Suspect Medicines: Innovate or Ban Generics?

Written by Andrew Rens on February 11th, 2013

Medicine supply chains can leak: safe genuine medicines can leak out and fake medicines can leak in. This is obviously a threat to public health which makes it all the more unfortunate that a genuine problem has been used in an attempt to prevent competition from generic medicines in some countries.

The linchpin of this attempt was the use of the word “counterfeit” to describe spurious medicines. The therianthropic term “counterfeit” entered the discussion about spurious medicines from an international intellectual property enforcement discourse where it was used in ever changing ways in Intellectual Property documents such as ACTA, to refer to a wide variety of activities that include trade mark infringement.*

For example the World Health Organisation International Medical Products Anti-Counterfeiting Task Force (WHO IMPACT) claimed that counterfeit medicines “may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient or too much active ingredient, or with fake packaging.” **

According to this description of counterfeit medicines a medicine might be counterfeit even if it has the right ingredients in the right quantities but has “fake” packaging”. The definition thus includes generic medicines when there is a dispute about the trademark relating to the medicine. German customs officials, apparently unable to distinguish between the International Non Proprietary Name and a trademark have intercepted medicines in transit to a least developed country and defended their actions by claiming a concern about counterfeit medicines.

Kenya, relying on international experts passed anti counterpointing legislation that was subsequent struck down by the High Court because it effectively label generic medicines as counterfeit and thus threatened the right to health.

If those are the wrong approaches to spurious medicines there are far more innovative approaches such as Sproxil. A consumer can scratch a ticket and then text a unique number to Sproxil which would then confirm the authenticity of the product. This system works in developing countries with low Internet penetration but where cell phones are widespread.

* Unravelling the full etymology of ‘counterfeit’ will have to wait for another day.

** WHO IMPACT has subsequently begun to use the term SFFC (spurious/falsely-labelled/falsified/counterfeit) medicines.

 

Notice and Take Down or Notice and Notice and Take Down?

Written by Andrew Rens on November 30th, 2012

South Africa currently has a notice and take down regime for online content. Service providers which cache content are able to avoid liability if they comply with the provisions of the 2002 Electronic Communications and Transactions Act, specifically section 77 which required them to take down content on receipt of a take down notice that had specific information.

Obviously that provision was unconstitutional since it enabled private person to effectively remove speech that he did not agree with from public view. The South African Department of Communications has proposed am mending the provision by including a new provision, section 77A to the proposed Electronic Communications and Transactions Act Bill.

The proposed set up is that a complainant would send a notice to a service provider which would be obliged to reply to at least the grounds of the complaint. The complainant would then decide if he was satisfied and if not send a final notice of take down whereupon the service provider would have to take the content down or lose its protection from liability.

The rationale for the proposed amendment is set out in the Explanatory Memorandum (available at MyBroadband but not on the DoC site)

” 12.5 After further consideration, the Minister considers that any notice or take-down procedure should allow for the right of reply in accordance with the principle of administrative justice and the audi alteram partem rule. Changes have been proposed in this regard to section 77 and a new section 77A is proposed.”

Of course a provision that requires an ISP to answer to a complainant but does not give notice or an opportunity to respond to the content provider does not comply with the audi alteram partem (hear the other side) rule at all. The proposal is as unconstitutional as the current section. A notice and notice provision such as that about to be adopted by Canada seems as if it would be a better fit for South Africa.

Submissions to the Department of Communications on the Bill can be made by 7 December 2012. They can be addressed to: palesa@doc.gov.za