[Ip-health] Securing Pharma-Keeping an 'Eye on the Ball': Oxfam responds
thiru at keionline.org
Fri Mar 25 08:50:45 PDT 2011
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
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,
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
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
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
• 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
• 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.
Consultant to Oxfam
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)
Knowledge Ecology International (KEI)
thiru at keionline.org
Tel: +41 22 791 6727
Mobile: +41 76 508 0997
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