Biomedical research faced with ‘bottleneck’

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The development of new drugs is slowing to a temporary standstill, according to medical research experts, who say harmonising Europe’s fragmented network of biobanks could help unclog the bottleneck.

Officials from the Biobanking and Biomolecular Resources Research Infrastructure (BBMRI) are in Brussels this week to discuss strengthening ties between biobanks in EU countries and developing uniform ethical and quality assurance procedures. 

They said helping researchers to make more efficient use of blood and tissue samples stored in hospitals and laboratories could cut the cost of drug development and help produce targeted therapies for serious illnesses. 

“If you look at the drug development scene right now, it has almost stagnated,” said Prof Eero Vuorio, from the University of Turku in Finland. “The fragmentation and lack of harmonised standards is one of the biggest bottlenecks we face in biomedical research.” 

He said better diagnosis and more efficient clinical trials could unlock a new wave of advances in medical treatment. 

According to Vuorio, who is executive director of the BBMRI, the pharmaceutical industry and academic researchers can use material stored in biobanks to help ensure that the right medicine is prescribed to patients, thus saving time and money. 

“This is often referred to as personalised medicine. People are diagnosed better and they get more targeted treatment. This is one of the reasons biobanks will play a very important role in the development of drugs from a totally different perspective,” he said. 

“It is also absolutely certain that if you can perform your efficacy studies on fewer patients, this is a major cost and time saver. Drugs will be developed faster and more efficiently.” 

Obstacles 

However, a range of barriers to harmonising biobank procedures in Europe remain, including ethical aspects of using tissue samples for research. 

Vuorio said permission to use samples is generally not needed when blood samples are routinely taken during a medical diagnosis in hospitals. 

However, for some collected samples, people are invited to give their informed consent for medical research, including storage in biobanks. 

“These rules, unfortunately, are very different in different countries. We have essentially very similar data protection legislation but it is interpreted in different ways,” he said. 

The OECD is currently preparing a document on human biobanks and genetic databases which Vuorio believes will have a strong impact on national legislation in the EU. The OECD guidelines are expected to include a strong focus on informed consent which would pave the way for common standards of how biobanks in Europe should collect material. 

Ethics 

Prof. Kurt Zatloukal of the Medical University of Graz in Austria, who is the coordinator of the BBMRI, said local ethical committees will have an important role in deciding whether scientists will access information and tissue stored in biobanks. 

“Informed consent is key for all biomedical research. You have to have informed consent for any research done on biological materials or analysis of medical data,” he said. 

He said evidence-based protocols can be followed when harmonising quality standards but reaching consensus on ethical aspects of biomedical research is more complex. 

“We have to accept that ethics has a close relationship to the cultural, historical and religious background of a country and there are differences across the EU. We want to see what the common denominators are and these can become the guiding principles,” Zatloukal said. 

Access 

Access to public biobanks has also generated some debate with varying rules from country to country on whether commercial researchers should have access to public material. 

The BBMRI said having industrial partners in international research projects is not ruled out but some countries are troubled by the prospect of pharmaceutical companies profiting from developments using biobanked tissue samples. 

Vuorio said public biobanks have tended to provide industry with access to data rather than access to the samples. He said new treatments arising from research on such material could lead to new intellectual property and this may belong to the researchers rather than benefiting those who donated tissue, cells or blood. 

“Although the samples are extremely valuable, people tend to forget that the samples don’t really contain IPR as such. The information derived from the samples is where the IRP arises,” Vuorio said. 

The BBMRI has already completed a comprehensive review of existing technology and is hoping to improve interoperability between Europe’s biobanks. 

Vuorio said Europe has considerable strength in this area and has an opportunity to make progress in a range of areas, including rare diseases. 

“If you look at the traditions of systematically collecting samples and inviting the public to participate in collective studies, that is a northern European tradition. But Austria has the biggest biobank in Europe and there is genuine strength is all over,” he said. 

Collections of biological materials such as DNA, tissues, cells or blood can be stored in biobanks to help scientists conduct research into cures for diseases. Samples are usually anonymised or coded so that researchers cannot identify the individual whose tissue or blood they are working with. 

There are at least 92 biobanks dotted across Europe, but the system for collecting and using the material varies significantly from country to country. In 2008, the Biobanking and Biomolecular Resources Research Infrastructure (BBMRI) was set up, with an initial budget of €5 million to improve coordination between biobanks. 

The BBMRI is one of 44 initiatives funded by the European Strategic Forum on Research Infrastructures (ESFRI), supported by the EU's Seventh Framework Programme (FP7). 

Last month, the European Council adopted a regulation to treat this type of research infrastructure as international organisations for taxation purposes (EURACTIV 03/06/09). This specific legal framework, which includes a VAT exemption, will cut administrative costs and facilitate the establishment of large and complex facilities, like the BBMRI, based in multiple European countries.

  • Nov. 2009: OECD to adopt guidelines on biobanks and genetic research databases.

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