Healthcare and life sciences in Bulgaria

Boyanov & Co.

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.

Practice head(s):

Kina Chuturkova; Peter Petrov

Key clients

Sanofi Group companies

Neola Pharma EOOD

Actelion Pharmaceuticals Ltd.

Hoffmann La Roche

Alcon

AbbVie

Shire

ARPharM Bulgaria

Bayer

Novartis

Mylan

GSK

Pharmaceutical Research Associates

inVentiv Health Bulgaria

CST Pharma

Celgene Corporation

Merck

Medtronic

Work highlights

  • Acted for Sanofi Pasteur – France and Sanofi Aventis – Hungary in a €3.8m damages case.
  • Advised the Association of Research-based Pharmaceutical Manufacturers in Bulgaria (ARPharM) on the proposed new regulatory framework concerning priority prescriptions for biosimilar pharmaceutical products.
  • Advising Actelion on contractual and regulatory issues related to carrying out clinical trials in Bulgaria.

CMS

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.

Practice head(s):

Angelika Sedlackova

Key clients

Johnson & Johnson

Amgen

Egis

Takeda

Eli Lilly

Medtronic

Merck

Valeant

Bristol-Myers Squibb

Advent International

Work highlights

  • Assisted with Advent International’s €1.9bn acquisition of Zentiva, Sanofi’s generics business.
  • Providing ongoing advice on corporate and regulatory compliance matters to Johnson & Johnson in Bulgaria.

Dimitrov, Petrov & Co

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.

Practice head(s):

Bilyana Angelova

Testimonials

‘They have achieved success in a number of proceedings with potentially serious financial and reputational effects for our business.’

‘Encho Simeonov has no rival in Bulgaria in the field of medical malpractice law. He has always impressed me with the unique combination of legal knowledge and understanding of the specifics of the medical treatment.’

‘Despite the complexity of the proceedings they handle for us, I have never seen them discouraged and without a solution.’

Key clients

Pfizer Luxemburg SARL, Bulgaria Branch

Johnson & Johnson Bulgaria

Eli Lilly/SUISSE/SA

Boehringer Ingelheim RCV GmbH & Co KG – Bulgarian Branch

Optimapharm EOOD

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

Zonapharm OOD and Zona Pharma OOD

Ergomed

PMA – Pharma Marketing

Advisors

Genetic medico-diagnostic laboratory Genica

Work highlights

  • Advising Pfizer on a range of matters on an ongoing basis, including seconding an associate to the client.
  • Acted successfuly for the Specialised Pediatric Hospital for Active Treatment in medical malpractice proceedings.
  • Assisting ZonaPharma with its launch of new food supplements on the Bulgarian market.

Djingov, Gouginski, Kyutchukov & Velichkov

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.

Practice head(s):

Kalina Tchakarova

Key clients

Abbott Laboratories Europe

Abbott Laboratories S.A. (TRO)

AbbVie EOOD

AbbVie Inc.

ACIBADEM CITY CLINIC EAD (former TOKUSHUKAI SOFIA EOOD)

Actavis EAD

Akros Pharma Inc.

Alcon Bulgaria EOOD

ALVOGEN EMERGING MARKETS HOLDINGS LIMITED

Amway

Amylum Bulgaria

Artevos GmbH

Aspen Pharma Ireland Limited (former Aspen Europe GmbH)

Aspen Pharmacare Holdings Limited

ASTELLAS PHARMA EOOD

Astellas Pharma Europe Ltd.

Baxalta Incorporated

Baxter International Inc.

Beiersdorf AG

Bella Bulgaria AD

Berlin-Chemie AG

BIO FRESH OOD

Bunge Romania S.R.L

Bunge ZRt

Cardinal Health

Cargill Bulgaria EOOD

Centogene AG

Ceridian HCM, Inc.

ClinTec International Ltd.

Coca-Cola Enterprises

Covance

Covance Clinical and Periapproval Services Limited

Deroni OOD

Domain Menada Distribution ЕООD ( former BELVEDERE DISTRIBUTION EOOD)

Dow Deutschland Inc.

EU Pharmacia Bulgaria

Fabrika za mlechni produkti AD

Farmak JSC

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

Froneri Bulgaria EOOD

General Electric Healthcare

Gradus – 1 OOD

GrowGreen Europe

Insmed

Ital Food Industry

Ionis Pharmaceuticals

J.S. Hamilton Poland S.A.

Kaliakra AD

Laboratoires Théa

Laboratory Corporation of America Holdings (LabCorp)

Les Laboratoires Servier

Malteries Soufflet Bulgaria

Marie Brizard Wine & Spirits SA ( former Belvedere S.A.)

Medical Centre Synexus Sofia

Medilab

Menada Vineyards

Merck Bulgaria

Merit Medical, Regeneron

METRO Cash & Carry Bulgaria

Monsanto International – Bulgaria Branch

MSD Animal Health

Mundipharma GmbH

Mylan

Nuseed Europe Ltd.

Pet Centar D.O.O.

Pharmascience

Pharmastore Invest OOD

Premier Research Germany Limited Representative office

Provitech Solutions ЕООD (former Provident Funding)

Red Bull GmbH

Regeneron

Risoil BV

Risoil Overseas Ltd.

S.C. Star Foods E.M. S.R.L.

Sakar Vineyards EOOD

Samsung Bioepis

Schreiber Foods Bulgaria

SEEDS OIL GRAIN Ltd

Shire Central & Eastern Europe GmbH

Shire plc

Soufflet Groupe

The Body Shop International Plc

VisLab S.r.l.

Z-Labs EOOD

ZOLL Circulation

Work highlights

  • Advising Mylan on an ongoing basis regarding the regulatory framework concerning pharmaceuticals in Bulgaria.
  • Assists Astellas Pharma Europe with claiming reimbursement for medicines and medical devices through the National Health Insurance Fund.
  • Acted for EU Pharmacia Bulgaria in a dispute with the Bulgarian subsidiary of Walmark concerning alleged unfair competition.

Tsvetkova Bebov Komarevski

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.

Practice head(s):

Ilya Komarevski

Testimonials

‘They always act fast and provide timely response even within critically short deadlines.’

‘They are very experienced professionals with strong industry-specific backgrounds, which helps them give straight-to-the point, solution-oriented, and practical advice.’

Key clients

AstraZeneca

Takeda

AmGen

Promedica24 Care

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

Polpharma (Zakłady Farmaceutyczne Polpharma S.A.)

Berlin Chemie

LIDL

Mars

Wrigley

Royal Canine

Work highlights

  • Providing ongoing advice, including on reimbursement, clinical trials, and competition matters, for AstraZeneca.
  • Acting for Takeda in contentious and non-contentious matters.
  • Advising Polpharma on pharmaceutical marketing regulation.

Wolf Theiss

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.

Practice head(s):

Anna Rizova

Testimonials

‘The team is well-organised, coordinated, efficient and highly capable. They perform legal research quickly and deliver advice to short deadlines.’

 ‘The team members are highly professional, in terms of knowledge, attitude, and self-confidence. We always rely on their clear and comprehensive advice.’

Key clients

BASF

IMS Health Technology (IQVIA)

STS Medical Group

Reckitt Benckiser

Pierre Fabre

Boehringer

Celgene

Align

Arysta LifeSciences

Vertex Pharmaceuticals Incorporated

Work highlights

  • Advising KKR & Co on enlarging its portfolio of managed companies to include a company specialising in pathologist’s instruments.
  • Assisting with the possible data protection implications of a mobile application used in clinical trials to monitor trial patients’ adherence to their prescribed medication.
  • Advising Pappy Pharma, an Albanian pharmaceutical company, on entering the Bulgarian market.

Deloitte Legal Law Firm

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.

Practice head(s):

Reneta Petkova; Miglena Micheva

Georgiev, Todorov & Co

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.

Practice head(s):

Ivan Todorov

Testimonials

‘The lawyers have fast reactions, a great reputation in the sector, and are extremely professional.’

‘We highly value the competence of the team, and their availability to meet our demands and needs in order to give us exceptional legal advice.’

Key clients

Medical Centre Hill Clinic

Medical Centre On Clinic

Roche Bulgaria

Lyulin Hospital

Acibadem City Clinic

Tokuda Hospital

Acibadem City Clinic Cardiac Surgery Hospital Burgas

Acibadem City Clinic University Hospital

MBAL Evropa

MBAL City Clinic “Sveti Georgi” Hospital Montana

MBAL Uni Hospital Panaguirishte

SGP Bio Dynamics Ltd.

Naturprodukt Bulgaria

Work highlights

  • Represented City Clinic Cardiac Surgery Hospital Burgas in proceedings against the National Health Insurance Fund.
  • Advising Hill Clinic on negotiations for its intended sale to On Clinic.
  • Acted for MBAL Uni Hospital Panaguirshte in a dispute with the National Health Insurance Fund (NHIF) for unpaid medical activity by the NHIF.

Murgova & Partners Attorneys at Law

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 effectiveSimeon Krastev is another key contact.

Practice head(s):

Petya Murgova; Alexander Stoimenov

Penkov, Markov & Partners

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.

Practice head(s):

Vladimir Penkov; Roman Stoyanov

Testimonials

‘Roman Stoyanov has been collaborating with our company for almost 10 years and has supported us with his professionalism and precision in matters of development and clinical research.’

Key clients

Pierre Fabre Dermo-Cosmetics Bulgaria EOOD, part of the Group Pierre Fabre

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

Berlin-Chemie AG and Berlin-Chemie/A.Menarini Bulgaria EOOD part of Menarini Group

Medical Center Mona Lisa EOOD

Work highlights

  • Advising on the structure of clinical trials for InnoPharma International BG.
  • Acted for Berlin-Chemie on the use of software-as-a-service products in order to verify supply chains and avoid falsified and counterfeit chemical products.
  • Advising Medical Centre Mona Lisa on carrying out clinical trials for a medical device manufacturer.

Schoenherr (in cooperation with Stoyanov & Tsekova)

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.

Practice head(s):

Elena Todorova

Testimonials

‘Elena Todorova is very proactive.’

Key clients

Amway

OMV

Pharma Vision Europe Ltd

Take Away

AddLife AB

Work highlights

  • Advised Pharma Vision Europe on its registration in Bulgaria and the establishment of its distribution chains.
  • Acting for OMV on consumer protection laws pertaining to food safety.
  • Assisting Amway with food safety and labelling requirements for its line of nutritional supplements.

Stoeva, Tchompalov & Znepolski

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.

Practice head(s):

Irina Stoeva

Key clients

GlaxoSmithKline (Bulgaria, UK)

Perrigo (Belgium, Bulgaria)

Adriatic BST (Slovenia)

Sofia Regional Pharmaceutical Association

Ekan – Lubomir Subev (Bulgaria)

Adriatic D.O.O (Serbia)

Sofia Business Consulting Group (Bulgaria)

Work highlights

  • Working alongside Baker McKenzie to advise on the merger of the consumer healthcare businesses of GlaxoSmithKline and Pfizer.
  • Reviewed sale and distribution contracts for Perrigo.