[e-drug] Counterfeit medicines and WHO

E-DRUG: Counterfeit medicines and WHO
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Dear E-drug readers,

Contrary to recent media reports posted on e-drug MSF has not called on
countries to boycott a WHO meeting on counterfeit medicines. We believe
that counterfeit medicines which are medicines that are deliberately and
fraudulently mislabeled with respect to identity and/or source, are
dangerous for health and authorities need to take appropriate measures to
stop this criminal activity.

There is a clear role for the WHO to play in making sure that the
anti-counterfeit measures countries put in place are the right measures,
that they are effective and that they do not hamper access to and trade in
legitimate medicines. This will also require the WHO critically reviewing
what is being proposed in the context of IMPACT to ensure that no barriers
to legitimate medicines are put in place.

Some of you have drawn attention on this list to draft anti-counterfeit
legislation that would in fact negatively affect the availability of
generic medicines. We share those concerns and we believe that the WHO
should strongly warn against anti counterfeit measures that throw up
barriers to generic medicines. I refer to a briefing document we published
in response to the proposed anti-counterfeit legislation in Kenya.
Available at:
http://www.msfaccess.org/resources/key-publications/key-publication-detail/?tx_ttnews[tt_news]=1497&cHash=fa92956fc1 [repair link]

We also strongly believe that the WHO should step up its work on
substandard medicines and that this work should not be overshadowed by the
current emphasis counterfeit medicines. Substandard medicines are genuine
products which do
not meet quality specifications set for them. The problem of substandard
medicines is significant but it is distinct from counterfeit medicines and
requires a different set of interventions.

I refer to the recent paper on the issue of substandard medicines:
J.-M. Caudron, N. Ford, M. Henkens, C. Mace, R. Kiddell-Monroe and J.
Pinel, Substandard medicines in resource-poor settings: a problem that can
no longer be ignored. Tropical Medicine and International Health, volume 13
no 8 pp 1062-1072 August 2008.

available at:
http://www.msfaccess.org/fileadmin/user_upload/key-publication/Trop_Med_and_Int_Health_vol_13_Substandard%20Meds.pdf

It is also important to recognise that counterfeiting is only one
particular form of fraud related to the sales of pharmaceuticals. There are
others that may endanger health and that cannot be affectively dealt with
through anti-counterfeit measures. See for details:
http://en.wikipedia.org/wiki/Pharma_Fraud

Making sure that people have access to the treatment they need at a price
they can afford is of course the most significant action to take. If people
had systematic access to affordable, effective medicines of assured quality
counterfeiters and others engaging in fraudulent activities would have very
little space to operate.

Kind regards,

Ellen 't Hoen

E-DRUG: Counterfeit medicines and WHO (2)
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This message appeared in the Malawi Daily Times last Saturday.

It contains some outright untruths and misinterpretations mixed in with some undeniable facts, which is the usual style of this kind of writing. It is surely impossible for most newspaper readers to untangle an article like this, and to combat such messaging one needs plenty of time and background information to craft clear and unequivocal responses.

It's essential to address the quality of medicines - whoever produces them. And it's important that providers and national regulatory authorities continue to improve their quality assurance (Global Fund has just approved a much tighter policy). No-one would argue with this. But it is the false associations and parallels that are damaging to everyone's efforts towards this goal. For example, Norris strongly associates ARV drug resistance with implications about inadequate drug quality - this can indeed be a cause, but it is well established that there is a wide range of other factors also involved in development of resistance, relating to lack of ongoing access to medicines, treatment literacy, and social and economic factors. Mr Norris ignores science in order to make his points.

If Jeremiah Norris' (and others') biased and one-sided views are being read in national newspapers in countries most in need of affordable access to quality medicines, then that makes the job of extending access to treatment even harder - and it is already a huge challenge. Sowing seeds of doubt in the minds of the general public is one way to capture the market for branded medicines and reduce uptake of generic medicines, even when they are of excellent quality.

Very clever, Mr Norris - but reducing generic access doesn't actually lead to increasing access to branded/innovator medicines, because these just are not affordable for most people. Without healthy competition and lower-cost generics, few people with HIV in Africa would be on ART now, and millions would continue to die. As it is, many people are leading relatively healthy - and productive - lives because of access to low-cost ART.

Reducing generic access and market competition for ARVs means increasing the numbers of people who die from HIV. It's simple.

<clip> My Point of View -Quantity over quality weakens Aids treatment
BY Jeremiah Norris 17:45:08 - 28 November 2008
December 1 is World Aids Day, when health activists lobby their governments to spend ever larger sums and to achieve "universal" anti-retroviral treatment by 2010. This ambitious target will only be met if political considerations continue to trump science and to endanger HIV-Aids patients. The World Health Organisation (WHO) is the brains behind this "universal" supply of ARVs for 9.7 million HIV-Aids patients by 2010. It is based on the massive use of copy drugs from India, bringing the numbers of patients in poor countries on treatment up from virtually none in the early 2000s to 3.5 million today. While activists have applauded the speed of this "scale-up," it creates dangers. Many of the copies recommended by WHO are untested so patients cannot be certain that they act on the body in exactly the same way as the original (called bioequivalence). If the level of active ingredient is not absolutely correct, it can accelerate drug resistance and the mutation of the Aids virus. Under Indian law, drugs manufactured for export do not have to prove bioequivalence with the patented original. This is well-known to the authorities. WHO issued a Disclaimer, stating that its recommendation of a drug does not “constitute an endorsement or warranty of the fitness, by WHO of any product for a particular purpose, including in regard of its safety and/or efficacy in treating HIV/Aids.” But in real life the WHO’s list is followed by many poor countries that cannot carry out drug evaluation themselves. In 2004, WHO had to cease recommending 18 of the Indian ARVs on its list because of quality fears, although some were later reinstated.The Global Fund to Fight Aids, Tuberculosis and Malaria, the main funding body for Aids treatment, is equally lax about drug quality. Its "Option C" procurement guideline authorises drugs “not reviewed by a regulatory authority,” justifying this by lower prices and "political considerations" such as bolstering the fledgling African pharmaceutical industry. The Clinton Foundation serves as a procurement agency for the Global Fund and for UNITAID, a UN scheme which raises monies for Aids, TB and malaria via an airline tax. The Foundation claims its tests on the drugs it buys have not revealed any safety problems. But the Foundation is procuring a copy of the widely-used ARV Liponavir+Ritonavir (LPV/r) from an Indian firm. It has been submitted to the FDA for certification as a "true generic" but no approval has been forthcoming although the original is already approved. On September 29, the WHO released a price report on LPV/r in sub-Saharan Africa. The unit price for the non-approved drug was 50 US cents; the unit price for the approved drug was 36 cents. The WHO, the Global Fund and the Clinton Foundation therefore sanctioned a drug that was not only unapproved and potentially sub-standard but also more expensive. This is perverse in the extreme. The consequences of such Aids politics are starting to appear. In July, the director of infectious diseases at Belgium’s Saint Pierre University Hospital told the Financial Times of his shock after examining 100 Aids patients in the Democratic Republic of Congo: 30 of them had virus strains that resisted the standard medicines. “We are creating a virological time bomb,” he said. Brazil is often held up as the model for universal Aids treatment. It too has based this largely on cheap, untested copy drugs. In July, the government acknowledged that one third of the 190,000 Aids patients under treatment were in what it called “a more advanced stage”--but medical studies had already shown even higher levels of drug-resistance. The alarming Brazilian and Congolese drug-resistance statistics show what will happen under current policies. If donors reach the UN target of putting 9.7 million on Aids treatment by 2010, then 3.2 million would reach an “advanced stage of this disease,” needing drugs that are two or three times more expensive to buy and far more expensive to administer. Creaking African health systems will be put under intolerable pressure by millions of drug-resistant patients requiring expensive in-patient care. This growing mass of patients would soon need not only all the money currently spent on Aids but the total of present foreign aid too. WHO and its partners have focused on the politically-correct quick-win without regard to the consequences. The Global Fund's donors and WHO member states must demand a stop to practices that threaten entire health programmes and patients' lives.
==The author is director of the Centre for Science in Public Policy, Hudson Institute, Washington DC<end of clip>

Carolyn Green
Independent consultant - health & development
cgreenconsult@hotmail.com
skype: cgreenconsulttel: +44 1273 738 998
cell: +44 77311 2368

E-DRUG: Counterfeit medicines and WHO (3)
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Thanks for this - I missed it in the papers. It possibly also followed on
from the Pharmacy Awareness Week held recently, where the theme was to
reject illegal drugs eg. those sold through vendors on the local
markets. The Pharmacy Medicines and Poisons Board together with the
Pharmaceutical Society of Malawi mounted this through street parades,
music, drama etc in the major towns across Malawi.

I shall set the topic as an essay for some of our students in the coming
academic year. We have laboratory based projects to look at substandard
medicines, sampled from a range of outlets across southern Malawi, as part
of our final year degree programme. Pharmacovigilance may reveal other
problems related to such supplies, something we hope to get under way this
year too. If anyone has bright ideas as to how to pursue either of these
aims in a resource poor environment, 80% rural population with rapid
urbanisation, a limited control by an overworked inspectorate (one full
time Inspector!) then let me know.

Thanks.

mberry@medcol.mw.
Acting HOD, Dept. of Pharmacy,
College of Medicine,
University of Malawy,
P/Bag 360 , Blantyre