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The direction the WHO MSM is taking means it is unlikely to combat any of the most widespread problems with substandard medicine.

Posted by Roger Bate My op-ed with Dinesh Thakur in The Hill today highlights the recent recommendation by Europe's chief drug regulator to suspend generic drugs whose approvals were based on flawed — or forged — clinical studies conducted by GVK Bio, an Indian contract research organization.

We urge U. Posted by Roger Bate A new research paper in Health Affairs suggests that the use of compulsory licenses may not lead to cost savings, when compared with voluntary negotiations.

Compulsory licensing CL allows low-income countries to break innovator patents and accelerate cheap alternatives, either produced locally or imported.

But researchers including Amir Attaran a contributor to this site at Universities of Ottawa and Denver demonstrate that negotiations of companies with foreign governments and multilateral and bilateral donors was more efficient at lowering prices.

The paper does not analyze the quality of the drugs actually procured, but it is instructive that in only 2 of 13 cases where CL was used for local production was the price cheaper than would have been delivered by negotiation.

And some of the companies, notably in Indonesia and Equador that produced as a result of CL have dubious quality records, according to local experts I spoke with.

Of course, CL remains a legitimate tactic for emerging nations when companies remain intransigent in tiering their prices for lower incomes, but it should always be a last result.

The price of drugs will probably be worse, and the quality less likely to be good either. Posted by Roger Bate Cairo, Egypt — While its economy is still suffering from weak tourism, its new government is trying to do its best to bolster its modest regulatory structures to oversee medicines.

The fake of the cancer drug Avastin that hit America in probably transited Cairo, and trade in fakes of all sorts of medicines is an ever present threat to health.

Only Jordan and Israel in the region do a better job of overseeing the medicines on the market. But the worrying thing for the Egyptian Drug Authority is that as a transit point it has a lot of unregistered drugs entering the market.

Unregistered drugs may work fine, but our evidence shows they not as well made and are 5 times more likely to be substandard as registered products.

And here the drug regulator cannot do it alone. As the EDA Vice Minister, Dr Tarek Salman, is well aware the Ministry of Health needs the assistance of other agencies, such as customs, police and health authorities, in order to intercept such potentially dangerous products.

A Task Force to achieve this end is being planned. Working out the details will probably take time, but at least Egypt has identified a problem and is going to try to resolve it, which puts it far ahead of most nations, including many developing ones.

Is India right on its processes but wrong on its drug quality? In our National Bureau of Economic Research working paper on the quality of Indian medicines exported to Africa we concluded that poorer quality products were intentionally being sent to Africa because of the continents generally weak oversight of drug quality.

Litigation is rarely an effective method of finding the truth, more often a process to limit investigations and hide the truth, especially when those threatening have problems with jurisdiction, standing and no case at all.

But the obvious indignation of many well-educated Indians made me think that there could well be folks within the Indian government and even Indian industry that have absolutely no idea of the problems its Industry has.

Assuming the data we presented in our NBER paper are accurate, is there a possible explanation for the bold-faced denial of leading Indian commentators?

One possibility is that Indian companies actually do largely follow good practices, but still make some even many bad products.

Suppose a company follows decent pharmaceutical practices in formulating medicines, one could still make an inferior medicine if the ingredients were incorrect in some way.

In such a way inferior, incorrect or generally sub-par ingredients could be used in otherwise correct formulations. In fact your regular supplier may not have changed its practices either, but the practices of another intermediary they buy from may have changed.

The world of pharmaceutical chemical supply is convoluted and largely ignored by drug regulators. Even when it is exposed as incorrect many customs agents have neither the incentive nor the ability to follow up.

If a criminal act has been exposed, or trade in a dangerous immediately toxic or explosive product, has been exposed then customs agents in most parts of the world will act.

But many ingredients for drugs are inert and never immediately dangerous, and paperwork irregularities for such products are a low priority for customs agents.

My research in Asia and the Middle East over the past decade culminated in several papers and books documenting some of the flaws in the intermediary stage see most recently this article with links.

Ignoring flagrant criminal action such as cargo theft, most problems for drug quality come from inaccurate paperwork, sometimes flagrant fraud.

For example I saw a bill of lading indicating that chemicals had originated in Italy, when they had been processed somewhere in China. Italy remains one of the largest producers of active pharmaceutical ingredients in the world.

If Chinese production is of Italian quality then there will be no problem, but if the ingredients were inferior in some way, and an Indian firm is buying what appears to be good value Italian chemicals that are no such thing, then correct production could take place in India, but an inferior medicine being produced.

At that stage, assuming testing is undertaken the problem may be unearthed, but it may not. Perhaps the product is entirely fine in good storage conditions but is unstable at higher temperatures or humidity — conditions that may exist in Africa.

In such a way inferior products may end up being consumed in Africa with few errors from the Indian producer, and certainly no intent to export inferior products.

Investigating deeper into the middle of drug supply chains is not straightforward, but it may be vital if we are to root out substandard medicines.

Companies have to secure up those parts of the chain that others cannot follow easily. This so-called campaign is actually an academic study which identifies uncomfortable data that some Indian companies, or their distributors, seem to be sending inferior medicines to Africa see below for a point by point response to their unfair allegations.

The reaction by Indian industry is disgust, dismay and anger, and absolutely no self-reflection. This is why some of the data may appear old.

It was only when enough data had been collected did the authors of this paper start to notice the problem with Indian exports to Africa — no original study targeted Indian medicines.

Most never bothered to reply, and those that did refused to provide any information since we were not regulators or trading partners.

NBER is one of the most respected research associations in the world. To be able to post a working paper requires one to be a member.

Indian companies may be unaware that it is typical within the economic literature for working papers to be posted and then for peer review to take place.

This is a process the same authors have followed before. All previous working papers have resulted in peer review publications and while the contents change in subtle ways due to review, the conclusions have remained consistent.

The paper published by the National bureau of Economic Research and not AEI as claimed by the Economic Times see here , shows that Indian firms send their worst quality medicines to Africa.

For example, he asks why did it take so long to publish a study with data going back to ? Many of the data were collected and published in previous papers on drug quality see the papers on this site , what this new paper does is pull together all the data on drugs made by Indian firms over the past five years.

It is still too soon to see whether the new Modi Government addresses quality concerns, but assuming it also does not, then the result will be more problems with Indian products and ultimately more patient suffering.

Posted by Roger Bate A Star Newspaper investigation of drug quality in Canada see here demonstrates the risks patients in rich nations like Canada run from receiving poor quality medicines, especially imported from India.

What is most worrying is the lack of transparency at some western health agencies. What the investigation shows is that Health Canada has hidden information about problems with medications.

While it is true that educated people occasionally make bad medicine choices think of celebrity boycotts of vital vaccinations , on the whole educated people deserve to be informed about the risks they face.

Unregistered drugs may work fine, but our evidence shows they not as well made and are 5 times more likely to be substandard as registered products.

And here the drug regulator cannot do it alone. As the EDA Vice Minister, Dr Tarek Salman, is well aware the Ministry of Health needs the assistance of other agencies, such as customs, police and health authorities, in order to intercept such potentially dangerous products.

A Task Force to achieve this end is being planned. Working out the details will probably take time, but at least Egypt has identified a problem and is going to try to resolve it, which puts it far ahead of most nations, including many developing ones.

Is India right on its processes but wrong on its drug quality? In our National Bureau of Economic Research working paper on the quality of Indian medicines exported to Africa we concluded that poorer quality products were intentionally being sent to Africa because of the continents generally weak oversight of drug quality.

Litigation is rarely an effective method of finding the truth, more often a process to limit investigations and hide the truth, especially when those threatening have problems with jurisdiction, standing and no case at all.

But the obvious indignation of many well-educated Indians made me think that there could well be folks within the Indian government and even Indian industry that have absolutely no idea of the problems its Industry has.

Assuming the data we presented in our NBER paper are accurate, is there a possible explanation for the bold-faced denial of leading Indian commentators?

One possibility is that Indian companies actually do largely follow good practices, but still make some even many bad products.

Suppose a company follows decent pharmaceutical practices in formulating medicines, one could still make an inferior medicine if the ingredients were incorrect in some way.

In such a way inferior, incorrect or generally sub-par ingredients could be used in otherwise correct formulations.

In fact your regular supplier may not have changed its practices either, but the practices of another intermediary they buy from may have changed.

The world of pharmaceutical chemical supply is convoluted and largely ignored by drug regulators. Even when it is exposed as incorrect many customs agents have neither the incentive nor the ability to follow up.

If a criminal act has been exposed, or trade in a dangerous immediately toxic or explosive product, has been exposed then customs agents in most parts of the world will act.

But many ingredients for drugs are inert and never immediately dangerous, and paperwork irregularities for such products are a low priority for customs agents.

My research in Asia and the Middle East over the past decade culminated in several papers and books documenting some of the flaws in the intermediary stage see most recently this article with links.

Ignoring flagrant criminal action such as cargo theft, most problems for drug quality come from inaccurate paperwork, sometimes flagrant fraud.

For example I saw a bill of lading indicating that chemicals had originated in Italy, when they had been processed somewhere in China.

Italy remains one of the largest producers of active pharmaceutical ingredients in the world. If Chinese production is of Italian quality then there will be no problem, but if the ingredients were inferior in some way, and an Indian firm is buying what appears to be good value Italian chemicals that are no such thing, then correct production could take place in India, but an inferior medicine being produced.

At that stage, assuming testing is undertaken the problem may be unearthed, but it may not. Perhaps the product is entirely fine in good storage conditions but is unstable at higher temperatures or humidity — conditions that may exist in Africa.

In such a way inferior products may end up being consumed in Africa with few errors from the Indian producer, and certainly no intent to export inferior products.

Investigating deeper into the middle of drug supply chains is not straightforward, but it may be vital if we are to root out substandard medicines.

Companies have to secure up those parts of the chain that others cannot follow easily. This so-called campaign is actually an academic study which identifies uncomfortable data that some Indian companies, or their distributors, seem to be sending inferior medicines to Africa see below for a point by point response to their unfair allegations.

The reaction by Indian industry is disgust, dismay and anger, and absolutely no self-reflection. This is why some of the data may appear old.

It was only when enough data had been collected did the authors of this paper start to notice the problem with Indian exports to Africa — no original study targeted Indian medicines.

Most never bothered to reply, and those that did refused to provide any information since we were not regulators or trading partners.

NBER is one of the most respected research associations in the world. To be able to post a working paper requires one to be a member.

Indian companies may be unaware that it is typical within the economic literature for working papers to be posted and then for peer review to take place.

This is a process the same authors have followed before. All previous working papers have resulted in peer review publications and while the contents change in subtle ways due to review, the conclusions have remained consistent.

The paper published by the National bureau of Economic Research and not AEI as claimed by the Economic Times see here , shows that Indian firms send their worst quality medicines to Africa.

For example, he asks why did it take so long to publish a study with data going back to ? Many of the data were collected and published in previous papers on drug quality see the papers on this site , what this new paper does is pull together all the data on drugs made by Indian firms over the past five years.

It is still too soon to see whether the new Modi Government addresses quality concerns, but assuming it also does not, then the result will be more problems with Indian products and ultimately more patient suffering.

Posted by Roger Bate A Star Newspaper investigation of drug quality in Canada see here demonstrates the risks patients in rich nations like Canada run from receiving poor quality medicines, especially imported from India.

What is most worrying is the lack of transparency at some western health agencies. What the investigation shows is that Health Canada has hidden information about problems with medications.

While it is true that educated people occasionally make bad medicine choices think of celebrity boycotts of vital vaccinations , on the whole educated people deserve to be informed about the risks they face.

They will make decisions accordingly. Health Canada, and all other health agencies, should treat us as grown-ups and give us ALL the facts.

Posted by Reed Beall and Amir Attaran respectively Phd Candidate and Professor, University of Ottawa On September 8, we posted a blogspot about our recent article published in Health Law in Canada , in which we write that Canada is providing haven for internet pharmacies located on Canadian soil that advertise and sell unapproved medicines illegally.

We called this a transnational transnational organized crime, which Canadian officials are knowingly facilitating. We offered examples of our government both of us live in Canada of turning a blind eye, even in a case where a Manitoba-based pharmacy and its affiliated companies trafficked fake, indeed poisonous, cancer medicines to Americans.

More to the point, we promised readers that we would offer updates on the complaint letter that we sent to Health Canada and other regulators on July 3, , in which we alleged three bricks-and-mortar, licensed pharmacies in British Columbia and Manitoba are involved in illegally advertising and selling unapproved medicines over the internet.

As of our last blogspot on September 8, Health Canada had not even acknowledged our complaint. What a difference a day and a pointedly-worded blog makes!

Lo and behold, the next morning at AM, Health Canada wrote us the acknowledgement we were waiting for. Here is their response —and it contains a shocking admission.

Simply put, Health Canada admits that it does not intend to enforce the law on Canadian internet pharmacies that sell to foreigners. Incidents that present a potentially higher risk to health will be actioned first.

Incidents of low or nominal risk will be assessed and entered into our tracking system for possible future compliance action as deemed appropriate.

But if the health risk is to Americans, Europeans or anyone else, Health Canada does not even bother to assess and track those cases, much less act on them.

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