Aug 2014

From Ebola to Medical Fraud: Ignorance is never bliss

Reports coming out of Liberia talk of Ebola patients being “rescued”, and materials looted, from a facility in the capital Monrovia.  Some of these patients and items are likely to end up in the capitals largest slum, increasing the chances that Ebola will spread rapidly through the capital.

One local police officer told the BBC: "This is one of the stupidest things I have ever seen in my life". "All between the houses you could see people fleeing with items looted from the patients." The BBC also reported that the assault on the clinic, mostly by young men armed with clubs, shouted insults about President Ellen Johnson Sirleaf and yelled "there's no Ebola".

Unsurprisingly health workers fled, this being just the latest attack on their efforts to contain the lethal virus that has so far killed roughly 55% of the over two thousand patients who tested positive.

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UNODC Failing to Tackle Substandard Medicines

Dr. Stefano Bonino of Durham University has just published an interesting and worrying article about the state of legal progress in the fight against poor quality medicine. The United Nations Office on Drugs and Crime (UNODC) has taken a significant interest in helping emerging nations work out how to combat the scourge of falsified and substandard medicines. UNODCs draft model laws were written by renowned expert (and contributor to this site), Professor Amir Attaran. I edited the draft at the request of UNODC, as did other experts. I was however, not invited to attend the session deliberating the draft held in Vienna from 9-11 July. It is fortunate that Dr. Bonino did attend, because UNODC is repeating a mistake made by another UN body, the World Health Organization (WHO).

The WHO is largely failing in its mission to combat poor quality medications because of the intransigence of influential member states such as India and, to a lesser extent, Brazil. As is well known to reviewers of our work on this site, India spends far more effort promoting its drug exports than in ensuring that the quality of those exports are fit for use. Any criticism of Indian drugs is assumed to be done at the behest of Western interests.

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UN Draft Law Against Medicine Crime is Fatally Flawed

ARTICLE ON THECONVERSATION.COM

A new legal template for fighting medicine crimes around the world is being developed by the United Nations. The first 39-page draft of the document was unveiled at a meeting in Vienna last month.

The aim of the proposed “
model law” is to address the dangers of medicines that have been criminally falsified, often because they contain no active ingredient, and substandard medicines that have been recklessly made because drug manufacturers have cheated or cut corners.

Counterfeit medicine, which counts as brand or trademark theft, was originally excluded from the proposal on the recommendation of Amir Attaran, law professor and lead consultant to the UN Office on Drugs and Crime (UNODC), because it is widely seen as coming under intellectual property law – a matter usually dealt with by the World Trade Organization. Unfortunately, UNODC came up with
different draft provisions that criminalise all sorts of medicine fraud, including counterfeiting trademarks.
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Designing a Global Coalition of Medicines Regulators

COUNCIL ON FOREIGN RELATIONS: POLICY INNOVATION MEMORANDUM

Globalization has transformed the marketplace for medicines in recent decades, giving rise to new threats including the poor traceability of global supply chains, counterfeit and substandard medicines, and antibacterial resistance. Aware that public drug authorities must cooperate to meet the emerging challenges of modern medicines regulation, the U.S. Food and Drug Administration (FDA) has been discussing with counterpart agencies abroad creating a "global coalition of regulators." Yet a coalition alone is not enough; the devil, as always, will be in the details. In pursuit of this goal, the FDA and partner medicines regulatory agencies should design a coalition with five distinct features:
narrow scope, to promote realistic goals; flexibility, to adapt to future circumstances; selective membership, to maximize like­-mindedness, particularly in the early stages;nongovernmental (NGO) participation, to leverage the capacities of both NGOs and for-profit corporations; and institutional partnerships, to orchestrate the activities of other regulatory organizations. Read More…
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