Heard in Brussels

Keeping it local - be afraid of the CJEU
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Keeping it local - be afraid of the CJEU

12.03.2012 - In February, I heard of a slightly mad and very worrying trend in decisions handed down by the Court of Justice of the European Union (CJEU) with regard to IP issues handed up from the national level for clarification. IP is not very exciting to start with, but the more you understand about the situation developing, the more you see Europe backing itself into a corner about something that could have major ramifications for commercialisation of technologies.

It all started with IP for antibodies. As everyone in the industry knows, antibodies are incredibly complicated items in terms of IP - with a product that cannot be pinned to the wall accurately, and with post-translation modification and environmental factors influencing structure, activity and effect. This leads to long development times in groundbreaking regulatory and IP arenas. The supplementary protection certificate (SPC) in theory gives 5.5 years of extension beyond the original patent duration, and this has been used by a number of organisations to enable effective biological products to be protected to market. Of course, this is a very challenging area of IP, which was not designed to include biological entities, and which refers strongly to the regulations of the original patent. Increasingly, national patent offices are referring tricky cases to the CJEU for clarification, and this is where the wheels are coming off - with very serious consequences for the European commercial environment. Instead of casting light into the darkness, aside from a few notable decisions, the CJEU has instead returned slow, lengthy and impenetrable decisions that make it nearly impossible to make a national decision to grant an SPC. Clarification has been requested but actively avoided by the court, a great example being reference to 'non-European rules governing patents' but without actually saying which ones, even when asked a straight question on the matter.

National authorities are unable to interpret the legal way forward. "I am bound to say that I find this reasoning difficult to follow," says Lord Justice Arnold, and "not only has the Court not answered the question referred, but also the guidance it has provided is not sufficiently clear to enable future disputes to be resolved". Translation: it would seem that Europe has knitted itself a time-bomb for extending protection of biological products. The CJEU, through either a profound lack of understanding of the issues or through wilful incompetence, is preventing the successful exploitation of next-generation therapeutics, and can't be touched. The price will be paid by European companies trying to develop products, by researchers who have dedicated years to the innovation behind biologicals and of course by the patients, who may wait much longer for a groundbreaking therapy. Those products will one day be developed elsewhere and imported into Europe - exactly the opposite of the EC's drive to create a knowledge-driven economy ... and a mess of Europe's own making.


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.

13.05.2013 Brussels – Greetings readers! The observant of you will note that I have strayed far from Brussels in my quest for knowledge – I was lucky enough to attend the BIO convention in Chicago in late April, and where better to listen out for sage advice? So what did I hear?

Claire Skentelbery, Secretary General of the European Biotechnology Network

Well, apart from the great parties (Belgian café at Buddy Guy’s Legends Club) and my failed chance to win a motorbike in the exhibition hall, I learned something very thought-provoking from my favourite panel – a session focused on synthetic biology and its amazing potential.

I couldn’t possibly name the speakers, but it provided excellent insights into how much time large companies spend on processes that they would rather not have to do. If you run a large company producing novel crops, for example, you want to focus on the stuff you’re good at – producing the final crops themselves – rather than on time and money-consuming gene processing tasks. It’s not your speciality, nor is it your firm’s mission. So you have a list of the technologies that you wish existed to make your route to products faster and more effective.

And this is where it got exciting; synthetic biology opens up tremendous market opportunities for smaller companies that can deliver advances in tech tools for processes that large product companies would rather avoid. One such SME (Ginkgo BioWorks) was represented on the speaker panel, and they fill that gap precisely. Their technology can produce organisms to customers’ exact specifications. It was an eye-opening glimpse into how biology will soon be engineered from scratch, and why we will no longer just rely on tweaking existing genomes.

These companies are absolutely typical SMEs (Ginkgo was founded by PhD students). They had to beg, borrow and steal development funds to survive, and show the absolute necessity of genius. Only a bunch of fearless researchers would have founded this firm and invested in it for five years. I can’t see a large service provider investing the time, money and individual commitment required to bring this technology to fruition.

So the session reminded me of two things. The first is that behind every breakthrough product there is a whole pipeline of breakthrough technologies that enabled it. That’s the beauty of biotech of course. Every new field brings multiple commercial opportunities for other new technologies. The second thing – which governments everywhere need to remember – is that SMEs drive applications for inventions, and you ignore them at your peril. Ginkgo’s fantastic platform was enabled and supported largely through grants. Although it saw little private investment, the firm looks set to help power the next generation of bio-based products. The lesson? If you don’t support innovative SMEs, they can’t deliver.

I’m looking forward to BIO 2014 and hearing from a new wave of SMEs pursuing amazing technologies that will enable the next big product.

18.04.2013 March saw the publication of the latest innovation scoreboard. ‘More stats!’ I hear you groan, but this is important reading for researchers, businesses and governments in biotech. It tells you where the innovation leaders and followers are, as well as informing you about changes in performance over time.

Claire Skentelbery, Secretary General of the European Biotechnology Network

Unsurprisingly, the innovation leaders are Denmark, Sweden, Germany and Finland – countries that have long looked far ahead when planning strategy, and that have a strong national innovation focus. They don’t leave it to market forces to stimulate growth. Instead, they continue to innovate strongly in research and business, and the rankings are similar to previous reports. The innovation followers are Europe’s mid-table performers: the UK, France, Belgium, etc. Estonia and Slovenia signal a newer EU27 presence. These countries have varying strategies, as well as very different sizes and histories. They’re doing just fine in mid-table, with strengths and weaknesses in different parts of the economy.

Moderate innovators include Europe’s old school countries such as Spain, Portugal, and many of the newer EU27 members (Hungary and the Czech Republic jump out at you), as well as a ‘plummeting’ Greece (their words not mine). Modest (such a polite term) innovators bring in the final few stragglers, among them Romania, Bulgaria and Poland. So why is this important? You could probably guess without this report where countries score on innovation in research and business. It’s the figures behind the headlines that make for interesting reading.

A key comment was that declining innovation investment was linked to short-term decision making. Positive growth was linked to decisions made and stuck to. This is a key earning point for governments planning their life sciences strategy. Aim high, and stick to it. You give confidence to investors, researchers and companies when you plan 20 years ahead, and that’s repaid with skilled personnel, entrepreneurial SMEs and stable investment. In a sector like life sciences, only governments can create stable, long-term infrastructure for high-risk activities to take place and business to grow.

The headlines also hide the fact that innovation convergence between countries has pretty much stopped, which is a worry for the European project. After all, we are supposed to work together to bring everybody to the same level. There is a lot of pressure on national budgets, and those countries suffering the most are radically cutting their ability to innovate – and thus their ability to grow – over the long term. This means that you need to think beyond borders in supporting innovation. Disabling innovation elsewhere will also impact on you. So in the innovation race, there are two key lessons to learn for the life sciences: think big and plan long-term for innovation – while remembering that we have to innovate to survive. Help your neighbours in Europe to enable, not disable, their innovation systems.

14.03.2013 The end of the FP7 process has been a busy one, with a rush to grab the last EC funds before we all get thirsty in the break between FP7 and the launch of Horizon 2020 in 2014.

Claire Skentelbery, Secretary General of the European Biotechnology Network

And my, hasn't it been a busy time for all you clever SMEs out there! The results are in for the part of the Health call targeting SMEs (Innovation 2), with proposals requiring 50% of funding going to SMEs. There were two main topics in the call: the first on anti-infective research and the second in translating work from previous framework projects.

The EC has put its money where its mouth is for SMEs, which is great to see, with a140m available for the call. As well as targeting funding to SMEs, it has also made great strides in bringing a business focus to evaluation, with 72% of the evaluators coming from companies.

And the results? Pretty good. 58% of all that lovely money went to SMEs, with Germany, UK, France and the Netherlands taking the four top spots (Italy used to be right up there, I recall from my distant youth, but is looking a little sorry for itself these days). The average pass rate is about 40% for the UK, France and Netherlands, which is pretty good, while Germany has gone for a 'pile 'em high and sell 'em cheap' approach, with loads of proposals but a pass rate of just 25%.

A nice fact is that the targeted time from deadline to contract signature is to be just five months. DG Research & Industry has worked to respond to critics on access for SMEs and slow time scales, and this should be remembered when you next moan about EC funding. We're still waiting for the results of the main programme in health - which had 35 topics and a679m to spend - but there's plenty to take home from this first result.

Europe knows that it has to monetise its innovative research. The fact that we have stopped buying cars and other stuff made in factories in Europe has turned slick political phrases about innovation into urgent reality. We need the money back from research, and we need it now.

It's fantastic to see that the largest funding programme in Europe is doing just that; money is being channelled to SMEs, the translators of research from a dream to commercial reality. While the market in Europe won't fund earlystage commercial work (you idiots), governments and the EC are stepping into the gap. It's also a relief to see funding of translational work from previous Framework projects. Funding a single part of the value chain will rarely push a product to market, but sustained funding on evidence-based progress is sensible and a good use of money, and it also strengthens productive partnerships that keep their eye on the market. FP7 has evolved over its lifetime, and the early signs from Horizon 2020 indicate that the focus on turning technologies into economic returns will continue. Keep up the good work, girls and boys of DG Research & Industry, and we look forward to enjoying the fruits of the Framework tree!

14.02.2013 All the hard work I invested in 2012 to rescue the Eurozone with biotechnology has reaped a new reward in 2013, as the European Parliament and Council finally approved the European patent in December.

Claire Skentelbery, Secretary General of the European Biotechnology Network

All the hard work I invested in 2012 to rescue the Eurozone with biotechnology has reaped a new reward in 2013, as the European Parliament and Council finally approved the European patent in December. We can now look forward to a revolution in the commercialisation of innovation, as a unified Europe opens the doors to lower cost and wider impact patents. Many accuse the EU of over-caution, like an old lady wrapped up warm on a summer’s day, but this is a glorious example of Europe going a bit mad and dancing naked in the street. Metaphorically, of course. It’s far too cold for that in reality right now.

My friend Steven Zeman  can give you the formal overview of what the unified patent means for Europe (as he actually knows what he is talking about) so I will just relax and enjoy the feeling of freedom that the patent gives to technology in Europe.

I am intrigued to know how Europe will score on innovation rankings worldwide now, as universities can afford to protect more great science and SMEs don’t have to sell their grandmothers to bring their precious technology to an investable stage. We can expect to see far more patented innovations from collaborative research and people bold enough to take risks, as you have to do in biotechnology. We can also expect to see many technologies hitting the market at an earlier stage. Now you don’t have to hide it in your pocket for 10 years until you can finally afford that patent, or know for sure that it will do something.

Will this help to liberate Europe from its traditionally cautious approach to early-stage businesses? Let’s hope so. I would love to see European entrepreneurs seize the day and investors take early-stage opportunities more seriously. We yearn for the bold investments seen on the other side of the Atlantic. But money talks very quietly on this side of the pond, often because it is still muffled in the pockets of VCs who, in the face of early-stage companies, increasingly resemble me when my children describe the latest ‘must-have’ game or gadget, without which they will surely die.

This is not just about the point of purchasing patents. It’s also about the fact that it changes the whole value chain of innovation, and makes a serious statement from Europe as a whole. And that statement is that there might be a defragmentation of finance through the unfortunate situation of there being no money out there, but there has now also been a defragmentation of innovation because that is the right and glorious thing to do. Europe should be very proud of itself. Vive la revolution! 

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.

Claire Skentelbery, Secretary General of the European Biotechnology Network

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.

12.11.2012 We all read with dismay – but not a huge amount of surprise – the October paper from French researchers led by Gilles-Eric Séralini on the two-year rat-feeding study looking at the effects of glyphosate-treated GM maize.

Claire Skentelbery, Secretary General of the European Biotechnology Network

It‘s almost boring these days when new headlines emerge saying we're all going to DIE HORRIBLY from eating GM food. This is despite a conspicuous lack of people DYING HORRIBLY from anything other than the usual human-inspired causes, which are not worthy of comment or action because they are 100% ‘natural’.

In the bad old days, scientists, companies and politicians would have been looking the other way when the report was published, and before long the headline would have been accepted as fact. Any response would have been far too late and far too weak to look like anything other than an evil corporate cover-up.

This time, however, I was pleasantly surprised. As they raced to hit deadlines, I heard journalists adding that an awful lot of people disagreed with the results, and that the science was actually a bit suspect – not enough animals, dodgy design, cancer-prone rats and less maths than my budget planning for shoes. They also added, in pensive tones, that the researcher was a long-time opponent of GM crops, and this might mean he isn‘t exactly unbiased.

Even more refreshing was the rapid response from researchers and politicians. The latter got it badly wrong when the GM farce first hit the headlines. But then the French research community itself bit back quickly. The country‘s national academies of agriculture, medicine, pharmacy, sciences, technology and veterinary studies signed a statement that not only are the conclusions unsupported by the presented data, but that the paper spreads fear in the public. 

This was rapidly backed up by the European Food Safety Authority, which published a statement pointing out that the author had been invited to supply the evidence missing from the paper, but had obviously ”forgotten” to post it before their deadline. The full review from the EFSA contained the damning phrase “the study has unclear objectives and is inadequately reported in the publication, with many key details of the design, conduct and analysis being omitted. Without such details it is impossible to give weight to the results.” Dark words for any scientist to hear, and I’ll bet the peer review process in Food and Chemical Toxicology is now undergoing an overhaul.

Bravo, I say. The scientific community needs to manage its scientists better. It has been too easy for too long to grab headlines with poor but sensationalist science, and the price is paid by everybody.

When science is bad, it should be the scientists who point it out and remind their own community and the rest of the world that to be science, it has to be scientific – you don’t start from the result, and you always show the maths. Obviously, that doesn’t apply to shoes.

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