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It is now well known that Germany is able to test for coronavirus on a far greater scale than the rest of Europe. The way in which the country has managed to scale up its capacity is truly remarkable. It provides lessons for other European countries – such as France and the United Kingdom – which are now struggling to ramp up their capacity.
The effort is most impressive because of the speed at which Germany’s efforts have been accomplished. Countries such as South Korea and Taiwan, which have combined mass-testing with highly effective contact tracing, have been preparing for a new respiratory disease such as that caused by the new coronavirus for many years.
Germany, however, appears to have simply responded rapidly to an unexpected and sudden – if not entirely unforeseen – global health crisis.
The President of Germany’s Robert Koch Institute – the public body in charge of the country’s response to infectious diseases – said on 20 March that German laboratories are able to conduct as many as 160,000 PCR tests per week. This was based on an average of the numbers of tests the country had performed in the two months up to 15 March.
The RKI now believe that they can produce up to 500,000 tests per week.
In Britain, the UK government announced on 11 March that it hoped to increase testing to a total of 10,000 PCR tests daily in the week beginning 23 March. But the figures from the Department of Health and Social Care show that the UK has been carrying out roughly between 5,000-8,000 tests per day.
The UK has conducted fewer tests per million people of its population than the US and Germany. But it remained slightly ahead of other European countries, such as France and the Netherlands, on this front quite recently (20 March).
The German effort also outgunned that of the United States in the early stages of the pandemic. While Germany was rapidly rolling out tests across February, the US Centre for Disease Control carried out fewer than 4,000 tests between mid-January to 28 February.
What explains the disparity between efforts in the UK – as well as similar countries – and Germany to quickly scale up testing capacity? Why is it that two developed liberal democracies have such different outcomes in their efforts to rapidly respond to the coronavirus crisis?
One reason for this is timing. German virologists – working with the country’s public and private sectors – responded particularly quickly to develop a diagnostic test for SARS-CoV-2.
Already, on 16 January, before the World Health Organisation had concluded that the novel coronavirus could be transmitted from one human being to another, German scientists had produced a diagnostics test.
On 16 January, researchers from the German Centre for Infection Research (DZIF) at Berlin’s Charité-Universitätsmedizin announced that it had developed a laboratory assay to detect the new coronavirus. In the press release, Professor Christian Drosten, Director of the Institute of Virology at the University, announced that the test would “help scientists understand whether the virus is capable of spreading from human to human.”
It was these German tests which proved to be one of the first reliable means of detecting the virus. These were then rapidly produced and adopted by the World Health Organisation, which then managed to ship more than 1.4 million tests by the end of February.
By contrast, the UK’s own effort only got going a month later. Public Health England decided to develop its own diagnostic test. This is not an unusual course of action for a country’s public health authority. The US Centre for Disease Control also opted for the same course of action.
The logic behind taking the time to develop a diagnostic test is that it allows for a country’s public health authority to check – according to its own procedures – whether a test is reliable and accurate. It ensures that they can have absolute confidence in the quality and efficacy of the test being used by its own citizens.
It is essential that validating the test is done well, because there have been coronavirus tests produced at great speed which have later proven to be inaccurate. This has most recently been the case with one PCR test kit provided by a Chinese biotech company, Bioeasy, to the Spanish government.
The kit was shown to be worthless, after the Spanish Society of Infectious Diseases and Clinical Microbiology found that it had an accuracy rate of less than 30 per cent.
Taking the time to ensure the quality of a test is important. What this approach does mean, however, is that it takes more time to get going.
As a result, Public Health England only began rolling out its diagnostic test on 10 February. And it was only at this date that the UK began to increase its diagnostic capacity to 12 regional labs dedicated to carrying out the processes required for PCR testing.
In the United States, manufacturing problems with early test prototypes combined with the exacting standards of the CDC to stall the US’s campaign. At the beginning of March the Vice President, Mike Pence, conceded that the US did not “have enough tests today to meet what we anticipate will be demand going forward.”
The US’s testing efforts have only got firing in the final week of March. According to the WHO’s figures for the 29 March, the US was still lagging behind Australia, Russia, Germany, and South Korea in the number of tests conducted per one million people of the population.
The challenge created by arriving this late in the game is that the level of international demand for supplies is now extremely high. As governments across the world race to boost their ability to perform large numbers of tests, the materials needed to create them are under strain.
On 12 March, Stephen Hahn, the chief of the US Food and Drug Administration, warned a subcommittee of the House of Representatives that there was “pressure in the supply system on the reagents” needed for testing.
A reagent is a substance which is used to cause and facilitate a chemical reaction. The method of testing for the virus responsible for the COVID-19 pandemic, SARS-CoV-2, is called PCR testing, or polymerase chain reaction. The reaction which provides a result in the test relies upon a number of reagents to work – one called “primers” and another called “DNA polymerase” are particularly important.
These reagents are produced by biotechnology companies which specialise in engineering goods such as reagents, catalysts, and compounds with applications in immunology and virology – including the PCR test for COVID-19.
In the UK, there are now also potential supply-side problems holding back the ability of the country’s labs to get hold of key reagents.
Dr Andrew Beggs explained yesterday in a thread of tweets that the coronavirus testing lab being set up at the University of Birmingham is having particular trouble with getting hold of primers. He also revealed that a reagent, known as the “RTQPCR master mix”, is “difficult to get hold of and when it does come, ship dates aren’t guaranteed”.
The issue here, Beggs explains, is that “we don’t usually make a lot of these things in the UK – apolitically we rely a lot on the EU and US supply chain, which has been significantly disrupted.”
On the other hand, Germany could be particularly well-equipped with a supply of reagents. It is Europe’s manufacturing powerhouse with a strong tradition of research in natural sciences, and particularly chemicals, and engineering.
This traditional economic strength, built upon a bedrock of manufacturing goods and large-scale technical industries, is mirrored in the country’s biotechnology sector. Germany is home to one of the world’s leading biotechnology industries, with important clusters in the Rhine-Neckar Triangle, Cologne-Düsseldorf, Berlin-Brandenburg, and Munich.
This is not to say that the UK does not have world-leading academics and world-class centres of research – it does. But the economies of UK and Germany are structured in different ways and with different priorities. The UK’s economy is services-led. The German system combines efficient services with a tradition of high quality goods produced on a vast scale. And when it comes to the supply of reagents, the issue is quite simply one of scale.
The turnover generated by German dedicated biotech companies was EUR 3.54 billion in 2016.
Having such a vast national resource in the private sector has probably provided Germany with the ability to quickly mobilise relatively large amounts of reagents and biotechnological materials required for its mass testing. It’s supply is not unlimited – but such a large domestic biotech industry provides a good platform from which to expand COVID-19 testing capacity.
Yet here is the curious thing. According to the UK Office for Life Sciences, the turnover generated by research and development in the British Biotechnology sector amounted to a very healthy £4.2 billion in 2018.
Of course, turnover is not as reliable an indicator as revenue figures. And this gross figure also does not give us a guide to precisely what products and companies are being produced for either country. There might conceivably be a large biotechnology sector in the UK, but with few companies providing reagents.
Still, these figures do suggest that a lot of investment is going on in UK biotechnology, potentially even more than is taking place in Germany. It would appear to be a tremendously significant national industry. Yet it seems that the UK has so far struggled to mobilise it.
There is another dimension which could explain why Germany has such a lead in testing over the rest of Europe. This is not only an issue of speed and supply alone, but also of institutions and policies. In order to appreciate why this may be the case, it is necessary to delve into how public health and public epidemiology work in Germany.
At the centre of the German federal government’s efforts is the Robert Koch Institute, the country’s central scientific institution in the field of biomedicine. As the RKI explains on its website, its remit is focused specifically on the “identification, surveillance, and prevention of diseases, especially infectious diseases.”
The RKI was set up in 1995 in agreement with the German Federal Ministry of Health, to provide a “public health microbiology system” – “The general goal of this system is to improve the efficiency of infection protection by advising the authorities on possible measures and to supplement infectious disease surveillance by monitoring selected pathogens that have high public health relevance.”
In other words, the RKI is not so much an all-encompassing Public Health Authority as a coordinating centre for epidemiological, immunological and virological laboratories and research.
What the RKI provides is a network of public, private, and university laboratories and research facilities to cooperate in identifying solutions to diseases which threaten public health. Its network consists of 20 National Reference Centres and 38 Consultant Laboratories, which are reviewed on a three-year basis. These labs are spread across the federal states, with one further bi-national consulting laboratory in Austria.
The RKI’s activities are to be distinguished slightly from public health policy which in Germany is highly decentralised. This is because Germany’s federal constitution guarantees that certain policy areas – such as health, education, and cultural affairs – are within the jurisdiction of the states (the Länder) rather than the central government.
This means that there is not one public health authority but approximately 400 different authorities throughout the Federal Republic. The heart of public health is at the local level, with health authorities and departments run by municipality and rural district administrations.
These bodies retain significant control over their own ability to legally regulate and promote health care, public hygiene, and the prevention and control of diseases. In practice, the states often cooperate to provide certain common high standards and levels of quality in healthcare, but the power to manage policy remains with the state legislatures.
This combination of a well-coordinated central advisory body with strong, decentralised public health authorities appears to have significantly helped Germany provide an effective testing programme from an early stage.
In fact, this structure seems to have been vital. Christian Drosten, the Director of the Institute of Virology, explained in an interview with Washington D.C.-based NPR radio recently: “We have a culture here in Germany that is not supporting a centralized diagnostic system. So Germany does not have a public health laboratory that would restrict other labs from doing the tests.”
Drosten believes that this has ultimately meant quicker, earlier and broader testing across Germany.
Unlike testing efforts in the US, which were controlled from the beginning by the CDS, or the UK, where Public Health England led the way, the creation of the first diagnostic test in Germany was led by the academies and the private sector.
It was a biotech entrepreneur, Olfert Landt, who spearheaded the efforts to get a diagnostic test for SARS-CoV-2 off the ground. As soon as he heard about the novel coronavirus, he mobilised the resources of TIB Molbiol, his Berlin-based biotech company, to collaborate with virologist in Berlin’s Charité university hospital.
The result is that the diagnostic developed by TIB and Berlin’s Charité – the latter of which is also an integral member of the RKI network – had produced a viable test by 16 January. Then, by mid-March, they had created as many as 4 million test kits, which were then used in Germany and around the world by the WHO.
Both the UK and the US have private companies which could have fulfilled a similar role to TIB. The US is home to large companies such as Roche and Thermo Fisher, which have now gained the approval of the FDA to produce their own tests.
The UK, meanwhile, is the base for the global diagnostics firm and manufacturer, Randox. Yet again, it seems that it was only in mid-March that the UK’s public health authorities began getting more private companies involved with efforts to ramp up testing.
It was on 18 March that The Times reported Sir Patrick Vallance explaining that PHE hoped to mobilise “the private sector” to expand testing “so we can get things out there fast on the community side”.
It was only as recently as Sunday 22 March that one private company was sent an email from the government asking for them to lend all available testing machines “for the duration of the crisis.”
And, then, on 27 March, Michael Gove, the Cabinet Secretary, announced that the government had set up an alliance between businesses, research institutes, and universities to increase testing capacity.
Crisis, once again, has been the locomotive of history. It is still possible that these measures have come in time to combat the peak of the infection.
Ultimately, institutions seem to be important in all this. Without the same restrictions and regulations of a central public health authority, private companies and local authorities in Germany have been able to move quicker to provide diagnostic PCR tests. As a consequence, the states and local governments have been proven to be much more responsive to popular demand for testing.
Yet Germany could still rely all the while upon the expertise and authority of the RKI and its network, including Charité in Berlin, not only to assure the quality of these tests – but also to advise and provide specialist laboratories for the state governments who were seeking to rapidly roll them out.
Once again, none of this is to detract from the fact that the UK is a world-class, and world-leading, centre of scientific research and biotechnological industry. What the different outcomes on testing so far do suggest is that the UK’s struggle to ramp up testing is rooted in how public policy-making has shaped Britain’s ability to respond on an institutional level.
The UK does not lack microbiological laboratories, cutting-edge research institutes, or brilliant researchers. Quite the reverse. Public Health England has a number of public health laboratories which provide a number of centres of regional excellence. The Scottish NHS provides a further 13 specialist labs in Edinburgh, Glasgow and Inverness.
Then there are the biosafety laboratories of great institutions such as the Francis Crick Institute and the Centre for Emergency Preparedness and Response.
Here, the UK’s problem appears to be not so much that it lacks resources, but that it doesn’t quite have the right structures in place to mobilise them.
PHE, which is coordinating the development and rolling out of the tests for SARS-CoV-2, cannot be compared to the Robert Koch Institute. And the government’s chief advisers, Professors Chris Whitty and Patrick Vallance, have lead the way and are coordinating policies with health authorities in Wales, Northern Ireland, and Scotland.
Unlike the RKI, the UK’s public health authorities have a wider remit than immunology and virology, however important these functions are. PHE’s responsibilities include commitments to “promoting healthier lifestyles” as well as providing a “specialist workforce” for “immunisation and screening programmes”. Like PHE, Northern Ireland’s Public Health Authority is also responsible for social care research and development as well as redressing “health inequalities”.
On the one hand, therefore, the UK seems to lack the more decentralised health authorities which drove demand for testing in Germany, and on the other the more specific and coordinated central network represented by an institution like the RKI.
Public health is decentralised among the UK’s devolved assemblies. But when it comes to the approval of testing kits, the UK’s approach has been – as we have seen – at first more centralised and top-down than in Germany.
At the same time, several experts have told Reaction that the UK’s microbiology testing capacity before the current crisis had also been significantly streamlined, centralised, and optimised over a long period.
Drives for savings have made the UK’s public microbiology network highly efficient, but unaccustomed to such a large and unexpected surge in demand. The sudden nature of the crisis is particularly unfortunate, given that building up to greater capacity in this area takes a great deal of time and resources.
Many experts fear that the way in which reforms to the UK’s lab networks have been carried out has left a system which is not designed for rapid community testing. A number of hospitals have had their own microbiology labs closed, as competency and equipment were transferred away from professionals on the ground and towards regional specialist centres.
As a consequence, laboratories which are used to processing hundreds or thousands of samples per day are now suddenly being asked to carry out tens of thousands with only a short amount of time to prepare. This is not an easy task for a process which has to be handled with great care and requires specialist training.
Alexander Edwards, Associate Professor in Biomedical Technology at the University of Reading, said that “Public Health England and our public health bodies remain excellent and they have clearly done their utmost to respond rapidly to the threat posed by COVID-19. They deserve to be commended for all their hard work.”
However, he adds that several “unforeseen consequences of government policies which were pursued over a long period of time might have contributed to the challenges faced by the UK’s health authorities. It’s difficult to tell and no doubt we’ll know more once the crisis is over.”
It is possible that, in looking to alleviate the debt burden incurred by the global financial crisis, successive British governments have created conditions which in their turn have made responding to today’s global health crisis more difficult.
Yet if institutions have been streamlined in the UK, assessing the amount of investment poured into research and development for biotechnology and the prevention of infectious diseases is not quite so straightforward.
There do appear to be disparities in investment when looking specifically at infectious diseases.
According to Public Health England’s Annual Report and Accounts from 2017/18, £80 million of the net operating budget went towards “protection from infectious diseases.”
In 2017, the German Federal Budget invested EUR 100 million into research and development for the Robert Koch Institute alone. A further EUR 73 million was poured into the Paul-Ehrlich Institut for vaccines and biomedicine in Langen.
Although, it is possible that such figures may look less impressive once they are offset against a larger population.
There are also encouraging signs when looking at the resources invested in research and development by the British Biotechnology and Biological Research Sciences Council (BBRSC) in particular. In 2018-2019, UK Research and Innovation reports, the BBRSC spent a total of £297 million on infrastructure and ideas.
It seems likely that, moving forward, the UK will seek to make specific biotechnological research into ways to combat viruses and preparations for potential pandemics much more of a priority for public policy. Politicians and think tanks may have to consider how Britain can better harness its considerable domestic funding, talent, industries and institutions to fight future pandemics.
Ultimately, as with many decisive moments in human history, the course of events might simply be down to chance and contingency. It may be that one group of individuals – German scientists – was quicker than others to grasp the true nature of the situation.
One of the causes for caution among several European governments and scientists, even as late as February, was clearly an uncertainty as to whether the new coronavirus would spread aggressively within Europe.
Based upon the experience of SARS in 2003 and MERS in 2012 – neither of which spread virulently in Europe – there were justified grounds for scepticism that SARS-CoV-2 would prove to be different.
As Alex Wickham, Political Editor of Buzzfeed, has pointed out today, the UK’s lower testing figures may also be the consequence of earlier policies. According to Wickham’s sources, the reorientation of the UK’s strategy away from larger scale testing in the community was a decisive moment. It saw the health authorities pivot instead towards the most severely ill in hospitals as a part of the UK’s earlier plan to mitigate, but not entirely suppress, the virus. The UK’s original plan to develop herd immunity, this argument goes, meant that widespread testing was not a priority.
The precise decisions which were made at crucial moments will be examined once the COVID-19 pandemic has passed.
It’s possible that Germany’s virologists were simply monitoring the possibility that a respiratory disease might spread to Europe with more urgency, while health authorities elsewhere were allocating more resources to other, equally important, concerns.
It seems that this dimension of public health management – investing in infrastructure geared towards monitoring and responding to the threat of infectious diseases – has simply been a better resourced part of public policy in Germany.
In a review from the RKI in 2010 on health risks to Germany, the institute noted that “the SARS epidemic and the spread of avian influenza plainly show that new infectious risks can, due to international air traffic and global trade, reach virtually every corner of the Earth within hours or days.”
Written in the aftermath of the global financial crisis, this observation seems prescient now – and it probably seemed wise to many scientists at the time.
But in many states, with the public and the country’s politicians groaning under the pressures of the still-recent credit crunch, the threat of a global health crisis did not register as the most pressing issue of the day.
Only time will tell how successful Germany, and indeed the UK, have been at protecting their citizens not only from the collapse of healthcare systems, but also from a longer-term social and economic fallout created by the response to COVID-19 itself.