The Sharp Tip of the Lancet

  • by: |
  • 02/27/2012

According to the World Health Organization, “Counterfeit drugs may erode public confidence in health care systems, health care professionals, the suppliers and sellers of genuine drugs, the pharmaceutical industry and national Drug Regulatory Authorities.” And, in an editorial, the editors of the Lancet ask, “So what should be done to tackle the growing problem of counterfeit medicines?”

The Lancet makes a strong and straightforward case for action. “The consequences of counterfeit drugs are diverse, as are the solutions, which lie in collective involvement, responsibility, and responses of all interested parties: health professionals, drug regulatory authorities, judicial entities, and drug companies at both national and international levels. Critical to this effort is strengthening of drug regulatory authorities, which should not only be responsible for improving drug standards, but also provide effective recognition of counterfeit drugs and assist other agencies in stopping their trade. This is especially needed in those countries that have either no drug regulation at all or an impaired or corrupted system. Additionally, enactment and enforcement of new laws for prohibiting counterfeit drugs is vital.”

And the editors ask the obvious and troubling question, “So why is there not yet an international fake drug treaty?”

We all know the answer.

The Lancet tells the often uncomfortable and undiplomatic truth that “the Indian and Brazilian Governments and some non-governmental organisations … believe it would confuse quality and intellectual property rights issues and thus undermine access to legitimate and much lower-cost generic medicines consumed mostly in poor areas.”

As Prashant Reddy opined in Spicy IP, “Every time an intellectual property issue is brought up by an international organization in the context of public health we presume that there is an 'imperialist/blood thirsty East India type corporation' conspiring against India. The level of paranoia is simply unbelievable. It is time India started acting like a responsible, confident nation before it decides to torpedo international negotiations. It would also be nice if the Government could start articulating its concerns in the language of public health and not in the language of the generic drug industry.”


It’s time to actively and aggressively pursue FDA Commissioner Peggy Hamburg’s call for a regulatory Marshall Plan to help build, nation-by-nation, global systems for both quality and safety.

Working together to raise the regulatory performance of all nations will help all nations create sound foundations to address a multitude of quality and safety dilemmas such the manufacturing of biosimilars, the control of API and excipient quality, pharmacovigilance and, yes, even counterfeiting.

And here’s the sharp tip of the Lancet, “The fight against counterfeit drugs must be strengthened without further delay. It needs consensus among all countries and interested parties, and requires wise and bold leadership from WHO. An indispensable goal of the campaign is ensuring the availability of genuine and affordable essential medicines in developing countries.”

Memo to New Delhi and Brasilia – get with the program … or get out of the way.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

Blog Roll

Alliance for Patient Access Alternative Health Practice
Better Health
Biotech Blog
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
Envisioning 2.0
FDA Law Blog
Fierce Pharma
Fresh Air Fund
Furious Seasons
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
In the Pipeline
In Vivo
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
More than Medicine
National Review
Neuroethics & Law
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmacology Corner
Pharmaceutical Business Review
Piper Report
Prescription for a Cure
Public Plan Facts
Real Clear Politics
Shark Report
Shearlings Got Plowed
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog