Medicinal products and medical devices

We combine expertise with long-term experience in assisting clients from the pharmaceutical and medical devices sectors. We deliver complex legal services to manufacturers’ of medicines and medical devices and to companies selling these products in Poland. We provide support in those areas in which it is most required, first of all in regulatory matters and compliance, but also in commercial contracts and public tenders.

Reimbursement of medicinal products, medical devices and food for special nutritional purposes is our key expertise. We can provide assistance in particular in:

  • Drafting letters, applications and appeals to the authorities responsible for reimbursement, in particular, to the Minister of Health
  • Drafting and negotiating Risk Sharing Schemes (RSS)
  • Preparations to the negotiations, determining a negotiations strategy; attending the meetings with the Economic Commission
  • Reviewing drafts of the therapeutic programmes, assistance in agreeing their content with the Minister of Health
  • Explaining terms and provisions of the reimbursement regulations; assistance in their application in practice
Promotion and advertising is a particularly sensitive area, bearing in mind detailed regulations, ethical guidelines and risk of holding of certain promotional activities as breaching anti-bribery regulations. Matters in which we provide advice are:

  • Review of marketing and sales activities under the pharmaceutical laws and regulations and ethical codes and guidelines (the Pharmaceutical Industry Code of Good Marketing Practices, Interactions with Healthcare Professionals and Patient Organisations, the Eucomed Code)
  • Review of promotional materials, including TV spots, sponsorship spots, brochures, gadgets, under the above mentioned regulations and guidelines
  • Relationships, contacts and agreements concluded by the industry with healthcare professionals
  • Sponsorships, terms of financing by the industry of healthcare professionals’ attendance of congresses
  • Representing clients in front of the Chief Pharmaceutical Inspector in matters relating to alleged breaches of the requirements on promotion and advertising
  • Replies to claims made by competitors
  • Unfair and prohibited advertising under unfair competition regulations
  • Trade marks

We draw special attention to compliance, being aware of care of the pharmaceutical and medical devices sectors for maintaining highest ethical standards and their exposure to the interests of media, if any irregularities in this area are identified. We deal in particular with:

  • Reviewing drafts and projects of any agreements, promotional campaigns, studies (including non-interventional, observational, and similar) to ensure compliance with legal regulations and applicable ethical standards (Polish laws and regulations, the INFARMA Code, the Eucomed Code)
  • Reviewing the above drafts and projects to ensure required transparency and compliance of terms of payment to healthcare professionals with regulatory requirements, ethical guidelines and corporate procedures
  • Reviewing anti-bribery clauses under applicable requirements (including FCPA) and corporate procedures
  • Reviewing and localising procedures preventing bribery
  • Audits of documents and marketing and sales activities under regulatory and ethical regulations and guidelines

To place a new product on the market, or to authorise in particular a new indication, complex clinical trials are required, which assess among others safety and efficacy of the investigated product. Similarly, clinical trials are required for a clinical evaluation of active implantable, implantable and class III medical devices. Apart from clinical trials, companies often carry out non-interventional, observational and other post-marketing studies. We assist in:

  • Reviewing and redrafting clinical trials agreements and agreements on other kinds of studies, with respect to legal and corporate requirements and commercial terms:
    • between the sponsor and investigational team members
    • between the sponsor and CRO
    • between CRO and investigators
    • agreements with sites
    • agreements on diagnostic services
  • Negotiating agreements with study sites, investigators and diagnostics sites
  • Counselling on the requirements of the Good Clinical Practice and other regulatory requirements
  • Reviewing forms used in clinical trials (e.g., informed consent forms)
  • Compliance in clinical trials
  • Advising on how the costs of certain healthcare services and products administered to clinical trials participants should be split between the sponsor and the public payer (NFZ) of (e.g., costs of escape therapy)
  • Obtaining a clinical trial authorisation
  • Counselling on payments due to ethic committees

In relation to the distribution, we provide our advice in:

  • Reviewing and drafting distribution agreements, with respect to the regulatory requirements (Good Distribution Practice), competition law (with the support of our friend law firm specialising in competition law) and commercial aspects
  • Reviewing and drafting consignments stock agreements
  • Negotiation with the wholesalers and distributors
  • Advice on the regulatory requirements applicable to pharmaceutical wholesalers and wholesale distribution authorisations

In relation to the manufacturing, we provide our advice:

  • In drafting and negotiating manufacturing and supply agreements
  • On the requirements of Good Manufacturing Practice
  • On regulatory aspects of manufacturing authorisations
We review, draft and negotiate agreements:

  • With healthcare professionals, nurses, consultants
  • With PR and advertising agencies, HTA agencies
  • Distribution and consignment stock agreements
  • Clinical trials agreements
  • Outsourcing agreements
  • Lease agreements

We also provide assistance in:

  • Reviewing General (Standard) Terms
  • Drafting template agreements, including instructions to complete these
  • Contractual clauses on the transfer of copyrights or other IP rights and licences
  • Clauses on data privacy
Our assistance includes or concerns:

  • Providing advice in relation to marketing authorisations (national, MRP, decentralised and centralised procedures)
  • Change of the marketing authorisation holder
  • Sunset clause
  • Names of medicines products
  • Regulatory data protection (data exclusivity), market exclusivity, innovative versus generic medicines
  • Orphan drugs
  • Biosimilars
  • Direct import
  • Borderline products
We provide counselling mainly on public contracts awarded by the contracting authorities from the healthcare sector, including:

  • Assessment of the admissibility of the requirements determined by contracting authorities
  • Selection criteria other than the price
  • Terms of applying particular procedures, including restricted procedures
  • Appeals
  • Terms of modifications of already executed public contracts

Pro-health food

We provide advice to manufacturers of dietary supplements and food for special nutritional purposes.

We assist in particular in:

  • Notification obligations of a food business operator
  • Registration and approval of establishments
  • Labelling and packaging
  • Health and nutrition claims
  • Reimbursement of food for special nutritional purposes
  • Licences, transfer of rights – drafting and negotiating agreements
  • Manufacturing – regulatory aspects