New Enforcement Mechanisms Challenge the Legality of Generics in the Name of Public Health: The Emergence of Anti-Counterfeiting Legislation in East Africa
| Pages | 238-253 |
| Published date | 01 September 2010 |
| Author | Johanna Von Braun,Peter Munyi |
| DOI | 10.3366/ajicl.2010.0007 |
| Date | 01 September 2010 |
In addition to substantive changes to intellectual property law put forward through a range of different mechanisms at the international, regional and national level over the last few years, another TRIPS-plus trend has emerged. This new trend seeks to increase the level of enforcement of intellectual property law in national jurisdictions in two broad ways. The first, aiming to deter piracy, seeks to increase the level of penalty associated with, for example, copyright infringement or the distribution of pirated goods. It also includes the empowerment
Some of the powers given to customs officials include destroying the seized goods.
of custom officials to engage in border inspections with or sometimes even without (The second, which is the subject of this paper, is the inclusion of traditionally exempted forms of intellectual property rights (IPRs), such as patents and plant breeders’ rights into anti-counterfeiting legislation. The result of this ‘substantive expansion’ of the use of the term ‘counterfeit’ is a possible confusion over the status of perfectly legal generic products such as medicines which may result in them being placed in the same category as illegally pirated goods. As a consequence, generic medicines have become repeatedly subject to seizure and their producers have to fear prosecution. The expansion of such measures will have serious consequences on the availability of affordable medicines in developing countries. While the problem of substandard and counterfeit medicines is grave and has drastic impacts on public health, dealing with it by broadening the concept of counterfeits is likely to have the opposite effect.
In June 2008, the Merchandizing Marks Regulations
These regulations were made pursuant to the provisions of the Merchandizing Marks Act 1963.
were promulgated with a view to make provision for dealing with counterfeiting problems in Tanzania. Kenya followed suit in December 2008, with the enactment of a national legislation on anti-counterfeiting. Uganda and the others in the region are following suit.Business Daily, ‘EA edges closer to having common laws on fake goods’ (10 March 2010), available at
Kenya is a developing country whereas Uganda is an LDC.
Part III of the TRIPS Agreement describes the minimum standard for the enforcement of IPRs. It complements the substantive sections of the TRIPS Agreement by establishing general standards of enforcement to be implemented according to the method of choice by each member state. Although the scope for enforcement is broad and includes, for example, border measures, the more drastic of these measures tend to apply only to certain types of IPRs involving specifically trademarks and copyrights.
In general, Arts 41–9 provide for civil and administrative procedures in cases of IPR infringement, including injunctions, damages and remedies that should guide member states on how to deal with IPR infringement at the national level.
These remedies include national courts and administrative procedures.
The TRIPS Agreement furthermore provides for border measures that shall be implemented, but only in references to trademark counterfeit and copyright pirated goods.
Art. 51 calls on member states to enable a right holder, ‘who has valid ground for suspecting that the importation of counterfeit trademark or pirated copyright goods has taken place’, to complain to relevant authorities so that custom officials may prevent the release of such products into free circulation.
However, members are not obliged to implement measures that allow custom officials to seize products, based onThe application of criminal procedures is limited. Art. 61 calls for criminal procedures to be applied in cases of ‘wilful trademark counterfeiting or copyright piracy on a commercial scale’. The remedies prescribed in criminal procedures are more severe: imprisonment and/or monetary fines, seizure, forfeiture or destruction of the wilfully infringing goods.
Arts 51 and 61 highlight that border measures and related criminal procedures are only obligatory in the case of counterfeit trademarks and pirated copyright goods. Members are under no obligation to apply them to other fields of intellectual property, such as geographical indications, plant varieties protection and patents.
The TRIPS Agreement deliberately distinguished between trademark counterfeits and copyright piracy and other forms of IPRs. One of the reasons leading to this distinction is because at the time of the negotiations members were aware that IPR infringement in a field such as patents is less obvious than in trademarks, and often subject to lengthy litigation that may even result in claiming the original patent invalid. Indeed, claiming a patent invalid, often for reasons such as overly broad claims, is considered a viable business method most common in countries such as the United States. It does not necessarily imply criminal intent. This is not the case in trademark and copyright infringement.
Footnote three of TRIPS Art. 51 provides us with a definition for counterfeit goods:
For the purpose of this Agreement:
‘counterfeit trademark goods’ shall mean any goods, including packaging, bearing without authorization a trademark which is identical to the trademark validly registered in respect of such goods, or which cannot be distinguished in its essential aspects from such a trademark, and which thereby infringes the rights of the owner of the trademark in question under the law of the country of importation.
Therefore, counterfeit medicines in the context of the TRIPS Agreement refer to medicines that by means of either a false label or packaging are ‘passed of’ as the original medication. One obvious result is that counterfeit drugs bypass the safety and efficacy scrutiny of drug regulatory authorities. It is this intent to wilfully ‘fool’ consumers and drug regulatory authorities that essentially defines the concept of counterfeit medicines.Counterfeit medicines exist not only of R&D or brand name companies, but equally occur as counterfeits of generic firms and labels. They tend to emerge from illegal and clandestine laboratories, often misinforming about the source of the produce, reducing the quality of active ingredients, not including them at all or, in the worst cases, replacing them with other material. The resultant product is ‘falsely labelled’ or ‘misbranded’ and, as it bypasses national drug safety mechanisms, often ineffective or counter-effective.
Counterfeit or falsely labelled medicines are also not to be confused with substandard medicines. Substandard drugs are medicines whose composition and ingredients do not meet the correct scientific specifications according to the World Health Organization (WHO), do not fool consumers due to misbranding or misinforming about source and producer, but often contain an over- or under-concentration of ingredients, are of poor-quality ingredients, lack stability or are damaged due to inadequate packaging, storage or transport. Substandard medicines are mostly a result of low manufacturing standards and/or weak regulatory agencies and oversight.
Health Action International (HAI) ‘What are “counterfeit”, “generic” and “substandard” medicines?’ HAI Fact Sheet, 2008, Nairobi, Kenya.
Both counterfeit and substandard medicines constitute two of a series of public health problems in developing countries that need to be addressed. The gravity of these problems varies among and within countries, and very little real and objective data exist that provide a clear picture of the percentage of falsely labelled medicines on national markets.
WHO SEARO,
Based on the working definition of the first international meeting on counterfeit medicines held in 1992 at the WHO, the WHO Secretariat defines counterfeit medicines as:
a medicine which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply both, branded and generic products and counterfeit products may include products with the correct ingredient or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.
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