Keeping an 'Eye on the Ball': Oxfam responds

A disproportionate amount of attention and resources is being directed towards anti-counterfeit initiatives, says Oxfam in a response to our review of its 'Eye on the Ball' report on medicine quality in developing countries.

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The article entitled "Oxfam’s Trademark Confusion" by Philip Stevens mischaracterises key messages in the Oxfam briefing paper "Eye on the Ball,"  at the same time grossly exaggerating the role of IP enforcement - as opposed to health regulation - in ensuring medicines safety and quality. 

The suggestion that countries should enforce trademarks, trusting that because companies "jealously guard their reputations" they will sell only high quality products, is misguided. 

Instead, an approach centred on effective risk-based oversight of pharmaceutical entities and products is needed to ensure that medicines are consistently safe, effective, and of quality. This approach should be accompanied by policies to promote affordability, including the provision of free medicines by public clinics.

Although it cannot be the centrepiece of a strategy to ensure a sound medicines supply, Oxfam does not consider enforcement of trademarks to be "irrelevant" to this objective. Criminal trademark infringement, also known as "counterfeiting," is the deliberate, fraudulent use of a protected mark on a commercial scale without the consent of the owner. Such activity should be prosecuted.  Counterfeit medicines, which are intended to deceive consumers and which unfairly undermine the reputations of legitimate manufacturers, should never be on the market. 

Available evidence indicates that counterfeits are not the primary source of potentially unsafe and ineffective medicines in developing-country markets.  Substandard and falsified medicines (most of which do not infringe intellectual property) are considered by public health experts to be a far more widespread threat to public health.  The threat is particularly acute in developing countries with weak or no regulatory capacity. Some countries are unable even to maintain a register of medicines that have been approved for sale in the country, much less to effectively monitor what is produced, imported, traded, and consumed. 

Governments cannot therefore rely on anti-counterfeit actions to protect their populations, as these only address a subset of the bigger problem of unsafe or poor quality medicines.  Moreover, if drafted too broadly, anti-counterfeit laws can be counterproductive to the goal of improving public health, by targeting lawfully available generic medicines for removal from the market.  Oxfam is alarmed by the broad anti-counterfeit measures that have been enacted in countries such as Kenya, in response to industry pressure and based on recommendations by industry-dominated initiatives such as the International Medical Products Anti-Counterfeiting Taskforce (IMPACT).

Developing-country governments are advised instead to enact proven, public health-based measures to ensure medicines safety and quality (collectively, "drug regulation").The Director General of the World Health Organization (WHO), Margaret Chan, recently confirmed that upgrading medicines regulatory capacity should be the primary strategy for ensuring that all medicines are safe, effective, and of quality:

"The WHO approach to address the problem in developing countries is the same as that used successfully by wealthy nations to protect their populations.  That is:  strict regulatory control of medicines on the market, strict enforcement of quality standards, and diligent pharmacovigilance.  Nothing suggests the need for a double standard."  

Oxfam is concerned that a disproportionate amount of attention and resources is being directed towards anti-counterfeit initiatives. At the same time, the much broader problem of non IP-infringing substandard and falsified medicines, together with the need to upgrade regulatory capacity in poor countries, has not been adequately addressed. 

Effective drug regulation is not the "icing on the cake" of a safe drug supply, as contended in Stevens' article.(3) It is the cake. This is confirmed by the continued expenditure of massive resources by developed countries to regulate the safety and quality of medicines:  for instance, over $1bn per year, in the case of the US Food and Drug Administration (FDA).  Such agencies do not depend on IP enforcement to ensure a safe medicines supply. 

Significant, predictable investments over the long term will be needed in order to protect patients in developing countries from substandard and other unsafe medicines.  Developing countries will need to upgrade the capacity of their national drug regulatory authorities (DRAs) to perform the range of necessary regulatory functions, including registration of medicines, inspection of manufacturing sites, quality control testing, risk-based inspections of pharmaceutical establishments, and pharmacovigilance. Continuing financial and political support for the WHO's important capacity-building and pre-qualification work will be central to building developing-country DRAs. And the severe lack of capacity at this time in many poor countries, and the difficult challenges that must be overcome in some places - including no laboratories, absence of trained personnel, and endemic corruption - should intensify rather than diminish the urgency of this task. 

Discussions in early March about WHO withdrawal from IMPACT constitute an important step towards the application of the appropriate framework - a health, rather than IP, framework - to analyze the problem of unsafe and poor quality medicines.  IMPACT recommendations conflate criminal and civil trademark infringement, and its broad definition of "counterfeit" could lead to criminalization of production and trade in legitimate generic products.  This outcome is unacceptable from a public health perspective.  Fortunately, IMPACT can no longer benefit from the legitimacy conferred by the participation of the WHO, to which many countries look for expert health advice and assistance with public health policies. 

Too many people in poor countries suffer needlessly because the medicines that are available to them are not safe, effective, and of the appropriate quality.  Overcoming this tremendous public health challenge will require well-crafted and balanced investments that target the sources and underlying causes of the problem.  Mr. Stevens’ diagnosis, by focusing almost only on trademark enforcement, while ignoring the critical and central role played by drug regulatory authorities to keep unsafe, ineffective, and/or poor quality medicines off the market, ignores the weight of evidence as well as the approaches that developed countries themselves have employed to ensure quality medicines. 

Oxfam recommends the following policies and actions to ensure that people in developing countries can access affordable medicines that are safe, effective, of the appropriate quality, and not falsified.

Developed-country governments should:

•    Expand funding and support for national and regional initiatives that increase the ability of DRAs in developing countries to protect their populations from harmful products. This includes building rigorous quality-assurance and pharmacovigilance functions, and expanding funding and support for WHO normative and technical work, including the WHO Prequalification Program.
•    Ensure the consistent application of quality control for all medicines procured with the use of donor funds, and the regular and transparent publication of quality-testing results.
•    Stop pursuing TRIPS-plus enforcement measures through internal regulations, multilateral trade initiatives, bilateral trade agreements, or through technical assistance.

Developing-country governments should:

•    Prioritize the expansion of public health-care infrastructure and invest in DRA capacity together with the provision of free essential medicines.  Some functions of national DRAs should be co-ordinated among groups of countries where there is a rationale and the will to do so.
•    Use new public and private investment to tighten the regulation of retail pharmaceutical outlets and to stop the sale of falsified and substandard medicines through informal and unqualified vendors.
•    Promote generic competition in national medicines policies, including implementation of TRIPS flexibilities in national laws.
•    Reject initiatives modeled on the Anti-Counterfeiting Trade Agreement (ACTA) and any other TRIPS-plus enforcement initiatives.

The World Health Organization should:

•    Prioritize the WHO’s comprehensive programme of work which underpins access to affordable, quality medicines for its Member States, including expansion of capacity and adequate funding to provide technical assistance to countries; support for the achievement of stronger national DRAs; and investment in and expansion of the WHO prequalification programme.
•    The WHO should withdraw from IMPACT, and should acknowledge that IMPACT has created unnecessary confusion, particularly through the misuse of the term ‘counterfeit’ to refer to substandard and falsified medicines that are unrelated to criminal trademark infringement, and through use of an IP framework to evaluate the public-health problem of unsafe medicines.
•    Support countries in implementing TRIPS safeguards and flexibilities, and reject TRIPS-plus IP measures that could undermine access to medicines.

Pharmaceutical companies should:

•    Adhere consistently to WHO quality standards.  Companies must not produce substandard medicines for export to low-income countries, and they must fulfil their responsibility to declare to purchasers the full provenance of products openly and transparently.
•    Recognize the damage inflicted on public health as a result of the confusion of quality with intellectual-property issues in initiatives such as IMPACT, and correct this fundamental error in their public statements and documents.

Jennifer Brant
Consultant to Oxfam

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1)  http://www.oxfam.org.uk/resources/policy/health/downloads/bp143-eye-on-the-ball-medicine-regulation-020211-en.pdf.
2) See DG Chan’s speech of 28 February 2011 at http://www.who.int/dg/speeches/2011/ncds_20110228
3) Oxfam's trademark confusion (/40/articles/857.php)