IndustriesHealthcare and pharmaceuticals

Legal support for healthcare and pharmaceuticals

We advise manufacturers of medicines and medical devices, healthcare institutions and digital health companies on registration and clinical trials, on advertising and on the processing of health data.

Contact us Areas of support
ALIMSthe competent agency for medicines and medical devices
Special categoryhealth data under a heightened protection regime
2 regimesmedicines and medical devices, with rules for digital health
Industry overview

Regulatory framework and supervision

Placing medicines and medical devices on the market requires a marketing authorisation or entry in the register, and clinical trials are conducted on the approval of the competent agency and the ethics committee.

Supervision focuses on the quality of documentation, safety monitoring, advertising towards healthcare professionals and the public, and the processing of health data.

Medicines and medical devicesMarketing authorisation and entry in the register.
Clinical trialsAgency and ethics committee approval, contracts with sites.
AdvertisingRestrictions for prescription medicines and rules for public communication.
HealthcareConditions for healthcare activity and patient consent.
Data protectionHealth data as a special category of personal data.
ProcurementPublic procurement procedures and contracting with institutions.
Our services

Most common areas of support

Six areas in which healthcare companies most often ask for legal support.

01

Registration and market access

  • Advice on product classification and the applicable regime.
  • Preparation and review of registration documentation.
  • Representation in proceedings before the competent agency.
  • Renewal of authorisations and notification of variations.
  • Import, distribution and wholesale conditions.
02

Clinical trials

  • Contracts with sites, investigators and contract research organisations.
  • Preparation of the approval dossier.
  • Informed consent forms and participant information.
  • Rules on processing and transferring participant data.
  • Liability, insurance and handling of injury claims.
03

Advertising and interaction with healthcare professionals

  • Review of promotional material before release.
  • Rules for public and for professional communication.
  • Consultancy, speaker and sponsorship agreements.
  • Transparency of transfers of value and internal compliance programmes.
  • Responding to complaints and supervisory orders.
04

Health data protection

  • Legal bases for processing health and genetic data.
  • Records of processing and data protection impact assessments.
  • Processor contracts and transfers to third countries.
  • Handling patient requests and incidents.
  • External data protection officer.
05

Digital health

  • Classification of software as a medical device.
  • Terms of use and allocation of responsibility with users.
  • Telemedicine and remote provision of services.
  • Application of artificial intelligence rules in healthcare.
  • Contracts with institutions and integration with health systems.
06

Disputes and liability

  • Liability for defective products.
  • Proceedings concerning medical error and compensation.
  • Proceedings before supervisory and inspection authorities.
  • Product recalls and public notification.
  • Protection of trade secrets and dossier data.
How we work

What working with us looks like

Four stages, from regulatory analysis to ongoing support.

01

Regulatory analysis

We establish which licences, approvals and documents the proposed business model requires.

02

Documentation

We prepare contracts, internal acts and policies and coordinate procedures before the competent authorities.

03

Implementation

We represent the client in proceedings and negotiations through to a decision or the signing of the contract.

04

Ongoing support

We track legislative changes, supervisory procedures and the obligations that arise during operations.

Common questions

Questions clients ask

When is software a medical device?

When it is intended for diagnosis, monitoring or treatment, according to the intended purpose set by the manufacturer. Classification determines the scope of documentation and the registration route.

Do clinical trials require more than one approval?

They do. Approval is required from the competent agency and from the ethics committee, and contracts with sites and arrangements for participant data are concluded in addition.

How may medicines be advertised?

Prescription medicines may not be advertised to the public. For other products advertising is permitted within the approved indications and with the prescribed warnings.

On what basis is health data processed?

Health data is a special category and may be processed only on the statutory grounds, with heightened safeguards and, as a rule, an impact assessment.

Who is liable for harm caused by a medical device?

Liability may fall on the manufacturer, importer or distributor, depending on the defect and the instructions for use. The relationship is settled by contracts along the supply chain.

Related industries

Other industries

Fintech and payment services Software and information technology Media and publishing Energy Retail and e-commerce Real estate and construction Transport and logistics Gambling
Next step

How can we help?

Describe your matter and we will point you to the lawyer who leads that industry.

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