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    Regulation of the Australian online pharmacy
     
    Contact: Beth Turnbull  of  Allens Arthur Robinson
     
    Internet selling

    Anyone who uses the Internet will be aware of the explosive growth of online advertisements for pharmaceuticals. There is no end to websites through which consumers may purchase medicines online for pick-up or, more commonly, home delivery by mail or courier.

    'Bricks and mortar' pharmacies have long been the subject of strict statutory regulation, but online pharmacists pay little regard for local laws applying to their operations. Although there is currently no regulation expressly directed at online pharmacies, many of the existing requirements applying to physical pharmacies will also apply to those operating online. Some of the more significant requirements at both the State and Federal level include:

  • Pharmacists must be registered in the State or Territory in which they are practising and practise in approved premises.


  • Certain drugs may be dispensed without a prescription only if the pharmacist ensures the existence of a therapeutic need for the medicine. The pharmacist is also often required to personally hand the medicine to the consumer and counsel the consumer on appropriate use.


  • Prescription-only medicines may be dispensed only on presentation of an original physical prescription signed by hand by a doctor holding an Australian provider number. Online pharmacies have attempted to deal with this by requiring the prescription to be posted to the pharmacy or handed to the courier in return for the medicine.


  • Some States and Territories prohibit dispensing prescriptions written by doctors not registered in the State or Territory, making it difficult for online pharmacies to fill prescriptions from outside the jurisdiction.
    Restrictions on the export of prescription drugs require that they only be taken or sent overseas for personal use, resulting in some online pharmacies refusing to accept orders for prescription drugs from outside Australia.


  • Some State Pharmacy Boards include in their Guidelines for Good Pharmaceutical Practice guidelines for dispensing at a distance, contravention of which may attract penalties for registered pharmacists, including suspension.

    Prescription drugs and certain pharmacy-only medicines cannot be advertised. There is a requirement that advertisements for drugs that may be advertised require approval in relation to 'specified media' (includes radio and television), but the position in relation to Internet advertising is unclear. All advertisements, including those on the Internet, must comply with the more general provisions of the Therapeutic Goods Act, Therapeutic Goods Advertising Code, Trade Practices Act and Fair Trading Acts.

    Although the application of regulations drafted with 'bricks and mortar' pharmacies in mind to online pharmacies is not without its complications and uncertainties, until more comprehensive and Internet-specific regulations are in place, the pharmaceutical industry must attempt to work within the current structure as best it can.
    September, 2003

     

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