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  • 1.

    Healthcare funding
    In general terms, how is healthcare, including access to medicines and medical devices, funded in your jurisdiction? Outline the roles of the public and private sectors.

  • 2.

    Delivery
    In general terms, how is healthcare delivered in your jurisdiction? Outline the roles of the public and private sectors.

  • 3.

    Key legislation
    Identify the key legislation governing the delivery of healthcare and establishing the regulatory framework.

  • 4.

    Healthcare agencies
    Which agencies are principally responsible for the enforcement of laws and rules applicable to the delivery of healthcare?

  • 5.

    Scope of enforcement
    What is the scope of their enforcement and regulatory responsibilities?

  • 6.

    Pharmaceutical and medical devices agencies
    Which agencies are principally responsible for the regulation of pharmaceutical products and medical devices?

  • 7.

    Scope of enforcement
    What is the scope of their enforcement and regulatory responsibilities?

  • 8.

    Other agencies
    Which other agencies (eg, competition or securities regulators, prosecutors) have jurisdiction over healthcare, pharmaceutical and medical device cases?

  • 9.

    Simultaneous investigations
    Can multiple government agencies simultaneously conduct an investigation of the same subject? Does a completed investigation bar another agency from investigating the same facts and circumstances?

  • 10.

    Monitoring powers
    What powers do the authorities have to monitor compliance with the rules on drugs and devices?

  • 11.

    Investigation time frames
    How long do investigations typically take from initiation to completion? How are investigations started?

  • 12.

    Access to investigation materials
    What rights or access does the subject of an investigation have to the government investigation files and materials?

  • 13.

    Investigations abroad
    If pharmaceutical products or medical devices are made in a foreign country, may the authorities conduct investigations of the manufacturing processes in that other country?

  • 14.

    Enforcement proceedings
    Through what proceedings do agencies enforce the rules?

  • 15.

    Sanctions
    What sanctions and other measures can the authorities impose or seek in enforcement actions against drug and device manufacturers and their distributors?

  • 16.

    Actions against employees
    Can the authorities pursue actions against employees as well as the company itself?

  • 17.

    Defences and appeals
    What defences and appeals are available to drug and device company defendants in an enforcement action?

  • 18.

    Minimising exposure
    What strategies should companies adopt to minimise their exposure to enforcement actions and reduce their liability once an enforcement action is under way?

  • 19.

    Recent enforcement activities
    What have the authorities focused on in their recent drugs and devices enforcement activity and what sanctions have been imposed?

  • 20.

    Self-governing bodies
    Are there self-governing bodies for the companies that sell pharmaceutical products and medical devices? How do those organisations police members’ conduct?

  • 21.

    Relationship rules
    What are the rules prohibiting or controlling the financial relationships between healthcare professionals and suppliers of products and services?

  • 22.

    Enforcement
    How are the rules enforced?

  • 23.

    Reporting requirements
    What are the reporting requirements on such financial relationships? Is the reported information publicly available?

  • 24.

    Authority powers
    What powers do the authorities have to monitor compliance with the rules on delivery of healthcare?

  • 25.

    Investigation time frames
    How long do investigations of healthcare providers typically take from initiation to completion? How are investigations started?

  • 26.

    Access to investigation materials
    What rights or access does the subject of an investigation have to the government investigation files and materials?

  • 27.

    Enforcement agencies
    Through what proceedings do agencies enforce the rules?

  • 28.

    Sanctions
    What sanctions and other measures can the authorities impose or seek in enforcement actions against healthcare providers?

  • 29.

    Defences and appeals
    What defences and appeals are available to healthcare providers in an enforcement action?

  • 30.

    Minimising exposure
    What strategies should healthcare providers adopt to minimise their exposure to enforcement actions and reduce their liability once an enforcement action is under way?

  • 31.

    Recent enforcement activities
    What have the authorities focused on in their recent enforcement activity and what sanctions have been imposed on healthcare providers?

  • 32.

    Self-governing bodies
    Are there self-governing bodies for healthcare providers? How do those organisations police members’ conduct?

  • 33.

    Remedies for poor performance
    What remedies for poor performance does the government typically include in its contracts with healthcare providers?

  • 34.

    Causes of action
    What private causes of action may citizens or other private bodies bring to enforce a healthcare regulation or law?

  • 35.

    Framework for claims
    What is the framework for claims of clinical negligence against healthcare providers?

  • 36.

    Seeking recourse
    How and on what grounds may purchasers or users of pharmaceuticals or devices seek recourse for regulatory and legal infringements?

  • 37.

    Compensation
    Are there any compensation schemes in place?

  • 38.

    Class and collective actions
    Are class actions or other collective claims available in cases related to drugs, devices and provision of care?

  • 39.

    Review
    Are acts, omissions or decisions of public and private institutions active in the healthcare sphere subject to judicial or administrative review following a complaint from interested parties?

  • 40.

    Whistleblowers
    Are there any legal protections for whistleblowers?

  • 41.


    Does the country have a reward mechanism for whistleblowers?

  • 42.


    Are mechanisms allowing whistleblowers to report infringements required?

  • 43.

    Cooperation with foreign counterparts
    Do prosecutors and law enforcement authorities in your country cooperate with their foreign counterparts in healthcare cases?

  • 44.

    Triggering investigations
    In what circumstances will enforcement activities by foreign authorities trigger an investigation in your country?

  • 45.

    Pursuing foreign entities for infringement
    In what circumstances will foreign companies and foreign nationals be pursued for infringements of your country’s healthcare laws?

  • Updates and trends

LexCase started life in 2009 as an entrepreneurial project: to establish a multidisciplinary law firm and having close links with foreign law firms. Its departments assist its private, business and public sector clients in the implementation and the success of their projects, notably in areas requiring specific sector local expertise and in-depth knowledge of the regulatory environment.

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