Expert opinion

Genome editing:  Don’t cross the Rubicon
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Genome editing: Don’t cross the Rubicon

11.06.2015 - Modern biotechnology has already helped many patients and we need to continue research and development because many diseases cannot be cured yet. However, inappropriate use of technology has serious side effects for patients and society. That is why strict rules – if possible at cross-national level – are necessary.

Until recently, there had been consensus that intervention in the human germ line is not acceptable. Where EU Law is applicable, we have fixed this limitation, for example in the Clinical Trials Directive. The technology cannot be patented under the Patent Directive and its support under Horizon 2020 is not possible. Also, the much bigger Council of Europe (including e.g. Russia and Turkey as well as the 28 EU member states), has banned germ line intervention in its Convention on Human Rights and Biomedicine.

Why is an intervention in the human germ line unacceptable? Any medical intervention is linked to a risk. Intervening in the human germ line is of particular high risk and, most importantly, there is not only a risk for the baby created but also for all future generations. We definitely do not know enough about the complex interaction of genes and their different functions to manage this risk. 

A very important principle of medical ethics is informed consent. No baby created by germ line intervention can give its
consent and of course future generations cannot, either. To develop the technology it is necessary to manipulate and destroy hundreds or even thousands of human embryos. Babies created by germ line intervention are in fact experiments themselves. To allow intervention in the human germ line it would be necessary to set a limit and to define a normal human being. Even though with today’s technology, influencing human intelligence is not possible, but of course everybody knows intelligence is partly determined by our genes. It is a question of medical definition to call a human being mentally handicapped. Depending on how one defines the threshold more or less people are underperformers What kind of limit would allow intervening in the human germ line? Similar examples can be found e.g. in the size of people. 

For whom all the ethical arguments are not convincing – I think they are but there may be some stakeholders for which they are not – I would like to add an argument that
Edward Lanphier, chairman of the Alliance for Regenerative Medicine in the USA, and CEO of Sangamo Biosciences, alongside with other high ranking representatives of science and biotechnology used in an article for Nature: “We are concerned that a public outcry about such an ethical breach could hinder a promising area of therapeutic development...” I am sure there would be a great public outcry and the scientific community is well advised to concentrate on the huge amount of alternative approaches that are not ethically controversial. 

Dr. Peter Liese

For more than ten years Liese (50) worked as a physician before he was elected a Member of the European Parliament in 1994 for the Christian Democrats (European People’s Party, EPP). He is a member of the Committee on the Environment, Public Health and Food Safety (ENVI), where he has also been coordinator of the EPP Group since 2009. In addition, he is deputy member of the Committee on Foreign Affairs. Peter Liese has been board member of the CDU since 2012.

04.11.2013 The start of Europe's new financial framework and the framework research programme Horizon 2020 seems a good moment to take a step back and look into some recent and not so recent - but even more substantial - changes in (bio-)technology policy paradigms.

Peter Schintlmeister, Austrian Federal Ministry of Economics, Family and Youth

From technology-orientation towards justification: In 2002, the European Commission (EC) published its first overarching strategy for Life Sciences and Biotechnology. The focus then was clearly on new technologies and their promise. Meanwhile policy mainstream has changed and all technological efforts are superseded by the need for justifying the possible contribution to society's 'Grand Challenges'. In practice, even technologies that have been politically identified as 'key technologies' fall under this regimen, which in turn narrows horizons for possibilities outside this scope. The good news for cutting-edge science and technology, however, is that new and more precise instruments (e.g. the ERC) are easily countermanding the loss of focus on technology.

The loss of the knowledge-base: the term 'knowledge-based bio-economy' first appeared on the radar of technology policy in 2005. At that time, it was totally in line with the (Lisbon) goals of making Europe competitive through enhancing its knowledge-base. When the 2012 strategy 'Innovation for sustainable growth: A Bio-economy for Europe' was published, the term 'knowledge-base' had interestingly disappeared from the title (although it still appears in places on the website). While this move widens the base of stakeholders significantly by embracing entire traditional industries like agriculture and forestry, it still has to be shown whether Europe can maintain a focus on innovation. This trend can also be seen in the composition of the new Bio- economy Panel, which is aimed at providing the European Commission with feedback from the community.

The shift from supply- to demand-side of technology policy: A couple of recent studies concur on the necessity of keeping current austerity measures in place in most EU Member States, and have concluded that investing taxpayer money in technology-based areas might only solve the technological side of the problem. Bringing innovation to the market - an area where Europe has a notoriously bad track record - is a wholly different affair. The Commission's Lead Market Initiative has sought to balance out issues by emphasising the importance of (low-cost) political measures, such as streamlining the regulatory framework, labeling and certificate schemes (both admittedly tasks worthy of Sisyphus) and enhancing the efficiency of standardisation. The technologypolicy community has recognised that the measures are bringing results, and they have acquired prominent positions in current high-level strategies like Europe 2020 and the Innovation Union. This will enable them to make a positive difference in the years to come.

European policies are about the larger and broader vision, but most of the impact they have still derives from the national implementation that takes place farther down the road. The Greek philosopher Heraclitus is attributed to have said that the only constant in life is change - and that aphorism applies to policies as well!

Peter Schintlmeister

joined Austria's Federal Ministry of Economics, Family and Youth in 2003 as an expert for life sciences and biotechnology. He has enjoyed chairmanships at a number of different entities, including the OECD Task Force on Industrial Biotechnology, the ERA-NET EuroTransBio and the European Commission's Advisory Group on bio-based products for the Lead Market Initiative. Schintlmeister is a member of the European Bioeconomy Panel and the Commission's expert group for bio-based products. He has spent the better part of 2013 in China, where he has been contributing to the establishment of Austria's Office of Science and Technology in Beijing.

26.09.2013 Biosimilar products are not generic medicines, nor are they identical to their reference product or each other. Instead, they are similar versions of well-established recombinant proteins with well-characterised structures and pharmacology. All biologics (biosimilars and reference products) have complicated safety and immunogenicity profiles.

So far only three classes of biosimilar have been approved for use in the EU (somatropins, epoetins and GCSFs), but a second generation of biosimilars is on the way that focuses on more complicated molecules – such as monoclonal antibodies and fusion proteins – to help patients fight diseases like RA and cancer. This has been made possible by the EU’s science-led regulatory framework, which has established confidence in the quality of existing biosimilars. Various biosimilars are currently in different stages of clinical development and regulatory approval in the EU, and biosimilar regulatory pathways are also in place in countries like Canada, the US and Australia. 

Biosimilars have been providing alternative therapeutic choices for European patients and physicians since 2006. The European Commission recently completed an exhaustive study on the introduction of biosimilars into European medical practice, and determined that their availability is helping increase market competition.

Although the available commercial data says otherwise, some claim biosimilars have had a disappointing introduction, and that regulators and politicians need to do ‘more’ to spur their uptake. As a representative for a company developing several biosimilar medicines, I tend to disagree. It’s important to let the market decide, and ensuring patient safety should be the foremost concern for both governments and the biosimilars industry. 

There have been significant advances in our ability to use analytics to better understand the biology of both reference product and biosimilar. However, we haven’t yet (and may never) reach a stage where biosimilars should not be absolutely required to exhibit fidelity to their reference products and be rigorously evaluated in analytical, non-clinical and clinical comparisons. 

The industry has an obligation to take proactive steps to be accountable to providers and patients for product quality. For example, all stakeholders, manufacturers, regulators and healthcare professionals should embrace pharmacovigilance and naming systems that allow all biologics to be properly identified and traced in cases of adverse events. The EU’s pharmacovigilance legislation addresses this, and will help instill further confidence in the field.

It’s evident that high-quality, reliably supplied biosimilars can offer additional choices to patients and other key stakeholders, although development and supply of these complex medicines is scientifically challenging and capital-intensive. We now know manufacturers need significant expertise, infrastructure and capital to successfully develop these molecules. 

The healthcare community, industry and regulators have a key opportunity – to work as partners to ensure appropriate standards for these products are maintained. As we at Amgen move forward with developing our own portfolio, we know our experience is critical in a field where patient safety and reliability of supply are paramount concerns.

Carsten Thiel

is the Vice President and Regional General Manager of Amgen Europe. He joined the European oncology franchise in 2002, and held the post of General Manager for Amgen’s Central and Eastern European operations from 2006-2007 before taking up duties as General Manager in Germany from 2007-2010. He moved to his current post in 2011.

In September of last year, the European Commission presented a proposal concerning a revision of the in vitro diagnostics medical devices (IVD) Directive. The European Parliament and Council will negotiate the concrete wording of the regulation in the coming months, which means it will probably enter into force within the next three to five years.

Many people consider the IVD medical devices regulation the "little sister" of the Medical Devices Regulation, which will be discussed in parallel in European institutions. In my opinion, however, IVD medical devices are less the "little sister" than they are the "parents" of medical devices. Indeed, in some ways they are the progenitors of all therapies, including pharmaceutical products and surgery. Without a proper diagnostic, there can be no proper treatment or prevention of diseases. Unfortunately, the current directive from 1998 has not stopped low-quality IVD medical devices from reaching the market. In the past, there have been cases where low-quality HIV tests were placed on the European market with a CE-label. In one particular instance, a scientific institute had determined even before the notified bodies approved the CE-label that a test delivered many more false negative results than other available HIV tests. In other words, it sometimes said there was no virus present when in fact a subject had contracted the disease. Patients in the EU were given this test for years. When it comes to patient safety, we have to strengthen our system. Similar cases have been reported with hepatitis C, which is still a life-threatening disease that cannot be treated properly.

Another report highlights a different facet of the diagnostics problem. Francis Collins - who headed the Human Genome Project - once sent samples of his own DNA to three different laboratories and received three different results predicting his risk for contracting certain genetic conditions. That's why I also believe it is indispensable to include some basic criteria at a European level for the application of genetic tests.

The Commission proposal focuses very much on the quality of a product. But experts and many international organisations - including the Council of Europe, the OECD and the European Society for Human Genetics - have articulated again and again that in many cases, the framework in which the product is applied is even more important than the quality of the product itself. When it comes to DNA testing in particular, it is very important to respect the principle of informed consent. The European Parliament has requested this several times. A legal opinion concludes that it is possible and appropriate to introduce respective wording in the proposal. Therefore, I have proposed respective amendments together with colleagues from all political groups and different countries on this issue. There is a consensus that it should not be the intention of the European Union to limit patient access to DNA tests, but that appro-priate genetic counselling should be offered in cases of predictive and prenatal diagnostics in order to inform patients properly about possible results before a test is performed. To respect the principle of subsidiary, it should be left to Member States to regulate details, and individual Member States need to have the option to go further than regulations require. One could even argue that it should be mandatory to include informed consent in the proposal, because it is a crucial element of the Charter of Fundamental Rights (Article 3) - a legally binding document for the European Union in those areas where it acts.

Peter Liese

was elected as a Member of the European Parliament in 1994. He is Chairman of the EPP Working Group on Bioethics in the European Parliament and a member of the Committee on Environment, Public Health and Food Safety (ENVI), as well as a substitute member of the Committee on Foreign Affairs and member of the delegation for relations with the countries of Central America. During this legislative term, Peter Liese became a co-coordinator for the EPP Group in the ENVI committee. Before going into politics, he worked as a doctor in a pediatrics hospital in Paderborn (Germany), and spent six months in Central America working in a state-owned hospital and on foreign aid projects. Liese received his medical degree from the University of Bonn's Institute of Human Genetics in 1992.

02.07.2013 As part of the outcomes of the European Commission’s Process on Corporate Responsibility in the Field of Pharmaceuticals from 17 April 2013, Member States formally endorsed recommendations on a potential coordinated and collaborative approach to address access to orphan medicinal products: the Mechanism of Coordinated Access to Orphan Medicinal Products (MOCA).

These recommendations – which have been developed collaboratively by a group of EU Member States, patient organisations, industry representatives and other stakeholder representatives – are aimed at exploring ways to increase patient access to Orphan Medicinal Products (OMPs) through cross-border cooperation.

The key conclusions and deliverables include a proposal for a “Transparent Value Framework” (TVF), which would form the basis for a structured discussion between all stakeholders around the value of an individual OMP. This would create a shared understanding between stakeholders, laying the foundations for different pricing and reimbursement discussions in individual countries.

A variety of aspects should be taken into account during this process, including the severity of the disease, the availability of other treatments as well as the impact of the new treatment on disease progression. Rarity is also a key aspect, because it increases complexity throughout the process. In many cases, an OMP might be the only available treatment for the rare disease in question. Therefore, the ability to assess its value and to make it available within a national healthcare system in a timely way is vital. The TVF attempts to capture these points and to provide the beginning of a framework for discussions around the value of an individual OMP in national healthcare systems.

The multi-stakeholder dialogue surrounding the shared challenges in ensuring that OMPs get to patients in a timely and sustainable way is also a key deliverable of the two-year MOCA process. Improved cooperation between stakeholders and across geographical boundaries is vital to giving European patients with rare diseases access to innovative and effective therapies.

The MOCA recommendations will, however, only create meaningful change for patients if there is a concrete strategy and action plan to develop the next steps that must be taken to have the necessary multi-criteria and multi-stakeholder discussions involving OMPs. Many issues still have to be resolved, and a number of steps still need to be taken to improve access to OMPs in Europe – including the need to ensure that Health Technology Assessments are able to effectively capture the value of an OMP for patients.

This sector is affected by a multitude of different factors, systems and actors. Each stake-holder within the process has a part to play. But only through a collaborative and connected approach involving all stakeholders - industry, patients, national HTA agencies, clinicians, payers and national healthcare authorities - will we be able to ensure that patients have access to the treatments they need. The joint work on the shared challenges over the past two years should now lead to the next steps as we move to increase access to rare disease treatments across Europe. Industry is looking forward to being part of that ongoing process.

Wills Hughes-Wilson

is Vice President External Relations & Chief Patient Access Officer at Swedish Orphan Biovitrum (Sobi). She is also Chair of European Industry Task Force on Orphan Drugs & Rare Diseases – a joint industry trade association group between EBE-EFPIA and EuropaBio, and is also an Industry Member of the European Commission’s EU Committee of Experts on Rare Diseases (EUCERD).

28.05.2013 In a post-petroleum society, biorefineries - along with the farmers and foresters who source raw materials - are at the heart of the economy. No matter how you define it, the concept remains the same: converting raw materials into useful products for society. Instead of fossil fuels, the biobased economy employs renewable resources and wastes to produce a series of products useful to society: biofuels, bioenergy, biochemicals, bioplastics and other biomaterials.

The potential social, economic and environmental benefits of this model are substantial across Europe. Farmers and foresters would play a pivotal role in enabling the biobased economy's goals of delivering locally-sourced and produced materials, chemicals, fuels, food and feed. With sustainability at the heart of the biobased economy, growth could be decoupled from resource depletion and environmental degradation. That would in turn boost the EU's ability to transition more rapidly to a low-carbon and resource­efficient society, and it would further enable the EU to lead and compete in a global biobased economy market that is expected to reach the 200bn mark by 2020. The biobased economy is just the project to propel Europeans onto the path of reindustrial­isation and sustainable growth, and to reverse the current investment trend toward other regions of the world. It offers a road back to prosperity across all of the regions in the EU, and creates new jobs that will not simply disappear in the mid to long term. It will build on existing EU strengths and resources, embracing technological and scientific excellence, and creating new and novel partnerships between industries that have thus far remained unconnected. Supplementing food production, the conversion of bio­mass into bioproducts will likewise present a chance for the EU27 agricultural and forestry sectors to diversify revenues and revitalise rural areas.

For about a year now, industries across sectors have come together to discuss partnership opportunities with the EU. The resulting effort is called BRIDGE - a proposed "Biobased Industries Public-Private Partnership" in the form of a Joint Technology Initiative (JTI) known as the "Biobased and Renewables Industries for Development and Growth in Europe."

BRIDGE is a €3.8bn commitment (EU: €1bn, Private sector: €2.8bn) over the 2014-2020 period, with a clear strategic research agenda that includes defined focus areas for demonstration projects and a set of flagship initiatives. Research institutes, academia and SMEs have been playing and will continue to play a crucial role in the PPP. The same goes for Member States, which will be instrumental in the process - particularly during the project deployment phase. The PPP might have been conceived in Brussels, but it will be implemented at national, regional and local levels across Europe. A Biobased Industries PPP in the form of a JTI is sending the right signals to invest in Europe, as well as to translate the EU's R&D potential into new, innovative and sustainable biobased products and markets.

By the end of June 2013, the European Commission is scheduled to propose a (recovery) package of JTIs aimed at stimulating growth and jobs and improving the quality of life in Europe. BRIDGE will be among these initiatives. The proposals are to be passed on to the European Parliament and the Council of the European Union for approval. The Biobased Industries Consortium (BIC) is calling on EU legislators to support the Commission JTI proposal for BRIDGE in order to unlock the biobased economy potential and trigger more sustainable growth in Europe.

Dirk Carrez

is the Coordinator for BIC, an industry consortium that includes more than 40 European companies and organisations from the fields of technology, industry, agriculture and forestry that are preparing the Biobased Industries PPP. Carrez is also the Managing Director of Clever Consult, a consulting firm dedicated to different aspects of the bioeconomy. He is currently the Vice-Chair of the Biotechnology Committee at BIAC (Business and Industry Advisory Committee to the OECD) and the Vice-Chair of the OECD’s Task Force for Industrial Biotechnology.

30.04.2013 The proposal for an in vitro diagnostics (IVD) regulation currently under discussion in the European Parliament and Council of the European Union will chart the future of the regulatory system for IVDs in Europe.

Dubbed the "father of healthcare" by rapporteur of IVD Regulation Peter Liese, the various rounds of discussions are beginning to underscore the importance that IVDs have in healthcare as a pathway for guiding patient management decisions. And with this recognition, an important and more detailed look at the propo-sal is also starting to take place.

It's clear that IVD manufacturers will be controlled more strictly under the new re-gulations, and that notified bodies will also be more deeply involved. With the new classification system, they will have levels of oversight in about 90% of all IVD applications. However, the involvement of reference labs - which will provide a pool of scientific expertise to authorities and notified bodies, and test samples collected through unannounced visits - will mean dealing with new operators in the future.

Specific device types are currently being highlighted, and special care is being taken to ensure that they are safe and effective. This is the case for companion diagnostics, where there is a need to ensure that both IVD authorities and medicinal products authorities are satisfied that personalised medicine is delivering on the promise it holds. The same holds true for near-patient testing systems, which are growing in importance as a means for ensuring that testing results actually reach patients and have an impact in managing their health. Finally, it is important to underline that the specific requirements for IVD software will enable a better integration of the information that is transferred from IVDs to information systems.

The regulation takes a balanced approach between pre-market and post-market controls. In the pre-market setting, the use of Common Technical Specifications (CTS) for the highest risk IVDs continues to provide a very stringent requirement that has to be met before a diagnostic reaches the market. In addition, all IVDs will now have to be supported by clinical evidence. This is to include not just their analytical performance, but also clinical performance and scientific validity - in other words, knowing how the information that is generated by the IVD benefits the patient.

A lot of the questions that have been raised by the regulation will be addressed through the way in which it is implemented. In this, it is essential that implementation be driven by the need to ensure the safety and effectiveness of IVDs, while at the same time retaining relatively rapid access to the market for them. Only this combination will result in direct benefits to both the patients and the users of these devices.

Industry will have time to adapt, but that time must be used wisely. Collecting clinical evidence must begin as soon as the details are finalised. Those companies that begin an early programme of implementation will be in the best position to benefit from the advantages of the new system, which will include greater international convergence, as well as an increased confidence in a more stringent - but possibly still supple - system for regulating IVDs.

Jesus Rueda Rodriguez

heads the regulatory team of EDMA and ensures the association's active participation in the regulatory debates that affect IVDs in the EU. He is also involved in work at the international level, acting as the EDMA representative to the WHO and ISO, as well as a liaison to other associations on regulatory matters.

12.04.2013 The use of diagnostic testing is at the centre of Personalised Healthcare (PHC), not only for classifying a disease but also for determining which therapy will be most suitable for an individual patient or a stratified group of patients suffering from that disease. It is all about improving outcomes and tolerability.

Dr Hagen Pfundner, Chairman of the German Association of Research-Based Pharmaceutical Companies (vfa) and General Manager of German Roche Pharma AG

This concept keeps transforming oncology, and has made its debut in other therapeutic areas like neurology as well. PHC represents not only medical progress, but also highlights the potential to improve cost-efficiency of healthcare delivery by helping to avoid ineffective or even harmful therapies. To fulfill this potential, however, it must find its way into routine healthcare practice. Until now, this has all too often remained a long and winding road.

The European Medicines Agency (EMA) and the European Commission embraced the concept of PHC from the beginning, and continue to encourage manufacturers to include up-front testing (patient stratification) in clinical trials design and subsequently in labelling for new drugs, provided the scientific evidence is sound.

However, drug approval by the European and national health authorities is only one step on the “road to the patient”. Delays most often occur when it comes to including newly-defined tandems of a drug and a diagnostic test (companion diagnostic) in national reimbursement schemes. Procedures and processes for this step are different in every European country, but there appears to be a common theme: no healthcare system is prepared to handle the situation in a synchronised fashion or within a reasonable time frame. In the out-patient setting, a newly-approved drug is reimbursed following health authority approval, but a new companion diagnostic test – even if mandatory by label – is not. These reimbursement decisions are made by a different body made up of health insurance companies and associations of office-based physicians that organise physician fees. In the past, decisions have often taken several years.

In the US, the Food & Drug Administration (FDA) is moving towards encouraging regular testing as the preferred model for companion diagnostics in PHC. It has issued guidance focusing on the dependency of Rx and Dx co-approval, while the tests have been provided as a service by specific laboratories.

So while PHC is meant to shorten the time it takes for a patient to receive the most suitable treatment, in practice medical treatment is often delayed for many patients due to a misalignment of the two divergent reimbursement systems for drugs and companion diagnostics. This is unacceptable for modern European healthcare systems, and provides a disincentive for pharmaceutical and diagnostic companies. The irony is that while the scientific advances of PHC have opened the door to significant improvements in therapeutic and cost efficiency, the current healthcare systems are not equipped to benefit from them. Last but not least, the barriers also run counter to government efforts and support aimed at making Europe the leader in PHC research.

There is no “one size fits all” approach in Europe when it comes to including innovative PHC treatments in national reimbursement schemes. But national stakeholders should increase their efforts to resolve this in their countries – and not just in their own interest. Patients, physicians and innovators deserve it! 

Hagen Pfundner

joined Roche Pharma AG in Germany in 1992. Since 2006, he has held the post of General Manager at Roche Pharma AG in Germany. Since 2008, he has also been a member of the executive board of the German pharma association vfa. 

21.02.2013 In an era when Member States are doing their utmost to limit national exposure in the EU budget, making the right choices has become more crucial than ever before to shaping Europe’s future.

Derrick Williams, European Biotechnology Network, Brussels

The problem with the current tenuous economic situation is that research-driven sectors like biotechnology need reliable support. Without it, they will be unable to deliver jobs and growth in the global markets of the future – among them biological production, personalized medicine and health-enhancing nutrition. To remain at the forefront of these fields and employ funds effectively, Europe has to foster even more collaboration, while at the same time putting frameworks in place to prevent research projects from being being carried out more than once.  Both Big Pharma and global agribiotech players have to fully implement biotechnological platform technologies in product development. To improve their products, global industry leaders – like BASF in chemistry, for example, or Nestlé in nutrition – increasingly rely on biotechnologies invented by academic groups and perfected by life sciences SMEs. While this biologisation of industry is moving forward at a global scale, continuous support for collaboration is essential to ensure that innovations continue to flow steadily in both directions. In the past, Europe has supported R&D collaboration with significant amounts of funding (Framework Programmes) as well as through the creation of European research infrastructures provided by the the European Strategy Forum on Research Infrastructures (ESFRI). One example is the EU biobanking resource BBMRI, which is aimed at pooling data from local biobanks in Europe and harnessing it for drug target and biomarker discovery. This lays the foundation for personalised medicine and therapies that target diseases where they need to be battled – at their roots. Better collaboration and data standardization are key to squeezing the greatest possible gain from pooled resources. That rule of thumb is also true for other collaborative EU projects that generate huge datasets for the research community. To ensure that public funds are invested well, one fairly simple step would be to make collaboration and standardization of research outcomes – i.e. by means of ring tests – a prerequisite for EU funding. This would help improve comparability in research results, and prevent duplication in research projects. The only way to guarantee the high-quality results that future markets will demand is through collaboration and networking in the 27 Member States of the European Union, Switzerland and Norway. Only through collaboration among all the stakeholders in the value chain can we set the common standards necessary to take full advantage of vast projects, like searching cancer patient genomes for new targets and diagnostic biomarkers. Realizing European synergies can only happen, however, if potential partners are aware of one another. EU science, research and industry has yet to make really good use of the advantages provided by a common market, when these could be helping to drive even faster technology transfer and even more flexible labour. And at the end of the day, establishing a truly sustainable future through biologisation will never be achieved without even more political commitment.


Derrick Williams

Derrick Williams is the head of communications at the European Biotechnology Network in Brussels. A biologist, the US native is a science correspondent and media professional who has worked in Europe since 1996. Williams is a journalist and PR professional in a variety of different formats, including both broadcast media and print. His productions, TV reports and articles generally focus on helping the wider public better understand biotech and life sciences topics. 

21.12.2012 The revision of the EU Medical Devices Directives (MDD) could not have come at a more critical moment. The recent PIP breast implant incident has made it crystal clear that healthcare actors must pull together to ensure similar cases of fraud never happen again.

Serge Bernasconi, Chief Executive Officer, Eucomed, Brussels

We believe Europe needs a clear, predictable and effective regulatory system that deserves patient trust – a system that provides them with safe and timely access to the latest innovative technologies. The European Commission has tabled a proposal, and we welcome the majority of their recommended measures. They improve patient safety, do not unnecessarily delay patient access to life-saving medical technologies and do not hamper innovation. The proposal is on the right track in several key areas, and we applaud the Commission’s calls for improving notified bodies, increasing EU Member State coordination on vigilance and establishing a central registration database that can be accessed by governments and patients alike.

But as we work together towards an improved system, we must remember that the current decentralised notified body system has provided a high level of safety, and consistently granted people in Europe the very fastest access to life-saving medical technologies.

We are convinced that, with the support of a regulatory framework that successfully marries safety and the availability of new technologies, we can remain in this privileged situation in Europe. The Commission’s proposed “scrutiny procedure”, however, represents a step in the wrong direction. When considering changes to the EU regulatory framework, we must strive to answer three questions:

1. Will the changes improve safety for patients?

2. Will they allow life-saving medical technologies to be made available to people in Europe just as fast as they do today?

3. Will they encourage the innovation that European healthcare systems urgently need to become more efficient?

In the case of the scrutiny procedure, we believe the answer to all three of these questions is “no”, and therefore strongly oppose the proposed measure. The procedure will fundamentally change the current system, but will not lead to the desired outcome: increased safety for patients. It would address some calls to move towards a centralised, pharmaceuticals-like system, but will ultimately harm European patients and negatively impact European small and medium sized enterprises (SMEs). Recent independent research has shown that systems like these (similar to that at the US FDA) delay patient access to new technologies by 3 to 5 years without delivering additional safety.

Europe needs a decentralised system that is specific to medical devices if it is to maintain safe and timely patient access to technologies, and keep Europe’s medical technology “innovation engine” running.

We are committed to providing medical technologies that improve people’s lives and that are at the same time cost-effective. Europe has become a leader in healthcare innovation, and now more than ever it needs to cope with increased pressure on national healthcare budgets. The current regulatory framework has provided a high level of safety for patients in Europe without delaying access to life-saving medical technologies. Let’s not unnecessarily drive Europe’s strong innovation and research capabilities to other continents at a time when they are urgently needed here.  

Serge Bernasconi

Serge Bernasconi, currently the Chief Executive Officer of Eucomed – the European Medical Technology Industry Association – has more than 30 years of experience in the worlds of pharmaceuticals and medical devices at companies such as Johnson & Johnson, Schering Plough in the US and Europe, and more recently Medtronic. In his capacity as President & International Regional Vice President of Medtronic France, Bernasconi was elected President of APIDIM (The French Association for the Promotion of Innovation in Medical Devices), and Vice President and Treasurer of SNITEM (French Medical Technology Industry Association).

20.11.2012 Partnering and even open innovation is becoming increasingly important for our industry in a world where health systems are undergoing profound transformations.

Nigel Sheail, Head of Global Business Development & Licensing, Bayer HealthCare, Leverkusen

As the global population has grown above seven billion, emerging markets have become major markets. Mature markets around the world are aging. These factors and others are giving rise to greater medical need at a time when many health systems are reaching their financial limits. One key to addressing these challenges is innovation – both internal and external. 

In this context, partnering plays an important role. At Bayer HealthCare, we are committed to research & development in areas with high medical needs like oncology, cardiology, gynecological therapies, hematology and ophthalmology. Our partnering activities are also addressing both regional and local business needs, and we are constantly looking for new collaborations with academia, pharma and companies in the biotechnology field across all phases of the value chain to combine the innovative science of our partners with our drug discovery activities, our development experience and our marketing expertise worldwide. 

Today, we are well-positioned, with a strong portfolio of innovative products and an outstanding pipeline of new developments. However, to add more value for physicians and patients, our company is seeking to think beyond the scope of individual products and increasingly develop healthcare solutions. In the cardiovascular area, for example, such solutions could start with prevention, encompass diagnosis and treatment where disease does occur, and also protect against recurrence – a truly comprehensive approach to heart health. Following the idea of developing innovative solutions, as well as individual products, our business deve-
lopment organisation brings together colleagues from Pharmaceuticals, Consumer Care, Medical Care, and Animal Health divisions. 

One of the unexpected benefits of the tight financing environment over the last few years is that companies are forced to collaborate early on in the drug-discovery and development process. This may allow the next generation of molecules to benefit from ‘collaborative advantages’ – bringing together the science and experience of organizations for mutual benefit, and ultimately increasing the chance of developing new therapies that will have an impact. These days, more than 80% of Bayer HealthCare meetings at partnering conferences deal with pre-clinical opportunities. 

Our company is open to all types of collaborations, but prefers structures that allow both partners a seat at the table and real input to ensure the best decisions are made for the programs. We want to work with strong partners that thrive independently, and ideally will bring multiple opportunities to the table. We also recognize the need to meet the needs of investors who will need successful exits if they are to have confidence to reinvest in healthcare innovation

The growing importance of collaborations in our industry is also nicely reflected by the demand for, and increasing number of, partnering events worldwide. Events like the upcoming Bio-Europe offer excellent opportunities, both to catch up with companies we already know and to meet new companies or academic institutions at an early stage of their development. 

Nigel Sheail

Nigel Sheail, has been a member of the Bayer HealthCare Executive Committee and Head of Global Business Development & Licensing since November of 2011. The biologist (BSc, University of Edinburgh) began his professional career in the pharmaceuticals industry in 1990 at GlaxoSmithKline, before transferring to F.Hoffmann-La Roche Ltd. in 1993. There he held a variety of positions with increasing responsibility in both the firm’s finance and research organisations. Prior to joining Bayer HealthCare, Sheail was Head of Corporate Mergers & Acquisitions and Head of Global Pharma Licensing at F.Hoffmann-La Roche Ltd. in Basel.

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