[Ip-health] Securing Pharma-Keeping an 'Eye on the Ball': Oxfam responds

Thiru Balasubramaniam thiru at keionline.org
Fri Mar 25 08:50:45 PDT 2011


http://www.securingpharma.com/40/articles/883.php

Keeping an 'Eye on the Ball': Oxfam responds

15-Mar-2011
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.

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


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)





------------------------------------------------------------


Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru at keionline.org


Tel: +41 22 791 6727
Mobile: +41 76 508 0997








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