Heard in Brussels

Why biotech needs Europe – and Europe needs biotech
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Why biotech needs Europe – and Europe needs biotech

11.12.2012 - It’s getting a little boring listening to conversations about the 2014-2020 budget. As citizens, we’re subjected to endless national bickering and point-scoring as national leaders look to secure their own positions through sounding ‘tough on Europe’, as if the EU was a strange alien beast designed to steal their money and straighten all their bananas.

As a fugitive from the UK, I am particularly embarrassed, and can’t wait for them to have a referendum on in/out. At least the Brits will finally shut up afterwards.

But I digress. What people overlook is the impact of a big European freeze on national development. Europe has enabled the massive development of regions that would have been unlikely to see many benefits under purely national direction. This has created the infrastructure through which science is being delivered, and a consequence of reducing this now will be to throw away much of the progress and investment we’ve made to date.

Support on the Horizon

When not talking about biotech, I talk about cluster development (that’s right – I’m such a blast at parties) and right now we are witnessing a battle for survival. These precious structures are nurseries for economic returns on research. After 25 years of investment, they are creating SMEs that are coming through on promises, making the transition from discovery to clinical phases for new drugs – exactly what investment was intended to deliver.

However the market is moving further away from SMEs. The gap where they need support gets wider every year. So if investors won’t come unless you have a Phase III product, how do you get there? This is where the critical support from Horizon 2020 comes in. It must expand its reach beyond FP7, with cluster support, PPPs, later-stage trial funding, infrastructure creation, skills development and a relentless drive to support the commercialisation of great science. 

Savouring the fruits of innovation

If the funding falls away from Horizon 2020 as national governments reduce their input to Europe, then the countries themselves will pay the price. As national austerity reduces innovation support, Europe has in many places become the only source of assistance – both financially and strategically – when creating long-term plans as part of an international map. Kill it, and those clusters and regions that are at the cusp of economic delivery from biotechnology will shrivel, and the billions of euros invested thus far will be wasted.

Right now, Europe has an opportunity to seize the market. It would be a crime if short-term national political games prevented the strengths of 27 countries from finally delivering substantial economic returns in biotech.


20.05.2014 There are sinister moves in the world of data protection, and I need to mobilise you – my crack squad of guerrilla scientists. The EC is showing its ugly face, and it’s going to impact you.

Claire Skentelbery, Secretary General of the European Biotechnology Network

A new data protection regulation is being pushed through by the Commission, and it isn’t fighting fair. This is a regulation, not a directive like the one it replaces, and will be implemented word for word into national law, overwriting years of carefully developed legislation that protects consumers and science.

The regulation frankly sucks, and could have been written by a bunch of monkeys with typewriters. It potentially restricts access to data on a huge scale for research, and displays a profound lack of legal clarity or understanding of data use in science. It is so badly written that it will create legal uncertainty around any research carried out using pseudonimised or sensitive data, threatening products or processes from such research – a real killer for investment and exploitation. It will affect all research, so don’t feel smug if you are reading this from a university.

The ’ugly face’ is the strange situation where amendments from worried national governments appear to be sliding out of text prepared by the European Commission, which is very kindly helping out the current Presidency with some extra admin ’support’. Parliament is also confusing the scandal of data access by government security agencies with the use of data in research, and will vote through a draconian regulation that does nothing to stop the NSA reading your email and everything to stop you using data derived from patients, biobanks, etc.

Many governments oppose this, but run the risk of generating headlines about failing to protect their citizens. As we are close to elections, there is an almost tragic resignation to the fact that this regulation will come into effect, and efforts are being aimed at damage limitation rather than creating something genuinely useful. It is like replacing a brain surgeon with a child holding a blunt spoon. It didn’t always go right before, but it sure as hell is going to go wrong now.

This is a ridiculous and dangerous situation. European Commission, please listen to national concerns and improve this regulation. Make it legally strong, bring in specific, more sophisticated reference to the use of data in science, and listen to the countries that have spent years developing exactly this kind of legislation – they know what they are talking about. You are supposed to serve Europe, not impose your own underdeveloped opinions through a misuse of process.

And you, my fearless warriors, contact your MEP, your national government and your newspapers and tell them what this regulation will do to science in Europe. Make them bold enough to do something about it while they still can. If not, then the last one out of the lab should turn out the lights.

As we all know, the European Commission is under intense pressure to reduce costs and shed the image of being a gravy train. This is a favourite topic at the national level in the ongoing fight against the reign of terror from Brussels.

Claire Skentelbery, Secretary General of the European Biotechnology Network

The irony is that the era of eye­watering salaries and mansions on leafy avenues actually ended some time ago. While there are still plenty of Commission people who live very well ­– courtesy of getting their feet under the table back in the old days – many new staff face short contracts, lower wages and substantially less sexy perks. I am all for the European Commission employing people on a realistic level (i.e. like the rest of us), but I am having problems with additional changes in structure that somebody thought was an 'efficiency'.

One cut too many?

The EC is a huge funding body, driving innovation and industrial development across Europe. To do that, it needs passionate and motivated staff who are integrated into the heart of the scientific process. Based on what I have seen myself and heard from plenty of others, the increased use of external agencies to administer project funding isn’t serving collaborative research well. Sure, the agencies come cheaper and let the EC talk about reducing costs, but the direct result is that you get people paid to administer – not to add value to – world­class research collaborations.

Another irony is that there is a queue of people 10km long wanting to work for the Commission, and it includes talented scientists and project managers. So why make them just administer project reports? Managing collaborative research is really hard, we all know that, so why not invest a bit more to ensure that it actually works? These guys would work on the same salaries as you pay external staff. In fact, I bet that those external staff would jump at the chance to stretch their brains beyond correctly completed personnel tables.

Investing in results

The fact is that the European Commission will always take the heat for national issues. It is a useful whipping boy on any aspect of money because its budgets are so huge, and it always looks shifty because its answers are necessarily complicated. The Commission is not going to win any debates at national level, regardless of how much it cuts budgets, so it should stand up and say that it is proud to have skilled Project Officers working as partners with the projects that it funds. Then those projects have the maximum chance of delivering the results that they were funded to achieve, while the Directorates delivering the funding can also see the fruits of their labour and assess the effectiveness of their policies.

01.04.2014 Shhhhh, is that the sound of a chicken coming home to roost in Switzerland? Worried? If you are a scientist working internationally, you should be – and not just because you want a job in Switzerland.

Claire Skentelbery, Secretary General of the European Biotechnology Network

The result of the recent referendum on quotas for immigrants to the alpine country sounded a lot like the usual grumblings of discontent about how Brussels ruins your life by letting foreigners steal your jobs. Usually things like this have little real fall-out. This time however, there was a potentially disastrous impact for science in Switzerland almost immediately. The failure of the Swiss government to sign a free movement deal with Croatia - a direct result of the referendum - suspended talks for Swiss access to Horizon 2020.

Unintended consequences

I'll bet my last euro that this was not a topic of conversation when Swiss citizens were weighing up how to vote, and it is a massive wake-up call for all of us. The Swiss debate reflects arguments going on in our own countries, and the frankly disgracefully low turn-outs in elections. Voter apathy leaves the floor clear for people with 'interesting' views to shout loudly, and as they also tend to be keen voters, they often win. The Brits reading this will recognise the booming call of the swivel-eyed loon as it stalks the marshes of the south, and know the danger out there in the mist. If you are a scientist anywhere in Europe, you need to stand up and fight for the amazing scientific platform that it brings, and do some shouting of your own on why it is essential to vote to protect it. Switzerland has in fact done us a favour before the impending European elections by providing an example of what happens when you can't be bothered to vote, think that a sensible result must come anyway, or that results won't affect you. European science has already been hit by the repercussions of the Swiss referendum, years before the idiots that drove the yes campaign manage to implement quotas of any description. I want you to promise me now that you will start telling people how the science they need to save their lives, reduce pollution, grow their food and drive their economies (and cars) is delivered by international partnerships - a benefit that greatly outweighs a perceived blight upon their lives from people with different accents who might need to go to the doctor once in a while.

Every voice of reason counts

I also want you to promise that you will cast your vote in the European elections in May. It is time for scientists to rule the world, we can't trust anybody else to do it. As the great popular music combo Faithless would say, "inaction is a weapon of mass destruction". So head for the polls, my fearless warriors, and let the world hear our voice.

17.02.2014 I am spoiled for choice this month on things that make me happy about biotech. Three things have happened across Europe that confirm the field has great people that work hard, recognise the truth when it is kicking you in the ankle and aren’t afraid to try something different.

Claire Skentelbery, Secretary General of the European Biotechnology Network

Putting your money where your mouth was

The first was the news that the late Professor Sir Kenneth Murray, founder of Biogen, left £9m to the Darwin Trust of Edinburgh, and £2m to the Royal Society and various other organisations to support young biologists in doctoral studies. Here is a man who enriched the science and business of biotechnology throughout his career, and is now – even after his death – enabling promising scientists to follow his pathway in the best way … with hard cash. Professor Murray, we salute you and take a good hard stare at all those slightly less-deceased scientists who have made their money from mega-deals and exits. We know who you are, so if you are feeling both generous and perhaps slightly unwell, now is the time to reach for the quill and inkpot and make that gesture. Your kids won’t thank you, but we will.

A little ray of Golden sunshine?

Next is the great news that there is some positive spin in the press on GM crops, or at least something that moves the argument temporarily into a sphere of reality.  It is always welcome, even when both sides are masters of the PR (dark) art. People should think about the impact of crops such as Golden Rice on the health of people in economies far different from their own. Block this, actively denying nutrition to millions that need it based on your own principles – when you yourself have enough to eat – and what kind of person are you becoming? Someone who pushes over old people when they are indecisive in queues? Oh wait, that last one was me.

Good things come to those that mess about in labs

If proven to be replicable, the news that stem cells can be created just by dipping blood cells into acid is a great example of two things: (1) that it is critical to persevere with potentially great science, and (2) that you should always dream that you can have a breakthrough doing something really simple. Sometimes life is good like that.
So January was generous with great reports (apart from the being dead bit in the first story) and I have demonstrated all the impetuosity of a genius scientist by jamming them all into one test tube and heating it, rather than spreading them out over three sensibly planned columns. See you next time, and let’s hope that the gods of interesting science are as active in February as they were in January.

12.12.2013 Welcome to December, and a rather nautical analogy this month. I don’t mean the title of this piece literally of course – messing with nature is what biotech is supposed to do (in a well thought-out and good way, of course) and I stand up to be counted with all those people who mess about with what nature and evolution have so kindly provided.

Claire Skentelbery, Secretary General of the European Biotechnology Network

I’m referring instead to politicians who are seeking, with the best of intentions, to support the biotech sector and impose their own rather rosy view of what companies should look like. Trying to say what a biotech company should be is like trying to get a straight answer from a 10 year old to the question: “Why the hell did you do that?” You’ll get a different response every time, and it’ll be influenced by the least predictable of factors.

Navigating stormy seas

I have seen a number of politicians confuse high-risk, early-stage biotechs with 100-year-old engineering firms that have a Bentley parked outside. The mission of a biotech company is not to develop a firm with hundreds of employees (although that would be a nice side effect) but to deliver the firm’s technology to its destination. A company is a vessel for the precious technology that it holds. A firm is not the deliverable, but rather the small and leaky boat that must navigate a stormy sea. The current destination may not even be the final one. The goal might for example be a transfer to a larger boat, and a captain with a more luxuriant beard.

Too many politicians view a company’s size and age as the deliverable – but why would this be the case? You might keep your company afloat for 20 years, but if you delivered your product to its destination 10 years ago and you are now just bobbing about, then why does it still exist? If your technology is a platform rather than a product, that is a different question, of course – in that case, the technology is the very fabric of the company. But you can only continue to sail your boat if she is watertight, you have a good set of charts and there is a fair wind in your sails.

An eye on the Horizon

And this is where the politicians have to wise up. Don’t throw grant money at a company with your mission to attend its 20th Christmas party. Instead, give it to the company with a mission to celebrate the successful delivery of its cargo to its destination. And don’t worry about what happens to empty boats lost at sea. There are ZERO examples of successful entrepreneurs retiring and doing nothing. Most just end up building new boats, growing bigger beards and heading off on the next voyage.

So target the cargo, not the boat and those sunny shores of Europe’s biotechdreams won’t be far away. Leave the safety of the harbour and see where your voyage takes you.

19.11.2013 Hurrah for the news that a GM yeast has been developed that can convert crop waste into biofuel! Not just because this is an awesome thing in its own right (which it is), but also because it opens up the intriguing thought that we could start using those rascals to do lots of things that GM-doubters would like.

Claire Skentelbery, Secretary General of the European Biotechnology Network

This piece is not technically about something ‘Heard in Brussels‘ – rather a stream of consciousness from the inside of my head – but as my head is in Brussels, that will have to do.

What would we really like GMOs to be able to do? And what would instantly open the door to their warm embrace by people who previously thought that little Petronella would be intellectually stunted if a morsel of food sourced from a GMO passed her lips? Here I am specifically referring to the well-meaning monsters who feed their children organic beetroot-paste sandwiches (ignoring in the process their human rights by denying them actual food).

The brave new world of synthetic biology opens the door to any kind of GM capability that we like, so here‘s a few ideas on how we could sell it as the must-have middle class accessory for the following applications:

 By turning that supermarket T-shirt you guiltily bought for  Euro 2 into an organic, ethically-produced shirt, hand-woven by well-fed adults somewhere sunny that isn‘t falling down, war-torn or underwater

  By transforming your electric car from a mobile ‘rainforest resources on wheels‘ into something that has the energy footprint of a teenager on a sofa on a Saturday morning

  By enabling your local farming system to produce hummus, tahini, South American wine, and all those other things without which you can‘t have dinner parties, and so have to ship from the other side of the world, which rather rains on the ‘local produce only‘ parade embodied in that beetroot paste

  By converting fashionable gluten and dairy-free yoghurt from a habitat-destroying, palm-oil containing crime against food into something that makes you thin whilst containing ingredients that you have actually heard of

  By turning those delicious prawns from the product of a miserable, polluted swamp on the other side of the world into happy seafood that just fell asleep and was harvested by smiling artisan fishermen from the crystal waters of a tropical lagoon. That will probably do it. So boffins, rather than focussing on the undoubted evil of reducing use of pesticides and producing nutritionally superior rice, can you focus on all the critical things that blight the life of suburban Europeans? Then we can embrace GM technology, or at least add it to the list of stuff for which we ignore the production process. After all, we do so very much like the product.

21.10.2013 A recent interesting look at markets beyond Europe has given some interesting food for thought. You know, sometimes the EU is actually easier to do business in than many other places. Sounds a bit crazy, but compared with some emerging markets, Europe looks like a safe place to invest in the longer term.

Claire Skentelbery, Secretary General of the European Biotechnology Network

Much is still said about sexy new emerging markets. A few years ago, we were packing up to go to India, and the South American economies were apparently just waiting to take over Europe's life sciences sector. But as ever with such stories, the reality of these markets makes them much harder to access for R&D than headlines suggest. Europe's tendency to regulate everything is certainly a pain in the backside, but it makes it much easier to know what is going to happen in the longer term. You just have to worry about having enough money to last the week ...little things like that.

News from India that clinical trials have been suspended by organisations as big as the NIH tells you that an awful lot of money is suddenly flying out the window and delaying approvals. The reason behind the suspension is the introduction of new liability rules for trial sponsors, which creates uncertainly following a dramatic and poorly defined shift in rules. How many more changes will come - and how long before agencies conduct trials elsewhere?

Brazil is another interesting example; plenty of money and a market comparatively untouched by global competition. In theory it's a great new target for innovation and R&D. However, a closer look finds a much stickier situation. South America's giant demands a 100% transfer of rights for government procurement of technology, and offers an opaque approvals process in return. It's a tough market to crack for all stages of R&D. Universities in Europe are already muttering about freedom to use research results, while SMEs don't have the clout or money to create partnerships or new entities. That leaves only the big global companies to sell products rather than the innovation chain behind them.

Europe has had a painful learning curve in the process of regulation. The challenge of creating legislation for more harmonised operation between countries has ensured that regulation is long-term, and that it has been argued from the perspective of 28 countries. The process might be complicated, but you know it isn't going to change while you are making your precious investment. Europe also knows the importance of enabling technology development. An enforced loss of rights does nothing to encourage innovation, and frankly, it can't shovel research out the door of universities fast enough. I used to worry about Europe's over-zealous regulation - and there's no doubt we do an awful lot. It might have taken long years of defragmenting regional and national activities, but it seems we've finally managed to create a stable European platform.

18.09.2013 Europe has a wealth of talent and skills embedded in its regions, skills which are highly diverse and usually associated with a long history of trade and culture.

Claire Skentelbery, Secretary General of the European Biotechnology Network

The latest regional development policy – one that will underpin future structural fund spending – is “Smart Specialisation” – and it is coming to a region near you soon. What does that have to do with me?” I hear you cry. “I’m a scientist and wouldn’t know a regional policy if it bit me!” However, this is likely to impact everyone in the sector, particularly if you are an SME and rely on regional funds as part of your income. In a nutshell, 'smart specialisation' is a strategy for building commercial strength through an integrated approach to regional development that draws on a region’s strengths. Regions have to submit a 'smart specialisation' plan to the EC, and you can bet your bottom dollar (or euro) that you are going to see changes to regional investment based on this.

Making the smartest move

Smart specialisation is intended to foster entrepreneurship and innovation around a topic important to the region. It's a winner for those who find their business close to the smart specialisation strategy, since regional investment and funding should become more accessible. In biotech, however, Europe has always struggled with regional specialisation. Instead, universities usually create clusters around diverse research output, and I can’t think of a single cluster with a technology or application that creates critical mass.

This is where the problem may lie for biotechnology development. If your region creates a smart specialisation strategy that doesn’t benefit you, regional investment could dry up rapidly. Regional funding for environmental technologies or ICT won’t fund an oncology start-up.

Bioeconomy is the obvious winner in smart specialisation – especially areas like food production, which encompasses high-tech to low-tech industries and impacts directly on local landscape and production chains. This makes sense for European regions, most of which have local specialities and significant employment around food production. It also ticks the boxes for regional politicians, as you can see results quickly and locally.

But what of healthcare biotech? It doesn’t tend to employ high numbers over a wide spectrum. Results are felt globally, and local public awareness is often limited to a headline in the regional paper rather than a new factory or locally recognised product. I suspect that where there are no existing commercial activities in healthcare, it won’t feature in specialisation strategies. That will impact on tech transfer in the region’s universities, as most start-ups fall close to the tree.

As regions publish smart specialisation strategies, serious money will follow. Will Europe be able to build on regional strengths without stifling innovation in other sectors? We just have to wait and see.

15.08.2013 As Horizon 2020 takes shape, I was keen to read about the new public private initiative that will target the bioeconomy. Public private partnerships mark a significant change in how collaborative research is undertaken in Europe, and they are a logical progression from the requirement to work across national borders.

Claire Skentelbery, Secretary General of the European Biotechnology Network

The need to work more effectively through the value chain is an unsolved challenge, and PPPs can help break down borders. The groundwork for partnerships bet-ween the public and private sectors has been in put in place over the last few years within the life sciences, while a healthcare equivalent - the Innovative Medicines Initiative (IMI) - has provided interesting insights that could help teach us how to optimise a new generation of PPPs. One of the curious elements in the IMI is the fact that the 'private' side of the equation only includes large pharma companies, which collaborate with SMEs and academic researchers on the 'public' side. There was a noticeable gap in the company chain between SMEs and Big Pharma firms, as non-SMEs are not eligible for funding. This has always been odd, as many non-SME companies play a key role in the healthcare value chain, and also because you can't expect a smooth transition from the advanced technologies in academia and early-stage risk of SMEs into the close-to-market activities and structures demanded by companies at the other end of the chain.

A broader bioeconomy

The Biobased Industries Consortium (BIC) is behind the Bridge 2020 Public Private Partnership that aims to transform bioeconomy research and exploit-ation in Europe. Almost fifty companies - both large and small - have committed to the programme, giving it a budget of a2.8bn from the private sector boosted by a1bn from European Commission coffers. That's great news, as we know how fragmented life science value chains are. The bio-economy, which is trying to move cutting-edge tech into traditional and highly diverse sectors, poses a particular challenge. For a collaborative effort to truly deliver bioeconomy technologies to the market, you need to engage players at every stage of the chain. A clear market pathway that is defined by companies throughout the chain is going to be more effective than one defined by companies perched at the far end (and undergoing their own personal crises). I have high hopes for this Public Private Partnership. Europe is often slow and complex, but it is the only region in the world that makes a huge effort to cross difficult boundaries, and the rewards will come. Go bioeconomy - we're behind you all the way!

18.06.2013 Europe’s consumers have an often turbulent relatioship with science. Advice from scientists that clashes with lifestyle preferences finds governments reluctant to appear as over--zealous legislators, especially if it makes them unpopular with either groups of voters or the large companies that are often associated with the particular bit of lifestyle under threat.

Claire Skentelbery, Secretary General of the European Biotechnology Network

Things like high fat foods, alcohol and tobacco all have their proponents – some very vocal.

Ironically, in a situation where scientists have generally said “it’s OK” – in the case of food from GM crops – people didn’t believe them. Of course, hysterical media reports and poor company management of the situation didn’t help. Now we have an interesting scenario where it could be the other way round: the question of accessibility in direct-to-consumer (DTC) genetic testing without face-to-face counselling.

Caution from clinicians

A survey conducted by INSERM and the KU Leuven has revealed that the vast majority of clinicians would prefer such testing to be linked to face-to-face genetic counselling (see p. 12). Where the associated condition was untreatable or unpreventable, almost 100% of clinicians wanted this direct patient contact. Indeed, the German Ethics Council recently recommended to its government to lobby for international rules on DTC testing.

Of course, DTC is a growing business in Europe – a shift towards US healthcare models where patients receive direct marketing on all aspects of healthcare (OMG, have you seen the adverts?). The quandary for European governments is around their favourite catch-phrase, “consumer choice”. Should consumers be free to take genetic tests without clinical advice, and possibly make poor lifestyle or treatment decisions based on a meaningless result? We all know people who have had food intolerance testing, and subsequently decided to stop eating nine out of ten food groups because a nice man off the Internet said they would probably blow up and die if they continued to eat bread.

However, legislating on precautionary advice from clinicians risks annoying consumers who might like to take a test to see if they are special, as well as of course those nice (hopefully) tax-paying companies that provide such tests. I suspect that national governments will fail under pressure from them, so this is something that Brussels can step up to do. Because it is the right thing to do.

Being the bad guy

One thing Brussels is very good at doing is taking the blame for implementing legislation at the European level on nationally unpopular issues like pollution, water quality or human rights. So it might as well do the right thing on genetic counselling, and add it to the list for beleaguered national politicians to rant about.

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