Date: 2 February 2011
Source: Oxfam International
Link: http://www.oxfam.org/en/policy/eye-ball.
Poor-quality, or “substandard”, medicines threaten patients and public
health in developing countries. Prioritization of medicines regulation by
developing-country governments, with the technical and financial support of
rich countries, is badly needed.
Under the guise of helping to address dangerous and ineffective medicines,
rich countries are pushing for new intellectual-property rules and reliance on
police – rather than health regulatory – action.
This approach will not ensure that medicines consistently meet quality
standards. Worse, new intellectual property rules can undermine access to
affordable generic medicines and damage public health. Developing countries
must improve medicines regulation – not expand intellectual-property
enforcement – in order to ensure medicine quality.
Recommendations
Developed-country governments should:
- Expand funding and support for national and regional initiatives that
increase the ability of drug-regulatory authorities in developing
countries to protect their populations from harmful products.
- Stop pursuing TRIPS-plus enforcement measures (intellectual property
rules that exceed minimum obligations under global trade rules) 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 drug-regulatory authorities` capacity together with the
provision of free essential medicines.
- Promote generic competition in national medicines policies, including
implementation of TRIPS flexibilities in national laws. Reject initiatives
modeled on ACTA, and any other TRIPS-plus enforcement initiatives.
The World Health Organization should:
- Prioritize the WHO`s comprehensive program 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 drug-regulatory
authorities; and investment in and expansion of the WHO prequalification
program.
- The WHO should disband IMPACT. The WHO should also 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.
Pharmaceutical companies should:
- Adhere consistently to WHO quality standards. Companies must not
produce substandard medicines for export to low-income countries, and they
must fulfill 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.
Keywords: Medicines
/ IP / WHO
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