Healthcare and life sciences in Bulgaria

Boyanov & Co.

Boyanov & Co. has a strong foothold in the pharmaceuticals industry, where they advise international pharmaceutical and generics companies, namely AstraZeneca, AbbVie and Pfizer Bulgaria, on IP and trade mark rights, patent protection and litigation, price regulation and medical reimbursements, while also being well versed in related competition and antitrust matters. Kina Chuturkova and Peter Petrov jointly lead the practice, with the former specialising in litigation and arbitrations, and the latter handling regulatory advice and pharmaceutical antitrust. Nedyalka Novakova supports the team on a range of issues including day-to-day advice to pharma companies and contractual support for clinical trials.

Praxisleiter:

Kina Chuturkova; Peter Petrov


Weitere Kernanwälte:

Nedyalka Novakova


Referenzen

‘Excellent team that understands business needs.’

‘Peter Petrov is renowned for his expertise in healthcare and life sciences – right to the point and no waste of time.’

‘Boyanov & Co clearly stands out of the other law offices in Bulgaria. Professionalism, industry knowledge and high responsiveness make Boyanov & Co an irreplaceable advisor in the country.’

Kernmandanten

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


Highlight-Mandate


  • Represented AbbVie in a litigation against the secondary legislation instituting the Bulgarian pharmaceutical claw-back system, responsible for collecting more than EUR 100m in payments from the pharmaceutical industry.
  • Advised ARPharM on reform proposals for the primary and secondary regulation of the Bulgarian reimbursement system, to ensure a fairer risk allocation between the public health insurance scheme (NHIF) and the pharmaceutical industry.

Dimitrov, Petrov & Co

International pharmaceutical companies and their Bulgarian subsidiaries rely on Dimitrov, Petrov & Co for day-to-day support on issues of price regulation and reimbursements of medicinal products, contracts with wholesalers and service providers, clinical trials as well as IP, consumer protection and advertising compliance matters. The group is also frequently handles contentious mandates, including patent litigation, employment disputes and medical malpractice cases. Zoya Todorova, who is praised for her ‘in-depth industry knowledge’, provides regulatory advice to pharma companies and leads the practice alongside Martin Zahariev, whose expertise lies in intellectual property, life sciences and data protection. Yana Georgieva is a key part of the team and provides ongoing support to pharmaceutical companies as well as handling various trade mark matters.

Praxisleiter:

Zoya Todorova; Martin Zahariev


Weitere Kernanwälte:

Encho Simeonov; Yana Georgieva; Radina Tomanova; Rositsa Vasileva; Konstantin Kostadinov


Referenzen

‘The team provides timely and working solutions. As an end customer, this is what makes the difference.’

‘I work with Yana Georgieva. She is collaborative, responsive, trustworthy, engaged and provides timely and working solutions.’

‘I had an excellent experience working with DPC on a variety of healthcare and life Sciences cases in BG. Their team is composed of highly skilled and competent individuals, with great experience and business acumen, providing thorough and pragmatic counsel.’

Kernmandanten

Pfizer Luxemburg SARL, Bulgaria Branch


Johnson & Johnson Bulgaria EOOD: Janssen-Cilag International


Eli Lilly/SUISSE/SA


Medison Pharma Trading


Zaklady Farmaceutyczne POLPHARMA S.A


Pharmalake Bulgaria EOOD


Hell Energy


Ergomed


PMA – Pharma Marketing|Advisors


Highlight-Mandate


  • Provides complex and daily legal support to Pfizer Luxemburg SARL, Bulgaria Branch.
  • Provides regular legal advice on a variety of matters to Janssen-Cilag.
  • Provides regular legal advice on a variety of matters to Eli Lilly/SUISSE/SA.

Djingov, Gouginski, Kyutchukov & Velichkov

Djingov, Gouginski, Kyutchukov & Velichkov’s pharma and healthcare practice offers a broad advisory service, comprising IP, regulatory, competition and antitrust support on clinical trials, market entries of generic medicines and litigation proceedings. The team advises life sciences companies, manufacturers, retailers, hospitals and pharmaceutical companies and is led by Kalina Tchakarova, an expert on medicinal product regulation, reimbursement and pricing, compliance and advertising. Vlada Tsenova and Desislava Iordanova are key practitioners in this field and are praised for their ‘expertise in complex and demanding projects’.

Praxisleiter:

Kalina Tchakarova


Weitere Kernanwälte:

Vlada Tsenova; Dessislava Yordanova


Referenzen

‘Litigation knowledge.’

‘The team led by partner Kalina Tchakarova is a fine blend of experienced regulatory, litigation and IP lawyers, who collaborate very well together on all client matters involving inter-disciplinary approach. Moreover, they have very good understanding and knowledge about the specific challenges faced by the industry, which enables them to give focused and practical advice.’

‘I have had the pleasure to work with Kalina Tchakarova, Vlada Tsenova and Dessislava Yordanova and our collaboration in numerous matters has been great. They are practical and possess hands-on expertise in complex and demanding projects, which shines through their advice.’

Kernmandanten

Abopharma Bulgaria & Technocom Trade


Accord Healthcare


Baiersdorf Bulgaria


Biogen Netherlands BV


GE Healthcare


Gedeon Richter


Genmab A/S


Novo Nordisk


Swedish Orphan Biovitrum AB (Sobi)


Uniqa Dental Ltd.


Viatris (Mylan Ireland Limited and Mylan EOOD)


Highlight-Mandate


  • Advises Biogen Netherlands BV in a complex case related to one of their leading medicinal products with expiring patent protection but still protected against placement on the market of generic analogues.
  • Advises Gedeon Richter PLC on regulatory and IP matters related to placement of generic medicinal products in Bulgaria and representation in several pending patent infringement cases and patent invalidation procedures.
  • Assistance of Swedish Orphan Biovitrum AB (Sobi) on all aspects of its operations in Bulgaria, including compliance, patient programmes, distribution matters, tax, HCP agreements, advertising and other promotional campaigns, data protection.

CMS

CMS’ client portfolio includes international pharma and biotech companies, who turn to the team for advice on commercial matters and documentation, such as distribution, agency and wholesale agreements, as well as a whole host of regulatory questions related to clinical trials, medicinal, cosmetic and consumer products. The practice is led by three practitioners: Anna Tanova, who handles regulatory, data protection and IP matters, Assen Georgiev and Antonia Kehayova, who are both well versed in life sciences and healthcare litigation.

Praxisleiter:

Anna Tanova; Assen Georgiev; Antonia Kehayova


Referenzen

‘The team in CMS that I have worked with has been attentive and engaged in the matters of business.’

‘I have worked more closely with Anna Tanova regarding trials agreements. She was responsive and engaged and provided a timely and working solution. As an end customer this is what matters to me.’

Kernmandanten

Carl Zeiss GmbH


Highlight-Mandate


Deloitte Legal Law Firm

Deloitte Legal Law Firm routinely advises Bulgarian medical devices companies, drug wholesalers and pharmaceutical companies on issues pertaining to the digitalisation of their businesses, regulations on the launch of new products and data protection in clinical trials, while also providing ongoing employment, corporate and marketing legal advice. Miglena Micheva heads the team and provides clients with pharma regulatory and compliance advice.

Praxisleiter:

Miglena Micheva


Weitere Kernanwälte:

Irena Koleva; Kristian Nemtsov


Referenzen

‘Extremely hard-working and conscientious. Quick and competent feedback. Very deadline oriented by providing timely and professional advice.’

‘The team of motivated professionals (Irena Koleva and Miglena Micheva) makes a unique impression, with a quick understanding of the client’s needs.’

Highlight-Mandate


Eversheds Sutherland

Eversheds Sutherland’s pharma, food and life sciences team is well versed in matters of market access, pricing and reimbursement, clinical trials and advertising, where the team supports manufacturers of pharmaceuticals, medical devices, food and pet food on an ongoing basis. Eleonora Mateina, who handles a range of regulatory and competition issues for the firm’s pharma and life sciences client roster, leads the team alongside managing partner Irina Tsvetkova. Philip Kiossev is another key name in the department and often represents healthcare clients court proceedings.

Praxisleiter:

Irina Tsvetkova; Eleonora Mateina


Weitere Kernanwälte:

Philip Kiossev


Referenzen

‘Knowledge and commitment.’

Kernmandanten

AstraZeneca


Royal Canin


Podravka


Colgate-Palmolive


Highlight-Mandate


  • Advise AstraZeneca in Bulgaria on an ongoing basis, including on regulatory matters, pricing and reimbursement (including court appeals), application of code of ethics and others.
  • Advise a marketing authorisation holder of medicinal products in two court proceedings regarding pricing of medicinal products.
  • Advise Colgate-Palmolive on a range of regulatory matters, such as data protection and privacy, product packaging and labeling, corporate and contractual matters, as well as employment.

Georgiev, Todorov & Co

Georgiev, Todorov & Co’s ‘team of highly experienced lawyers’ are highly regarded for their experience advising Bulgarian hospitals in disputes against the National Health Insurance Fund regarding payment liability for medical care and services. On top of this, the practice advises a number of pharmaceutical and healthcare companies on regulations, supply agreements and IP matters on an ongoing basis. Practice head Ivan Todorov has extensive experience in healthcare-related disputes before administrative and regulatory bodies.

Praxisleiter:

Ivan Todorov


Weitere Kernanwälte:

Tsvetelina Dimitrova; Dobrina Pavlova; Tsvetelina Mileva; Arno Mamasyan


Referenzen

‘Georgiev, Todorov & Co is a highly distinguished and reputable law firm in Bulgaria, having a wide range of fields of expertise in which they can be useful, especially in the field of healthcare. Their big advantage is their exceptional expertise as well as the individual approach to each client’s needs, and are very quick in finding the proper solution to any given legal matter.’

‘The legal team of Georgiev, Todorov & Co, we predominantly work with, stands out with its exceptional professionalism, creative ideas and approach in handling complicated legal disputes, as well as finding fast and accurate solutions. We are extremely impressed by the work ethics and competency of .Ivan Todorov, Arno Mamasjan, Dobrina Pavlova and Tsvetelina Mileva.’

‘The law firm is our preferred legal advisor for many years because of its excellency in providing legal services tailored to our specific needs and because of their team of well prepared and experienced professionals in different fields, which in my opinion is the strength of the firm. I believe this is one of the strongest law firms on the market, especially good in healthcare matters.’

Kernmandanten

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.


Highlight-Mandate


  • Successfully defended Acibadem City Clinic University Hospital in a dispute with the Bulgarian National Health Insurance Fund (NHIF).
  • Represented Multi-profile hospital for active treatment (MHAT) City Clinic ‘St. Georgi’ Montana against the Bulgarian National Health Insurance Fund (NHIF) on two claims for unpaid medical activities and medical products.
  • Advised multi-profile hospital for active treatment (MHAT) Uni Hospital to protect its interests against the Bulgarian National Health Insurance Fund (NHIF) on а claim for unpaid medical activities and medical products.

Kambourov & Partners

Kambourov & Partners broad healthcare practice supports healthcare providers, pharma companies and consumer goods manufacturers, including health supplements, in a broad range of day-to-day matters. Recent work has included due diligence on clinical trials, patent registration of products, medical distribution advice as well counsel on regulatory, employment and consumer protection questions. Ivo Alexandrov, who specialises on regulatory and compliance mandates in the healthcare sector, and Andrey Alexandrov, who is an expert employment, data protection and white collar crime, jointly lead the team.

Praxisleiter:

Ivo Alexandrov; Andrey Alexandrov


Weitere Kernanwälte:

Zlatko Grigorov


Referenzen

‘The individuals I have worked with have shown a great care for my inquiries and passionate approach to resolving them.’

Kernmandanten

AbbVie Inc.


Dentstore Bulgaria


Sarepta Therapeutics


Herbalife


NN Life Insurance


Samex LLC


Intermedica


Arlington Capital Partners


AFT Pharmaceuticals


Medical Centre for Specialised Medical Care for Cardiovascular Diseases


Center for European Health Policies


Dineras


Highlight-Mandate


  • Advised AbbVie Inc. regarding the applicable regime for reimbursement of medicines by the Bulgarian National Health Insurance Fund (NHIF) as well as the rules on clawbacks (industry contributions) for such reimbursed medicines.
  • Advises the Medical Centre for Specialised Medical Care for Cardiovascular Diseases on a complex corporate restructuring and investment transaction.
  • Advises Sarepta Therapeutics on various regulatory matters in Bulgaria.

Penkov, Markov & Partners

Penkov, Markov & Partners' healthcare and pharmaceuticals practice encompasses regulatory, IP, marketing compliance as well as litigation support, related to pharmaceutical and healthcare products, medical devices, food supplements and clinical trials. Roman Stoyanov leads the team, and his experience includes giving advice on the authorisation, licensing and pricing of medicinal products as well as healthcare related disputes.

Praxisleiter:

Roman Stoyanov


Weitere Kernanwälte:

Ana Krusteva; Tihomir Tishev


Referenzen

‘Excellent knowledge in the industry, always well within reach and very client-orientated approach.’

‘The strengths of the team is their responsiveness, understanding of the case matter and readiness to resolve any issue and think proactively about the potential solutions. What İ like about working with the law firm is their mentality and people oriented approach. They act like your friends.’

‘Roman Stoyanov – a great professional, outstanding character, always ready to help. Outstanding!’

Kernmandanten

Pierre Fabre Bulgaria EOOD, part of Pierre Fabre Group


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


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


Fresenius Medical Care Bulgaria EOOD


SMTL Puldin Ltd.


NaturProdukt OOD, affiliate of Dr. Theiss Naturwaren GmbH


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, exclusive representative for Bulgaria of Dr. Ihde Dental AG (Switzerland)


Skin Systems Hospital


Highlight-Mandate


  • Advise Skin Systems on various regulatory and compliance regimes.
  • Assisted Naturprodukt OOD for the launch of a new major advertising campaign regarding different types of products (TV, social media and on spot ads in pharmacies and drugstores), encompassing overall analyses of the various acts and guidelines of the local authorities on the good advertising practices, restrictions and exceptions.
  • Advised Pierre Fabre Bulgaria in a dispute with a local wholesaler, claiming abuse of dominance position on the market of our client, being Marketing Authorisation Holder of innovative medicinal product in a specific oncology decease treatment field.

Schoenherr

A standout feature of Schoenherr’s healthcare and life sciences practice is its expertise in relation to food and consumer non-food goods legal matters, where the team handles a litany of regulatory, compliance and consumer protection mandates, led by Elena Todorova, who has ‘profound knowledge’ in this field. Next to food business operators and manufacturers, the team also regularly advises healthcare, pharma and R&D companies.

Praxisleiter:

Elena Todorova


Weitere Kernanwälte:

Alexandra Minioti; Marin Demirev; Gergana Roussinova-Ivanova


Referenzen

‘The practice is really business oriented, well understands and knows the legal background, authority practice and it is able to provide a business and practical solution and not just theoretical advice.’

‘People we have worked with are very responsive, understand the pressing matter of time for the business and are able to provide high quality service within limited amount of time.’

‘They provide perfect assistance and know-how and they are very professional. This practice has reputation for excellence and professionalism. I see Elena Todorova as a one of the key experts in this field in the country.’

Kernmandanten

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


Highlight-Mandate


  • Advising 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 regulatory aspects of its local business regarding consumer protection as well as on the regulatory and IP aspects of cosmetic product labelling and advertising of non-food issues.
  • Advising Capital One Bank on the Bulgarian aspects of a $31m senior debt financing for Healthcare Components Group’s acquisition of American Optics – Endoscope Replacement Parts and Replacement Parts Industries.

Stoeva, Tchompalov & Znepolski

Stoeva, Tchompalov & Znepolski, praised for ‘excellent expertise in the healthcare sector’, advises pharmaceutical and healthcare clients, namely GSK and Haleon, on regulatory compliance, adherence to new legislation and public procurement procedures. Irina Stoeva leads the practice and works on an ongoing basis with the firms leading healthcare and pharmaceutical companies.

Praxisleiter:

Irina Stoeva


Referenzen

‘The practice has excellent expertise in the healthcare sector. They always provide high quality advice and the best solutions for our company.’

‘Irina Stoeva is very flexible and reacts quickly on requests. She always tries to propose alternative solutions if it is necessary. Is attentive to internal processes of a client as well as provides clarifications regarding external regulations and trends.’

‘The team has high level of knowledge of health legislation.’

Kernmandanten

GlaxoSmithKline (GSK)


Perrigo


Haleon


EU Pharmacia Bulgaria, member of USP Group


Ekan – Lubomir Subev (Bulgaria)


Periodontics and Oral Implantology Society (Bulgaria)


Medic X (Bulgaria)


SottoPelle Bulgaria


Unilab Plc, USA


Highlight-Mandate


  • Advises Haleon on local regulatory requirements.
  • Advised GlaxoSmithKline (GSK) on variety of regulatory matters, implementation of AI in the HR management, and issues related to the public procurement of vaccines.
  • Act as legal adviser of the Bulgarian wholesaler Medik X Ltd.

Wolf Theiss

Wolf Theiss’ healthcare and life sciences practice provides clients with day-to-day advice, including on employment and data protection matters, as well as on transactions and litigation matters, where a range of pharma companies, clinical trials providers and medical devices manufacturers belong to the firm’s client base. Anna Rizova leads the team and handles compliance, licensing and data protection matters in this field. Hristina Dzhevlekova is another key name in the department.

Praxisleiter:

Anna Rizova


Weitere Kernanwälte:

Hristina Dzhevlekova; Zhulieta Markova


Kernmandanten

Edgecap Partners


Intuitive Surgical Operations


STS Medical Group


Highlight-Mandate


  • Advises and assists Intuitive Surgical on its investment into a production facility in Bulgaria.
  • Advises and represents STS Medical on Bulgarian law aspects.
  • Advised EdgeCap on the acquisition of COMAC Medical – a clinical trials provider in Bulgaria.