IPN Health Blog

Drug inspector reveals state corruption in Pakistan

A drug inspector in Pakistan has spilled the beans on corruption within the state department which is fuelling the trade in fake medicines.

IPN has long argued that state corruption and weak rule of law are leading factors in the dissemination of fakes.

The inspector revealed that cases often sit in the courts for up to a decade, while the criminals keep operating, or simply move elsewhere to escape conviction.

"Vested interests" in the government are blamed for deliberately stifling justice.

"Due to the vested interests of a few notorious people at the QCB [Quality Control Board], these cases are still pending and have been put off for special meetings — which may or may not take place,” added a police official in Karachi.

Meanwhile the inspector said: “Piles of cases have been filed in the Sindh Drugs Court, but all of it seems in vain as the court is busy dealing with cases that had been registered nine or 10 years ago”.

Another senior official at the department revealed that honest inspectors have been moved away from their work with no justification, policies which "highlighted that corruption that is rampant in the department”.

“The department has become a den for money makers and criminals, where good performances at work can be brought against you,” he said.

Read the full story here.

Protecting IP rights DOES protect against counterfeiting

New anti-counterfeiting laws may not be a silver bullet against dangerous fake products, but Sisule Musungu is wrong to claim that IP protection cannot affect the quality of goods—and way off the mark in his conspiracy theories about IP being a sinister trade tool of “the West”.

Thankfully he differentiates between different forms of IP in the interview (patents, copyright, trademarks) and it’s important that laws do the same. Further, new laws are no use if they’re not implemented fairly and efficiently. Head of the Nigerian food and drug regulator Paul Orhii recently explained: “[Counterfeiting] criminals, who are usually very wealthy, very often go scot-free in court … in Nigeria the litigation process is very sluggish. Some cases last for more than 10 years in one court…”

Without a strong rule of law, new laws are pointless.

However, trademark protection plays a considerable role in improving the quality of products and protecting patients against fakes.  While a trademark itself doesn’t involve quality testing, it identifies the producer to patients and authorities—allowing both to take legal action if the product is harmful. It is no coincidence that counterfeiting and substandard products are rife in parts of the world where trademarks cannot be protected.

Sisule Musungu says that “a trademark only tells you about the reputation of the company”, without acknowledging that such a reputation will likely rely on quality more than anything else.

Trademarks are a unique kind of intellectual property, in that they do not just protect the producers and their innovation: they also help patients choose products that they trust, while poor quality products attract a bad reputation and are shunned. Patients can be tricked into buying bad products when trademarks are faked but, if trademarks and individuals' rights are protected, counterfeiters are taken to civil or criminal court and punished, deterring the crime.

History suggests that the quality of goods (such as medicine and food products) increases precisely when trademarks can be enforced, and brands are allowed to compete amid a competitive market. In nineteenth-century Britain, food contamination was a common problem, especially due to copper usage in the production of certain goods. As a consequence, some companies gave up ‘coppering’ – such as Crosse & Blackwell, the producers of pickles. Initially their sales fell, yet soon people realised the safety benefits, and the company went on to become the trusted, successful brand it still is today. Trademarks, competing on quality, raised the safety standards in an open market.

Trademarks are not the preserve of ‘Big Pharma’, or large Western corporations. They are equally important in allowing generic producers and small companies to signal to customers that their products are of high quality, and protecting their reputations (and the health of patients) from counterfeiters. To rubbish this proven system is extremely unwise, given the problems suffered in less developed countries with fake medicines.

Sealing the deal on fakes in Nigeria

Drug manufacturers should disregard profit and instil security seals on products to help patients identify fakes--this is the message from head of Nigeria's Onitsha Patent and Proprietary Medicine Dealers Union, ahead of a meeting on the topic.

His comments, while well-intentioned, are misguided on two counts.

Firstly, security tags are no guarantee against counterfeiting. Rather, they simply get counterfeited themselves.

In Kenya counterfeiters have even invented fake security tags. This story was reported just a few weeks ago.  It's for this reason that companies are turning to serialisation systems which are far more difficult to fake.

Secondly, he ignores a primary advantage in the fight against fake medicines--far from being a problem of self-interest, everyone's (apart from the counterfeiters') self interest points in the same direction. Manufacturers want to protect their profits by protecting their brands against fakers. Patients want to be confident about buying genuine products from those high quality manufacturers. Working against counterfeiters suits them both, while fake medicines harm profits and health. There are none of the "negative externalities" that critics of markets love to allege.

Even if a product is identified as fake, further problems can then be encountered. In Nigeria, according to the head of the regulator NAFDAC, cases against culprits are thwarted due to the "very, very sluggish" legal system. Some cases last over 10 years, he said recently.

Security seals, without serialisation, probably won't work. And even if they do, it's little use if legal action cannot be quickly and efficiently taken against the culprits in court.

GOTCHA!

More developments in the Argentinian fake medicines scandal which, in case you haven't been reading, has been linked to key supporters of the President.

Already arrested are the head of a trade union (and, oddly, his girlfriend) and head of a pharmaceutical company. And four others.

Now reports suggest officials in the Ministry of Health are implicated and that more arrests will follow.

Where fake drugs exist, corruption is typically not far behind. This serves as yet another example of why the problem cannot be solved by increasing the power of politicians and government officials. They're often the ones driving the fakes in the first place.

GOTCHA! Update: the under-secretary of Health, Buenos Aires, has turned himself in. Click here for the report.

Bad science and fire-darkened kitchen utensils

Indian industry website Pharmabiz today reports that "health ministry sources" are accusing IPN of "unscientifically" constructing reports on fake medicines--while promoting a new government survey that claims just 0.04% of Indian drugs are fakes.

Let us examine the accusations, whoever they come from:

The principal objection is to a single figure referred to in our paper Keeping it Real, derived from the Associated Chambers of Commerce and Industry of India and stating that the fake drug market is growing by 20–25 per cent per annum.

The claim is that this is an unreliable figure, used to falsely portray fake drugs as a problem for India, while new government data shows it's a negligible problem.

So where to start?

Well firstly, our paper correctly names the source and provides full citations for this stat. But more importantly no claim rests on the figure alone. The paper provides other examples of fake Indian drugs being discovered--such as EU Customs figures and Indian surveys.

And it could have listed much more. For example, a 2008 study in six major African cities found that 31% of drugs listed as being from India were substandard. A subsequent study of drugs bought from shop-front pharmacies in New Delhi and Chennai found 12% of drugs were substandard.

And here are some recent headlines from the Indian press:

• Indian Express, 1st December: "Fake drugs are sold rampantly"
• Times of India, 14th November: Cops identify fake drugs "kingpin"
• Times of India, 13th November: Cops smell fake drug racket
• ExpressBuzz, 10th November: Sri Lanka bans four Indian drug companies for supplying sub-standard and adulterated drugs
• Economic Times, 20th October: Criminal proceedings against Hyderabad pharma company

And so on.

Media headlines may not provide scientific proof, but the New Delhi and Chennai study, peer-reviewed in a respected journal, certainly does. And it shows that some people involved in the Indian supply chain provide very high levels of substandard drugs--indicating deliberate foul play and the spread of counterfeit medicines. In two pharmacies, for example, over 1 in 4 drugs sold was seriously substandard--some of them containing zero active ingredients.

The government statistics which Pharmabiz cites, however, are less robust. Rather than releasing the data, the headline findings were leaked in September to ... that's right, Pharmabiz.  Almost three months later the same headlines appeared in Mint.  The headlines claim, somewhat remarkably, that out of 24,000 sampled drugs, only ten were fake (or 'spurious'). It's unclear how authorities continue to find fake drugs, as reported in the media week in week out, if only 0.04% of the market is fake.

There are, however, grounds for suspicion. Strangely, the medicines procurred in the government's survey were simply handed over to manufacturers--with only those who responded saying the products were counterfeited being counted as 'spurious'. The samples were then collected back, and tested for quality.

As unusual as this methodology is, a notable omission from the Pharmabiz article is what proportion of the drugs were then found to be substandard.  Previous Indian state surveys, while finding very low levels of 'spurious' drugs (often without defining 'spurious') have found substandard drug levels ranging between 8.19% to 10.64% over several years. And some areas, such as Haryana state, recorded substandard levels of over 40% (!)

The peer-reviewed survey referred to above shows that the clear majority of Indian pharmaceuticals are of high quality, and many suppliers are honest and well-intentioned. But clearly a minority are getting away with pushing at best substandard, and at worst blatantly fake drugs.

If the government has useful data on this subject then the methodology and data should be made public. Burying heads in the sand by leaking sensationalist headlines to industry websites is the real "unscientific" practice here, and helps neither patients nor the industry itself.

"Envy of the world" shown up again

Britain's state-run National Health Service (NHS) doesn't fare too well in comparisons of cancer survival rates.  Every year studies show far more deaths under the NHS's watch than in countries of comparable wealth.  "20% higher than Europe" reported a recent headline, while new cancer drugs continue to be rationed, often considered "not cost effective".

Now it's the turn of survival rates within the UK to throw up some shocking results, and destroy a few fallacies in the process.  The Guardian reports that your likelihood of beating cancer differs hugely depending on where in Britain you live.  People in plush Kensington & Chelsea, lo and behold, are three times more likely to survive a year than folk out in Herefordshire.

So back to those fallacies - firstly, there is no such thing as "healthcare" as a set, unvariable service. Just like food, cars, shoes et cetera, healthcare standards are completely variable - and new innovations constantly provide standards that people could not have dreamed of in the past. Like the aforementioned products, higher standards will come with higher costs, and therefore higher prices.

Secondly, these variations cannot be ironed out by government-provided services. We simply end up with varying services and less choice between them. Typically it's the poor who lose out, just as children in deprived inner-city areas are obliged to attend worse state schools than children in leafy home counties with a comfortable local comp in the village. The "postcode lottery", often not a lottery at all, affects both these state monoliths.

Ukraine government provoking rise in fake medicines?

The Ukraine government has hyped up the threat of swine flu, causing panic-driven demand for medicines, claims an intriguing blog post on UkraineWatch.

According to the piece, the government subsequently:

• Caused stock-outs through scaremongering, as demand skyrocketed
• Imposed price controls
• Threatened to arrest anyone "profiteering" from the swine flu panic

As a result of the latter two policies, supply of medicines plummeted. So having boosted demand, they then quashed supply.

Smart, eh?

The article says this caused people to turn to traditional remedies (boosting their prices, too), yet an equally likely side-effect would be an increase in fake medicines.

And this month we've already had news of high levels of fakes in Ukraine - such as in this excellent report on SecuringPharma.

Reliable figures, they state, are not readily available to reveal how many fakes operate in the Ukraine market. But with neighbouring Russia's leading industry in fake Tamiflu, I bet there's a steady supply plaguing the market.

If this is the case, hopefully people will remember the policymakers who kicked it off in the first place.

Salt and Shake Spin

“UK experts” warn that the government target for cutting the salt you put on a baked potato isn’t strict enough.

That’s according to the BBC, whose coverage gives the impression the only dispute among our benign dietary overlords is between whether they should terrify us into near total salt avoidance, or just plain scare us into a slightly less tasty diet.

But there’s plenty of evidence that the whole statist plan to regulate the nation’s scrambled eggs needs to be taken with, well, a pinch of salt. When new anti-salt ads were unveiled in October, The Times quoted Catherine Collins, chief dietician at St George’s Hospital in London: “Advice to cut back on salt really is the poorest of all the dietary messages around.”

So who are the “experts” recommending that the government’s action against pork scratchings must go futher? As so often in these cases, fakecharities.org can help. Here we find that "Consensus Action on Salt and Health" receives substantial donations from the Food Standards Agency, the government agency it is supposedly lobbying for more regulation. Somehow the BBC fails to mention this.

Perhaps we need  a new study into whether state-funded charities and state-funded news websites might just have a bias towards deeper state involvement in our choice of crisps.

Marc Sidwell

Innovation versus Rationing

The latest headline-filling case of NHS rationing emerges today, with news that another new cancer drug will be unavailable to patients in the United Kingdom.

This time it's Nexavar, which can extend life for up to 6 months for people with liver cancer.

The announcement comes just weeks after the last of a long string of studies to show up the UK's quite abysmal cancer survival rates.  The UK's largely government-owned, -funded and -run health service constantly falls behind other systems which utilise private providers and offer a greater variety of choice.

Meanwhile, on a more optimistic note, the Cato Institute have released an interesting paper on Why America Leads the World in Medical Innovation.  Definitely worth a peruse.

Unless, of course, your cancer is being 'treated' by the UK's state monopoly, in which case such innovative drugs will be considered "not cost effective" enough to keep you breathing.

Seizures confusion drags on

If there's one thing we don't need in the fight against fake drugs, it's more confusion and misinformation. Yet the issue of the day--the EU's seizures of Indian medicines in transit--is being warped by mix-ups over the most basic of facts.

An article in the Business Standard today claims rather sensationally that:

"All the consignments detained so far have eventually been found to be of genuine, off-patent generic drugs on their way to countries where these are not patented."

And therefore, they argue, "there is no evidence" that seizures are defending patients against counterfeit drugs or even genuine intellectual property rights violations.

All the consignments, they say? All medicine consignments seized by EU authorities?

This seems in direct contradiction to EU Taxation and Customs documents, the last of which (published in July 2009) reported that there were 3,207 seizures in 2008, 93 per cent of which were on suspected trademark breaches.  Only a minority (6 per cent) were for patent infringement.

EU seizures of medicines increased by 57 per cent on the previous year (2007) following the launch of the MEDI-FAKE action.

This drive saw over 34 million illegal pills seized. The EU details cases of mass seizures of counterfeit medicines, such as 600,000 counterfeit antimalarials that were seized in Brussels (presumably on their way to Africa).

We know that fake medicines are entering and passing through European countries. Even in the UK authorities have reported increased amounts of counterfeit medicines being imported in recent months.

If this crucial context is ignored, and the facts obfuscated, there will never be a solution delivering free trade rights and access to high quality medicines.