria) on public procurement procedures for deliveries of medicines (HIV products and vaccines) during the state of emergency in Bulgaria resulting from the COVID-19 pandemic.
  • Advised Perrigo on a change of commercial model.
  • Represented a renowned French dentist before the Bulgarian Ministry of Health in a procedure under the EU Professional Qualifications Directive 2005/36.

Wolf Theiss

Wolf Theiss advises a substantial client base of R&D and generic pharma, medical device and clinical trial companies as well as banks and investors. It is particularly strong in providing coporate advice to multinationals, and is regularly the firm of choice for large-scale regional deals in the sector. Regulatory work includes acting for clinical trials company Celgene International regarding its business in Macedonia and Bulgaria. Managing partner Anna Rizova steers a versatile team including recently-promoted counsel Hristina Dzhevekova.

Practice head(s):

Anna Rizova

Other key lawyers:

Hristina Dzhevlekova

Key clients

Rabobank

Pappy Pharma

Celgene International

STS Medical Group

Reckitt Benckiser

Boehringer

Work highlights

  • Advising Rabobank with respect to securitization of trade receivables originated by Bulgarian sellers forming part of Huvepharma Group, owning from various obligors, including Bulgarian companies.
  • Advising an Albanian pharmaceutical company entering the Bulgarian market on its strategy for establishing its business presence in the country.
  • On-going advice to Celgene Management, a global biopharmaceutical company, on compliance and regulatory matters in North Macedonia and Bulgaria.