Life sciences and healthcare in Argentina

Baker McKenzie

Baker McKenzie offers multi-disciplinary advice to local and international life sciences clients, providing comprehensive coverage of regulatory, consumer safety, competition, IP, data protection, compliance and contractual matters. Clients turn to the team for support on licence requirements for product manufacturing, sales, distribution and advertising under local law, as well as advice related to the acquisition of product approvals, data exclusivity issues, pricing, delisting, adverse event reporting, and product liability and recall matters. Antitrust and competition law in the life sciences and medical devices industries is another focus area, with the firm also sought out for support on healthcare-related trademark enforcement and trademark and patent prosecution work. The team is also active in healthcare M&A, frequently representing multinational clients. Commercial and contractual matters and liability disputes (including product safety and regulatory non-compliance issues) are also handled. Practice head Vanina Caniza is a life sciences specialist and first port of call for multinational life sciences groups seeking support on corporate compliance, commercial agreements, M&A and regulatory advice. Caniza also serves as the global chair of the firm’s healthcare and life sciences industry group, and has developed deep technical knowledge after completing post-graduate studies in biotechnology. Senior associate Rocío Rojas Iglesias focuses on regulatory and commercial law matters, with the practice also able to draw on the experience of litigation and arbitration lawyer Santiago Maqueda when required.

Responsables de la pratique:

Vanina Caniza


Principaux clients

Abbvie Laboratories/Allergan


Abbott Laboratories


Amicus


Axenya


Bausch & Lomb


BeiGene


Biogen


Boston Scientific


Centessa


CSL Behring


Dentsply Sirona


Embecta


Gilead Sciences


GlaxoSmithKline/Haleon


ISDIN


ICU Medical


Johnson & Johnson


Karl Storz


Kenvue


Knight


Laboratorios Seqirus


LifeScan


Moderna


MSD Argentina (Merck)


Nu Skin


Ortho-Clinical Diagnostics


Procter & Gamble


Reggeneron


Stryker


Colgate


Principaux dossiers


  • Assisted Abbvie Laboratories in the merger of Allergan and Abbvie, including preparing a regulatory step plan to structure the transaction at local level and transition from the current business operation to a new scheme.
  • Continuing to assist Bausch & Lomb, the eye-care health company, on several compliance-related matters.
  • Advised Embecta on its reorganisation in Argentina following Beckton Dickinson’s decision to spin-off its global diabetes business and transfer assets to the local Embecta entity.

Marval O’Farrell Mairal

Marval O’Farrell Mairal‘s highly specialised, standalone life sciences practice is the first port of call for premier international and local clients, and leverages the firm’s full-service capabilities to provide comprehensive, multi-disciplinary advice that covers large, complex cross-border life sciences and healthcare transactions, antitrust issues, regulatory matters, product registrations, compliance, and patent prosecution and enforcement. The firm is frequently called on to assist multinational life sciences and healthcare businesses with setting up operations in Argentina, and will also lead and coordinate pan-regional deals in the sector. Practice head Martín Mosteirin is an industry reference and advises major life sciences clients on a wide range of regulatory, transactional and contentious matters. A talented bench of senior associates, including Camila Leone (who has a focus on M&A, healthcare claims, and restructurings) and Carolina Andrea Ramírez (who routinely advises on regulatory strategy and compliance) provide capable support.

Responsables de la pratique:

Martín Mosteirin


Les références

‘A professional team with deep expertise in the area. Responsive and available when required by clients.’

‘The team displays exceptional life sciences industry knowledge. A reference practice in Argentina.’

‘Martín Mosteirin is very responsive, knowledgeable and has a great relationship with clients and an extensive network of external counsels.’

Principaux dossiers


  • Advised Fresenius Medical Care, a kidney therapy business, on the sale of its business in Argentina to Well Being, a company belonging to Grupo Olmos, including 76 dialysis clinics, a manufacturing plant at Pilar and the medicines and medical devices products’ portfolio in the country.
  • Advised Takeda Pharmaceutical on the spin-off of its entire gastroenterology portfolio for the Latam and Caribbean region, including the transfer of trademarks and product marketing authorisations, to Adium Pharma.

Allende & Brea

Allende & Brea‘s fast-growing life sciences practice assists life sciences and healthcare clients with a comprehensive service that covers corporate, contractual, transactional, regulatory, IP, data protection, compliance, antitrust, labour, tax, customs, and foreign exchange matters. The firm has picked up an increasing volume of transactional work and is well versed in regulatory matters, including work involving the National Administration of Drugs, Food and Medical Technology (ANMAT) and the National and Provincial Ministries of Health. Other areas of expertise include clinical trials, the import, export and sales of medical products in Argentina, healthcare packaging and labelling, and compliance advice and training. The firm has also built up niche expertise in medicinal cannabis and hemp regulatory matters. The practice is co-led by administrative law and regulatory specialist María Morena Del Río and the highly rated Fernando Martínez Zuviría, who covers regulatory, licensing, transactional and distribution matters, as well as playing a leading role in advising on new medical cannabis and hemp regulations in Argentina. At associate level, seniors Vanesa Fernández (an expert in life sciences regulation) and Lucrecia Re (who focuses on administrative law and regulation) are the main points of contact.

Responsables de la pratique:

Fernando Martínez Zuviría; María Morena del Río


Les références

‘Fernando Martínez Zuviría has deep knowledge, not only of the law and market of Argentina, but also of our company and our needs.’

‘Allende & Brea is recognised for its exceptional performance in the area of ​​life sciences and healthcare, standing out for its professionalism and ability to adapt to the specific needs of its clients.’

‘What makes this legal practice unique is its proactive approach, willingness to be challenged and its constant search for improvements in the services and advice provided.’

Principaux clients

Aspen


Compass Group


CSL Behring


Ferrero


Fundación Oncológica Anna y Elena Bonatti Rocca


LSG Sky Chefs


Kellogg’s


Novartis


Reckitt


Siemens Healthcare


Thermo Fisher


Viatris


Principaux dossiers


  • Advised Novartis on regulatory matters related to a direct purchase tender called by the Argentine Ministry of Health for the purchase of Zolgensma, a prescription gene therapy used to treat children under two years old with spinal muscular atrophy.
  • Advising Fundación Oncológica Anna y Elena Bonatti Rocca on the day-to-day legal matters for a new, fully equipped cancer treatment centre in the province of Corrientes.
  • Advised Viatris, a company formed following a merger between Mylan and Pfizer’s off-brand pharmaceutical business, on the transfer of medicinal products and other assets from Pfizer to Aspen Labs, a third-party buyer in Argentina.

Beccar Varela

Beccar Varela‘s well-established life sciences practice provides pharmaceutical, medical devices, cosmetics, healthcare services and digital health companies with a full-service offering that includes coverage of commercial matters, IP, litigation, licensing and M&A in the industry. The firm is particularly well known for its deep regulatory expertise, and is called on for support with clinical trials, drug approvals, and issues related to post-trial access to study drugs. Other active areas include work involving orphan drugs, Argentina’s exceptional access regime for pharmaceuticals, and medicinal cannabis. Practice head Ana Andrés is well regarded and recognised for her deep knowledge of healthcare regulation. Senior associate Malvina Acuña focuses on healthcare and life sciences and handles a mix of transactional, corporate and company law work.

Responsables de la pratique:

Ana Andrés


Les références

‘The practice provides effective and business-oriented advice that is responsive to the needs of the client’

‘Ana Andrés leads the team in a professional and cost-effective manner.’

‘The team has good knowledge of sector regulations and there is effective coordination between the firm’s specialist lawyers.’

Principaux clients

GlaxoSmithKline/Haleon


Abbvie


Biomarin


Cámara Argentina de Especialidades Medicinales


PTC Therapeutics


Sanofi Group


B Braun Medical


Biosidus


Penumbra


GSK Biopharma


No Pausa


Vertex Pharmaceutical


Principaux dossiers


  • Advised and assisted Opella with the transfer of its Hidrotisona family of products to Eurofarma Brazil.
  • Advised Mega Labs on the acquisition of Dromex Biotech.

Bomchil

Clients turn to Bomchil for advice on clinical trials, telemedicine, healthcare regulation and tobacco-free products, as well clinical practice guidelines in the field of obstetrics and surrogate motherhood, and liability management. The team is particularly well known for handling complex medical malpractice cases and providing pre-trial counsel to mitigate claims risk. The practice is led by Melisa Romero, who has extensive experience of handling medical malpractice proceedings and also advises clients on claims and cases related to adverse effects arising from Covid-19 vaccines and clinical trials. Senior associate María Victoria Casale has played a key role in managing obstetrics and neonatology malpractice cases.

Responsables de la pratique:

Melisa Romero


Les références

‘Highly qualified professionals with deep sector knowledge. They are focused on satisfying the client.’

‘They are very attentive and efficient. They respond quickly. They are committed to their work.’

Principaux clients

Biosidus


Fundacion Huésped


Medicus


Llamando al Doctor


PPD Argentina


Sanatorio Otamendi y Miroli


Sanatorio Las Lomas


Tuteur


Principaux dossiers


  • Advising Sanatorio Otamendi y Miroli on a birth malpractice case, which involves complex interpretation of obstetrics and neonatology medical guidelines.
  • Advised Sanatorio Las Lomas in a medical malpractice case arising from a misdiagnosis.

Bruchou & Funes de Rioja

Bruchou & Funes de Rioja advises clients in the pharmaceutical, health, personal hygiene, cosmetics, biotechnology and medical device industries, and covers commercial agreements, strategic partnerships, litigation and M&A, as well as trade mark, patent and other IP matters. The practice is co-led by respected corporate and M&A partner Estanislao Olmos, who focuses on M&A and commercial agreements in the sector, and IP lawyer Dámaso Pardo, who has extensive experience in filing and prosecuting patent applications for pharmaceutical, medical device and biotechnology companies. Administrative law and regulatory expert Juan Zocca works on regulatory matters related to medicinal cannabis, drugs, healthcare and health technologies, and regularly supports clients in the registration of products and companies before ANMAT, and with the application of the chemical precursors regime to pharmaceutical companies.

Responsables de la pratique:

Estanislao Olmos; Dámaso Pardo


Principaux clients

Laboratorio Elea Phoenix


Tecme


Framingham Pharma


WeFiv


Laboratorios Bagó


Cinven Group


Metagenics


West Pharmaceutical Services


Boston Scientific


Natura


Coty


Cosméticos Avon


Auditron


Siemens Healthineers


Roemmers


Gador


Fresenius Medical Care


Droguería Suizo


Principaux dossiers


  • Providing ongoing assistance to pharmaceutical company Laboratorios Elea Phoenix on all its legal matters, including its regional expansion, strategic partnerships with international players, and key legal challenges in Argentina.
  • Advising Chilean brewing company CCU on a wide variety of regulations on food products related to its daily operations, such as labelling, classification and advertisement regulations needed to carry out its activities in Argentina.
  • Advising Cargill on a wide variety of corporate, international trade and customs, environment, and logistics legal matters related to the daily operations of its agribusiness and food production business.