IPN Health Blog

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.

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.

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.

Fake Russian tamiflu comes as little surprise

As fears over swine flu peaked in the summer, search engine queries for "Tamiflu" soared by 1,400 per cent according to a report from software security firm Sophos.  The correlation is not hugely surprising, nor is the news that fake Tamiflu, thriving on this sudden internet-based interest, is being produced and transported from Russia.

In June 2008 the Russian Federation Council held a meeting entitled "The role of the state in the protection of the Russian market from counterfeit medicine."  A more honest meeting would have evaluated the role of the state in flooding the market with counterfeits in the first place.

Corruption and a complete disregard for the rule of law have been at the root of Russia's counterfeiting and 'grey market' pharmaceutical trades (for more info, see Making a Killing, page 21).

A company named Bryntsalov A produce up to 10 per cent of pharmaceuticals in Russia, yet this year they were found guilty of counterfeiting over 50 brands of medicine.  Remarkably, as reported on the excellent SecurePharmaChain blog, the punishment was little more than a "slap on the wrist", with token fines dished out of no more than $1,500.  By pure coincidence, two leading figures in the company are siblings Vladimir Bryntsalov and Tatyana Bryntsalova, the former being an ex-candidate for President (yes, of Russia). Both are said to have extremely strong political links.

It is therefore little wonder that only one victim company, Pfizer, had begun taking legal action according to the article (at IPN we've stressed the importance of civil law in deterring counterfeiters - in many countries, the rule of law is so weak, and political corruption so great that civil proceedings are simply not viable). In 2006 Pfizer surveyed the fakes market in Russia, finding an unusually high standard of counterfeit drug production (which is not, of course, to say that the drugs are good). All indicators point towards a very professional class of counterfeiters, in league with the political elite.

For these reasons, one must be extremely cynical when leading political figures (including Medvedev and Putin) pledge to "protect" their people from counterfeit drugs.  Rather than looking for political saviours we should be looking for political culprits, and ensuring they're accountable for their crimes.

Trading Away Access to Medicines?

Coinciding with another controversial seizure of medicines in the EU (Paris, this time) a group of NGOs have released a joint statement criticising EU trade policy.  Oxfam, HAI, and MSF have attacked the European Commission for its support of intellectual property (IP), which they claim “benefits…IP holders at the expense of Access to Medicines for millions of people, particularly in poor countries.”

The document is essentially an anti-IP polemic, in which the signatories rail against the alleged “deficiencies” of the patent system of “leaving a research gap” and neglecting diseases. We have argued against these claims in the past but they’re tangential to the enormous health threat that everyone else (Time magazine, Jacques Chirac, the WHO, UN head Ban Ki-moon, the Gates Foundation…) is talking about—the danger of drug resistant diseases, induced by counterfeit drugs.  Rather than conflating many issues and ideologically opposing all IP, health activists should take a more practical view on how IP laws can be shaped to help poor people in less developed countries (LDCs).

Access to medicines is an insufficient goal in global health. We should be aiming for access to high quality medicines. Substandard drugs (especially counterfeits) cause more harm than good, injuring patients and burdening poor countries and healthcare resources with new waves of drug-resistant disease.

When counterfeiters fake a product, they often fake a trademark too—it’s part of their deception, to leech off the good reputation of others. Stopping these fakes is one of the simplest means of protecting the poor from bad medicines and should be acceptable to opponents of other forms of IP. Even MEP Christian Engström of the Pirate Party agrees, stating last week: “The primary function of trademarks is to act as consumer protection ... The Pirate Party has no objections in principle to combating counterfeit goods or upholding the existing trademark laws.”

EU seizures of pharmaceutical goods in 2008 were almost entirely (93 per cent) for trademark infringement—ie. on suspicion of being fakes. Only 6 per cent were for patent infringement. By focusing on a minority of cases (for patent-infringement), groups like Oxfam, HAI and MSF are ignoring the main threat to patients in LDCs; and by conflating the issues and seemingly opposing all IP, they risk damaging measures that safeguard the poor from fake drugs.

Perhaps I’ve missed statements from these groups regarding the seizures of fake drugs (rather than generics), but given the severity of the situation they should be making more noise and making clear their views. Do they really think medicines with fake trademarks should be released into poor country markets? One hopes not. It’s time we stopped obfuscating this issue with squabbles over other areas of IP and found consensus in the fight against fakes.

Medicinas falsificadas matan 700.000 personas al año

Our fake medicine study has been translated into Spanish and is now available for download here.

We've also garnered some good international coverage, here and here.

Here's the press release:

Un nuevo informe del International Policy Network detalla el impresionante impacto de las medicinas falsificadas en los países menos desarrollados. Se estima que solamente las medicinas falsificadas para la malaria y la tuberculosis matan alrededor de 700.000 personas al año. Esto equivale a la caída de cuatro aviones tipo “jumbo” llenos de pasajeros  cada día.

El informe revela el creciente problema de las medicinas falsificadas y sub-stándar. Se estima que en Colombia el 5 por ciento del mercado es de medicinas falsificadas, mientras que las autoridades en la República Dominicana sospechan que el 10 por ciento de sus fármacos son falsificados. En el mercado Peruano se estima que las ventas de medicinas falsificadas ha crecido de $40 millones en 2002 hasta $66 millones en 2006. Estas medicinas falsas causan muertes innecesarias y mayores niveles de resistencia a los fármacos.

• En otras partes del mundo el problema es aún más severo. El informe establece que:
• Casi la mitad de las medicinas vendidas en Angola, Burundi y el Congo son sub-stándar,
• Aproximadamente las dos terceras partes de las medicinas contentivas de artesanato (anti-maláricas) en Laos, Myanmar, Camboya y Vietnam poseen cantidades insuficientes de ingredientes activos,
• La mayoría de las medicinas falsficadas provienen de la China y de la India.

Los esfuerzos para enfrentar el problema en base a regulaciones más severas y castigos a los criminales no combaten  la raíz de las falsificaciones. Peor aún, muchos países tienen sistemas legales y regulatorios corruptos, los cuáles son aprovechados por los falsificadores de tal forma que la aparición de nuevas reglas incrementa la corrupción.

Los gobiernos también excacerban el problema a través de tarifas e impuestos que hacen más costosas las medicinas genuinas.

El informe enfatiza la necesidad de establecer mecanismos efectivos para permitirle a los compradores de medicinas asegurarse de que lo que están comprando es genuino. Los sistemas de protección de identidad de origen mediante el uso de códigos verificables por un sencillo mensaje de texto ofrecen una posible solución. También pueden ser de utilidad  sistemas más efectivos de protección de patentes.

El autor del informe, Julian Harris, dice: “Muchos países pobres poseen leyes sobre patentes muy débiles, de manera que no es sorprendente que las falsificaciones abunden. Una prensa libre, tribunales autónomos y un libre intercambio comercial incrementarían la calidad de las medicinas”.

Combatting the spread of fake drugs in poor countries

This week we launched our new paper on counterfeit medicines, Keeping it Real, which highlights the shocking burden of fake drugs in less developed countries. Fake tuberculosis and malaria drugs alone are estimated to kill 700,000 people a year. That’s equivalent to four fully laden jumbo jets crashing every day.

The report lays bare the ballooning problem of counterfeit and substandard drugs, which can constitute one third of the drug supply in certain African countries. These dodgy drugs result in unnecessary death and increased levels of drug resistance.

The report highlights more shocking evidence, such as:

• Nearly half the drugs sold in Angola, Burundi, and the Congo are substandard
• About two thirds of artesunate (anti-malaria) drugs in Laos, Myanmar Cambodia and Vietnam contain insufficient active ingredient
• Most fake drugs originate from China and India

Current attempts to deal with the problem through tougher regulation and criminal penalties do not address the root causes of counterfeiting. Worse, many countries have corrupt regulatory and legal systems that are easily exploited by criminal counterfeiters, so additional rules will only increase corruption.

Governments also exacerbate the problem by making legitimate drugs more expensive through taxes and tariffs.

The report stresses that what is needed are effective mechanisms to enable purchasers of drugs to be assured that what they are buying is the real thing. Identity preservation systems using unique codes verifiable through a simple text message are one possible solution. More effective trademark systems would also help.

Report author Julian Harris said: “Many poor countries have weak or nonexistent trademark laws, so it’s no surprise that counterfeits are rife. A free press, free courts, and free trade would actually increase the quality of medicines.”

CLICK HERE FOR THE REPORT or find it at http://policynetwork.net/uploaded/pdf/keeping_it_real_2009.pdf

"Counterfeits are high quality drugs" says Indian press

The Indian media continues to maintain that measures to stop counterfeit drugs are really patent-enforcing conspiracies to thwart their generics industry.

Remarkably their claims have become even more blunt, with a supposedly-impartial news report stating:

"India believes that the difference is crucial as counterfeits are actually high quality drugs manufactured by producers other than the patent holder while a spurious drug is a low quality drug which may be harmful for health."

How utterly, utterly wrong. Even if they mean "counterfeit" in the sense of "violating a trademark", how can they or anyone be sure that such a drug is high quality? If a patient cannot be sure who produced the drug, as the trademark is faked, how can they have any confidence in its quality?

Patents are irrelevant to this debate. IMPACT, the body constantly opposed in the Indian media and by industry lobbyists and government representatives, states in its definition that issues of patent-infringement must NOT be confused with counterfeiting.

So why the endless lies, and beligerent reaction to anti-counterfeiting activities?

India should support measures that reward its manufacturers of high quality drugs while rightly hindering producers of fakes.

WHO getting closer on drug resistant malaria

The WHO issued a press release on Saturday, World Malaria Day, which at least showed they're starting to pay a little more attention to the role of counterfeit drugs in provoking drug resistance.

As we've mentioned before, counterfeits often contain too little active ingredient so that parasites survive and develop resistance to the drug.

The third paragraph of the press release states:

"Further jeopardizing ambitions to end the malaria threat ... is the wide availability of low-quality and counterfeit drugs in some countries of the Mekong region".

Absolutely correct, and exactly why the CFD has been highlighting the levels of drug resistance in the Mekong region, and the correlation with very high levels of counterfeit and substandard drugs.

The situation in the region isn't helped when taxes, tariffs and other duties block access to high quality drugs. The last comprehensive study of these levels found that Thailand's rates average out at 18.1 per cent, while Cambodia's stand at 13.5 per cent.

If governments persist in thwarting high quality drugs, substandard versions will continue to take their place.