Dilanchian Lawyers & Consultants
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Viagra_pills

Regulations framework for e-commerce pharmaceuticals

What is the law in Australia for selling Viagra or Cialis online? Many internet sites now offer customers the opportunity to purchase these and other pharmaceuticals online - usually at a considerable discount compared to prices quoted by off-line retail pharmacies in shopping strips and shopping malls.

E-commerce businesses offering pharmaceuticals from online shopping sites with Australian domain names or that operate within Australia, and who are not pharmacies themselves, need to be mindful of the complex and somewhat grey law governing the online marketing, advertising and sale of pharmaceuticals in Australia.

 

Regulations framework

Under Australia’s Standard for the Uniform Scheduling of Drugs and Poisons, only pharmacies may sell medicines that are scheduled as "poisons".

Manufactures or sponsors of Scheduled pharmaceuticals accordingly must label their products as either "S2", "S3" or "S4", denoting that they are respectively either:

  • "pharmacy only",
  • "pharmacist only", or
  • "prescription" medicines.

Unscheduled medicines may be sold from any point of sale. They include pharmaceuticals thought to be of low risk and toxicity - such as small packets of analgesics - commonly sold in Australia through supermarkets and convenience stores.

Products of interest to e-commerce, online or internet ventures for sale are more likely to be pharmacy-controlled S2 and S3 "over the counter" pharmaceuticals or S4 prescription pharmaceuticals. These offer the greatest potential for price competition - especially prescription products not listed on Australia’s Pharmaceutical Benefits Scheme and which are not therefore subject to a Government-controlled dispensed price. As the Government does not pay a benefit on these pharmaceuticals, customers are liable for their full cost. Examples include popular drugs used to treat impotence such as Cialis and Viagra. Any saving that can be made by purchasing these drugs from the cheapest source hence accrues directly to consumers.

Connection with Australia

viagra_moleculeAlthough Australian internet sites compete with sites in other locations that may offer Viagra and the like at prices below those quoted by Australian sites, it seems risk-averse consumers are not likely to buy on price alone from non-Australian sites.

These cautious consumers may prefer to pay a premium to deal with a business:

  • using an Australian domain name,
  • with a contact address in Australia, and
  • that is consequently obliged to sell pharmaceuticals sourced from an Australian sponsor.

This is because consumers can be sure any product so purchased satisfies the stringent quality criteria that are required by Australia’s Therapeutic Goods Administration (TGA).

The corollary for sellers of such products is that under Australia’s Price Information Code, any pharmaceutical offered by an Australian internet site must be approved for marketing in Australia as evidenced by their inclusion in the Australian Register of Therapeutic Goods.

Practical consequences and alternative strategies

There are many practical consequences from the fact that Australia’s Therapeutic Goods Act 1989 (Cth) prohibits some "pharmacist only" and all prescription pharmaceuticals (S3 and S4 scheduled products) that are listed on Australian internet sites (or in other media) being directly advertised to consumers.

In our firm, working with industry specialists, we have developed a detailed list of these practical consequences in working with clients for compliance with Australian law and regulations for sale of pharmaceuticals. There are also certain strategies which for the right business can result in development of a business structure and arrangements which minimise exposure to the extremes of a regulatory regime in Australia that is regarded by many as the most stringent in the world.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Practical consequences


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