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active ingredient stated on the label, they did contain a drug called levamisole, a deworming medicine that has been withdrawn from human use in many countries due to severe side effects, including bone marrow failure.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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An unmatched font of knowledge

Edinburgh’s global reputation as a knowledge economy is rooted in the performance and international outlook of its four universities.

As sociologist-turned US Senator Daniel Patrick Moynihan recognised when asked how to create a world-class city, a strong academic offering is pivotal to any forward-looking, ambitious city. “Build a university,” he said, “and wait 200 years.” He recognised the long-term return such an investment can deliver; how a renowned academic institution can help attract the world. However, in today’s increasingly globalised higher education sector, world-class universities no longer rely on the world coming to come to them – their outlook is increasingly international.

Boasting four world-class universities, Edinburgh not only attracts and retains students from around the world, but also increasingly exports its own distinctively Scottish brand of academic excellence. In fact, 53.9% of the city’s working age population is educated to degree level.

In the most recent QS World University Rankings, the University of Edinburgh was named as the 21st best university in the world, reflecting its reputation for research and teaching. It’s a fact reflected in the latest UK Research Exercise Framework (REF), conducted in 2014, which judged 96% of its academic departments to be producing world-leading research.

Innovation engine

Measured across the UK, annual Gross Value Added (GVA) by University of Edinburgh start-ups contributes more than £164m to the UK economy. In fact, of 262 companies to emerge from the university since the 1960s, 81% remain active today, employing more than 2,700 staff globally. That performance places the University of Edinburgh ahead of institutions such as MIT in terms of the number of start-ups it generates; an innovation hothouse that underlines why one in four graduates remain in Edinburgh and why blue chip brands such as Amazon, IBM and Microsoft all have R&D facilities in the city.

One such spin out making its mark is PureLiFi, founded by Professor Harald Haas to commercialise his groundbreaking research on data transmission using the visible light spectrum. With data transfer speeds 10,000 times faster than radio waves, LiFi not only enables bandwidths of 1 Gigabit/sec but is also far more secure.

Edinburgh’s universities play a pivotal role in the local economy. Through its core operations, knowledge transfer activities and world-class research the University generated £4.9bn in GVA and 44,500 jobs globally, when accounting for international alumni.

With £1.4bn earmarked for estate development over the next 10 years, the University of Edinburgh remains the city’s largest property developer. Its extensive programme of investment includes the soon-to-open Higgs Centre for Innovation. A partnership with the UK Astronomy Technology Centre, the new centre will open next year and will supply business incubation support for potential big data and space technology applications, enabling start-ups to realise the commercial potential of applied research in subjects such as particle physics.

It’s a story of innovation that is mirrored across Edinburgh’s academic landscape. Each university has carved its own areas of academic excellence and research expertise, such as the University of Edinburgh’s renowned School of Informatics, ranked among the world’s elite institutions for Computer Science. 

The future of energy

Research conducted into the economic impact of Heriot-Watt University demonstrated that it generates £278m in annual GVA for the Scottish economy and directly supports more than 6,000 jobs.

Set in 380-acres of picturesque parkland, Heriot-Watt University incorporates the Edinburgh Research Park, the first science park of its kind in the UK and now home to more than 40 companies.

Consistently ranked in the top 25% of UK universities, Heriot-Watt University enjoys an increasingly international reputation underpinned by a strong track record in research. 82% of the institution’s research is considered world-class (REF) – a fact reflected in a record breaking year for the university, attracting £40.6m in research funding in 2015. With an expanding campus in Dubai and last year’s opening of a £35m campus in Malaysia, Heriot-Watt is now among the UK’s top five universities in terms of international presence and numbers of international students.

"In 2015, Heriot-Watt University was ranked 34th overall in the QS ‘Top 50 under 50’ world rankings." 

Its established strengths in industry-related research will be further boosted with the imminent opening of the £20m Lyell Centre. It will become the Scottish headquarters of the British Geological Survey, and research will focus on global issues such as energy supply, environmental impact and climate change. As well as providing laboratory facilities, the new centre will feature a 50,000 litre climate change research aquarium, the UK Natural Environment Research Council Centre for Doctoral Training (CDT) in Oil and Gas, and the Shell Centre for Exploration Geoscience.

International appeal

An increasingly global outlook, supported by a bold international strategy, is helping to drive Edinburgh Napier University’s growth. The university now has more than 4,500 students studying its overseas programmes, through partnerships with institutions in Hong Kong, Singapore, China, Sri Lanka and India.

Edinburgh Napier has been present in Hong Kong for more than 20 years and its impact grows year-on-year. Already the UK’s largest higher education provider in the territory, more than 1,500 students graduated in 2015 alone.

In terms of world-leading research, Edinburgh Napier continues to make its mark, with the REF judging 54% of its research to be either world-class or internationally excellent in 2014. The assessment singled out particular strengths in Earth Systems and Environmental Sciences, where it was rated the top UK modern university for research impact. Taking into account research, knowledge exchange, as well as student and staff spending, Edinburgh Napier University generates in excess of £201.9m GVA and supports 2,897 jobs in the city economy.

On the south-east side of Edinburgh, Queen Margaret University is Scotland’s first university to have an on-campus Business Gateway, highlighting the emphasis placed on business creation and innovation.

QMU moved up 49 places overall in the 2014 REF, taking it to 80th place in The Times’ rankings for research excellence in the UK. The Framework scored 58% of Queen Margaret’s research as either world-leading or internationally excellent, especially in relation to Speech and Language Sciences, where the University is ranked 2nd in the UK.

In terms of its international appeal, one in five of Queen Margaret’s students now comes from outside the EU, and it is also expanding its overseas programme offer, which already sees courses delivered in Greece, India, Nepal, Saudi Arabia and Singapore.

With 820 years of collective academic excellence to export to the world, Edinburgh enjoys a truly privileged position in the evolving story of academic globalisation and the commercialisation of world-class research and innovation. If he were still around today, Senator Moynihan would no doubt agree – a world-class city indeed.

For further information www.investinedinburgh.com