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Life Sciences

Published: January 2020


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  • 1.

    How is healthcare in your jurisdiction organised?

  • 2.

    How is the healthcare system financed in the outpatient and inpatient sectors?

  • 3.

    Basic structures
    What are the basic structures of the provision of care to patients in statutory and private care?

  • 4.

    What steps are necessary to authorise the provision of health services, and what law governs this?

  • 5.

    Which types of legal entities can offer healthcare services?

  • 6.

    Requirements for foreign health services providers
    What further steps are necessary for foreign companies to offer health services?

  • 7.

    Which legislation governs advertising of medicinal products to healthcare professionals?

  • 8.

    Main principles
    What are the main rules and principles applying to advertising of medicinal products aimed at healthcare professionals?

  • 9.

    Advertising of medical devices
    Is the advertising of medical devices to healthcare professionals regulated as rigorously as advertising in the pharmaceuticals sector? What are the main differences?

  • 10.

    What are the legal developments regarding digitisation in the healthcare sector and industrial networks or sales channels?

  • 11.

    Provision of digital health services
    Which law regulates the provision of digital health services, and to what extent can such services be provided?

  • 12.

    Which authorities are responsible for compliance with data protection and privacy, and what is the applicable legislation? Have the authorities issued specific guidance or rules for data protection and privacy in the healthcare sector?

  • 13.

    What basic requirements are placed on healthcare providers when it comes to data protection and privacy? Is there a regular need for qualified personnel?

  • 14.

    Common infringements
    What are the most common data protection and privacy infringements committed by healthcare providers?

  • 15.

    Which legislation governs the collaboration of the pharmaceutical industry with healthcare professionals? Do different rules apply regarding physicians in the outpatient and inpatient sectors?

  • 16.

    Collaboration with healthcare professionals
    What are the main rules and principles applying to the collaboration of the pharmaceutical industry with healthcare professionals?

  • 17.

    Collaboration with patient organisations
    What are the main rules and principles applying to the collaboration of the pharmaceutical industry with patient organisations?

  • 18.

    Common infringements
    What are the most common infringements committed by pharmaceutical manufacturers regarding collaboration with healthcare professionals?

  • 19.

    Collaboration on medical devices
    Is the collaboration of manufacturers of medical devices with healthcare professionals and patient organisations regulated as rigorously as collaboration in the pharmaceuticals sector? What are the main differences?

  • 20.

    Authority enforcement
    Are infringements of competition law by healthcare providers pursued by national authorities?

  • 21.

    Private enforcement
    Is follow-on private antitrust litigation against healthcare providers possible?

  • 22.

    Anti-corruption and transparency
    What are the main anti-corruption and transparency rules applicable to healthcare providers?

  • 23.

    Price regulation
    To what extent is the market price of a medicinal product or medical device governed by law or regulation?

  • 24.

    Negotiations between manufacturers and providers
    Must pharmaceutical and medical device manufacturers negotiate the prices of their products with public healthcare providers?

  • 25.

    In which circumstances will the national health insurance system reimburse the cost of medicines?

  • 26.

    Price adjudication
    If applicable, what is the competent body for decisions regarding the pricing and reimbursability of medicinal products?

  • 27.

    Are manufacturers or distributors of medicinal products statutorily obliged to give a discount to health insurance schemes or third parties?

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SRS Advogados is a full-service, multi-practice law firm advising clients on all aspects of domestic as well as international law, with extensive experience in arbitration and mediation, competition and European Union, corporate and commercial, dispute resolution, employment and social security, energy, environmental, finance, immigration and Golden Visa, insurance and pensions, intellectual property, life sciences and healthcare, M&A, private equity and venture capital, projects, real estate, tax, transport and shipping and white-collar crime.

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