Eye on the Ball

Medicine regulation – not IP enforcement – can best deliver quality medicines

Published: 2 February 2011

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.
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