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  • 1.

    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.

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

  • 3.

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

  • 4.

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

  • 5.

    What is the scope of their enforcement and regulatory responsibilities?

  • 6.

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

  • 7.

    What is the scope of their enforcement and regulatory responsibilities?

  • 8.

    Which other agencies have jurisdiction over healthcare, pharmaceutical and medical device cases?

  • 9.

    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.

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

  • 11.

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

  • 12.

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

  • 13.

    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.

    Through what proceedings do agencies enforce the rules?

  • 15.

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

  • 16.

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

  • 17.

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

  • 18.

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

  • 19.

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

  • 20.

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

  • 21.

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

  • 22.

    How are the rules enforced?

  • 23.

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

  • 24.

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

  • 25.

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

  • 26.

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

  • 27.

    Through what proceedings do agencies enforce the rules?

  • 28.

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

  • 29.

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

  • 30.

    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.

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

  • 32.

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

  • 33.

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

  • 34.

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

  • 35.

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

  • 36.

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

  • 37.

    Are there any compensation schemes in place?

  • 38.

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

  • 39.

    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.

    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.

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

  • 44.

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

  • 45.

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

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Established in 1825 in Dublin, Ireland and with offices in Cork, London, New York, Palo Alto and San Francisco, more than 700 people work across Matheson’s six offices, including 96 partners and tax principals and over 470 legal and tax professionals.

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70 Sir John Rogerson’s Quay
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