Cambodian Inspectors examine suspected medicine in a crowded market along Thai-Cambodian border during an inspection July 23, 2010 in Pailin province, Cambodia. Photo: Getty Images
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Unregulated fake medicines are threatening the fight against diseases like malaria

There is currently no international law or body that can organise the detection and prevention of fake medicines - and it's a critical threat to our ability to fight deadly diseases.

In the UK, when horsemeat – which is not life threatening – turned up in a supermarket burgers that claimed to be made of beef, it was a national scandal. Imagine that a similar situation emerged, but this time instead of beef products, it was life-saving medicine that contained unlabeled, unsafe ingredients. You’d rightly expect the full weight of the law to come down on the manufacturers. And in the UK, that would likely be the case. You might be surprised, then, to find out that there is in fact no international law to prevent the trade in falsified medicines, and in many parts of the world without similar regulatory systems in place, these ‘medicines’ – packets labeled as a drug, but in fact containing none of the active ingredients - are big business.

In June 2012 a shipment of loudspeakers arrived in a container in the Luanda docks having travelled by sea from Guangzhou to Angola. Nothing unusual in that, given the burgeoning trade between China and Africa. However, all was not what it seemed.

Within the loudspeakers were 1.4 million packets of falsified medicine, mostly labeled as a key life-saving antimalarial drug: artemether-lumefantrine. Detailed analysis by scientists confirmed that the packets contained no active drug and would have had no beneficial affect for malaria – no more than listening to music through the loudspeakers.

There were also packets that claimed to contain the deworming medicine mebendazole. Not only did they not contain any of the active ingredient stated on the label, they did contain a drug called levamisole, a deworming medicine that has been withdrawn from human use in many countries due to severe side effects, including bone marrow failure. There has recently been an epidemic of severe blood vessel inflammation resulting from ‘cutting’ cocaine with levamisole, suggesting links between criminals producing cocaine and these falsified medicines.

Had the falsified malaria tablets got into the supply chain they would inevitability have increased death and sickness. Worse still, they could increase malaria parasites’ resistance to the real drugs which save millions of lives in sub Saharan Africa each year.

On their own, falsified medicines, containing no antimalarial, will not risk antimalarial resistance, as there is no drug in the patients’ blood for any resistant parasites to survive attack from and multiply. However, in the many countries with inadequate regulation of medicine both falsified medicines and substandard medicines commonly occur together. Substandard medicines result from errors in production and not fraud, and usually contain less than the stated amount of antimalarial compound. If patients develop very high concentrations of parasites in their blood through taking falsified antimalarials that have no effect, and then take substandard medicines, susceptible parasites in the blood are killed but the resistant ones multiply – and are sucked up by mosquitos to spread to the next unwitting patient.

This risks catastrophe for the spread of resistance to these front line drugs. If resistant parasites spread to Africa, as has already happened across Southeast Asia, the death toll will be enormous: potentially millions of lives and billions of dollars.

Over the last few decades there has been much high level debate about malaria, given the toll on lives, livelihoods and societies. The scandal is that there has been remarkably little action to ensure the quality of antimalarials. It is not regarded as a sexy subject in international public health and seems to be viewed as intractable. It is not intractable. The seizure in Angola illustrates some of the major problems in improving the global medicine supply but, as I and others have outlined in Lancet Global Health this week, there are solutions.

At the most basic level, we need a global system for mandatory reporting, assessment, and appropriate dissemination of information on suspicious medicines. The seizure in Angola was first brought to public attention on Facebook after five months and then in the Wall Street Journal after eleven months.

Although such reporting is commendable, it is grossly inadequate for public health. What proportion of African malaria patients and their families read Facebook and the Wall Street Journal? Until recently no nation had legislation requiring the pharmaceutical industry to inform the national medicine regulatory authority of drug falsification. It is extraordinary that, in 2014, such systems are widely in place for fake aircraft parts but not for medicines.

Medicine falsification, unlike money counterfeiting, is not currently regarded as an international crime, making extradition and prosecution of criminals, such as those trading in falsified medicines between China and Angola, extremely difficult. We need an international public health convention that enshrines the crime in international law, allowing extradition, and helping countries to combat criminal networks. It could also provide a financing mechanism for supporting the many countries with insufficient capacity for the regulation of medicines. Indeed, the WHO has estimated that 30 per cent of countries have no drug regulation or a capacity that hardly functions. Functional national medicine regulatory authorities are essential for the interventions needed, and to ensure that the benefits of increased accessibility to internationally financed medicines and inexpensive generics are translated effectively into improved public health.

The enormous investment in increasing global accessibility of essential medicines without investing in checking and ensuring their quality is profoundly illogical. We cannot expect the world’s medicine supply to improve without coordinated functional national regulatory systems.

We need much more vigorous and urgent action to promote Access to Good Quality Medicines or the promise of beating malaria and other endemic diseases will be squandered.

Professor Paul Newton is the director of the Lao-Oxford University-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU), Vientiane, Lao PDR

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The 4 questions to ask any politician waffling on about immigration

Like - if you're really worried about overcrowding, why don't you ban Brits from moving to London? 

As the general election campaigns kick off, Theresa May signalled that she intends to recommit herself to the Conservatives’ target to reduce net migration to the “tens of thousands.” It is a target that many – including some of her own colleagues - view as unattainable, undesirable or both. It is no substitute for a policy. And, in contrast to previous elections, where politicians made sweeping pledges, but in practice implemented fairly modest changes to the existing system, Brexit means that radical reform of the UK immigration system is not just possible but inevitable.

The government has refused to say more than it is “looking at a range of options”. Meanwhile, the Labour Party appears hopelessly divided. So here are four key questions for all the parties:

1. What's the point of a migration target?

Essentially scribbled on the back of an envelope, with no serious analysis of either its feasibility or desirability, this target has distorted UK immigration policy since 2010. From either an economic or social point of view, it is almost impossible to justify. If the concern is overall population levels or pressure on public services, then why not target population growth, including births and deaths? (after all, it is children and old people who account for most spending on public services and benefits, not migrant workers). In any case, given the positive fiscal impact of migration, these pressures are mostly a local phenomenon – Scotland is not overcrowded and there is no shortage of school places in Durham. Banning people from moving to London would be much better targeted.

And if the concern is social or cultural – the pace of change – it is bizarre to look at net migration, to include British citizens in the target, and indeed to choose a measure that makes it more attractive to substitute short-term, transient and temporary migrants for permanent ones who are more likely to settle and integrate. Beyond this, there are the practical issues, like the inclusion of students, and the difficulty of managing a target where many of the drivers are not directly under government control. Perhaps most importantly, actually hitting the target would have a substantial economic cost. The Office for Budget Responsibility’s estimates imply that hitting the target by 2021 – towards the end of the next Parliament – would cost about £6bn a year, compared to its current forecasts.

So the first question is, whether the target stays? If so, what are the specific policy measures that will ensure that, in contrast to the past, it is met? And what taxes will be increased, or what public services cut to fill the fiscal gap?

2. How and when will you end free movement? 

The government has made clear that Brexit means an end to free movement. Its white paper states:

“We will design our immigration system to ensure that we are able to control the numbers of people who come here from the EU. In future, therefore, the Free Movement Directive will no longer apply and the migration of EU nationals will be subject to UK law.”

But it hasn’t said when this will happen – and it has also stated there is likely to be an “implementation period” for the UK’s future economic and trading relationship with the remaining EU. The EU’s position on this is not hard to guess – if we want to avoid a damaging “cliff edge Brexit”, the easiest and simplest option would be for the UK to adopt, de facto or de jure, some version of the “Norway model”, or membership of the European Economic Area. But that would involve keeping free movement more or less as now (including, for example, the payment of in-work benefits to EU citizens here, since of course David Cameron’s renegotiation is now irrelevant).

So the second question is this – are you committed to ending free movement immediately after Brexit? Or do you accept that it might well be in the UK’s economic interest for it to continue for much or all of the next Parliament?

3. Will we still have a system that gives priority to other Europeans?

During the referendum campaign, Vote Leave argued for a “non-discriminatory” system, under which non-UK nationals seeking to migrate to the UK would be treated the same, regardless of their country of origin (with a few relatively minor exceptions, non-EEA/Swiss nationals all currently face the same rules). And if we are indeed going to leave the single market, the broader economic and political rationale for very different immigration arrangements for EU and non-EU migrants to the UK (and UK migrants to the rest of the EU) will in part disappear. But the Immigration Minister recently said “I hope that the negotiations will result in a bespoke system between ourselves and the European Union.”

So the third question is whether, post-Brexit, our immigration system could and should give preferential access to EU citizens? If so, why?

4. What do you actually mean by reducing "low-skilled" migration? 

One issue on which the polling evidence appears clear is that the British public approves of skilled migration – indeed, wants more of it- but not of migration for unskilled jobs. However, as I point out here, most migrants – like most Brits – are neither in high or low skilled jobs. So politicians should not be allowed to get away with saying that they want to reduce low-skilled migration while still attracting the “best and the brightest”.

Do we still want nurses? Teachers? Care workers? Butchers? Plumbers and skilled construction workers? Technicians? If so, do you accept that this means continuing high levels of economic migration? If not, do you accept the negative consequences for business and public services? 

Politicians and commentators have been saying for years "you can't talk about immigration" and "we need an honest debate." Now is the time for all the parties to stop waffling and give us some straight answers; and for the public to actually have a choice over what sort of immigration policy – and by implication, what sort of economy and society – we really want.

 

 

Jonathan Portes is director of the National Institute of Economic and Social Research and former chief economist at the Cabinet Office.

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