In this section, biotechnologie.de has summarised a number of recent and relevant news from the past month:
ECJ challenges France's cultivation ban for GM crops +++ Biopharmaceuticals: less of a burden on health system than expected +++ Bayer to expand plant biotechnology arm +++ Bayer and TU Dortmund build model production line +++ Blood test detects serious diseases by the dozen
ECJ challenges France's cultivation ban for GM crops
The European Court of Justice (ECJ) has declared that France’s ban on the cultivation of genetically modified plants is unlawful in its current form. This follows a complaint from the American seeds producer Monsanto, as well as other seeds suppliers.
France must now implement the ban on a new legal basis, the judges in Luxembourg have decreed. France has founded the ban to date on the safeguard clause Directive 2001/18/EC.
This is now obsolete, however, and the ECJ has now decreed that only regulation 1829/2003 can provide a valid basis for national GMO bans. As a result, to withdraw plants such as Monsanto's MON810 corn from general use, authorities would have to determine a ‘significant risk’ for humans, animals or the environment. Furthermore, Paris must also inform the Commission in Brussels “as quickly as possible” about any such measures.
Nevertheless, France wants to retain its ban on GMOs. In Paris Environment Minister
Nathalie Kosciusko-Morizet was defiant. “We will again request a safeguard clause, as the environmental problems remain unresolved”, she said. In 2007, on its own initiative, France suspended the use of MON810 seeds, and one year later completely banned production. Just two days prior to the most recent judgment, the ECJ ruled in favour of German beekeepers who had demanded compensation after pollen from a neighbouring GM field trial contaminated their honey. Whole batches had then had to be destroyed.
Biopharmaceuticals: less of a burden on health system than expected
New biopharmaceutical drugs are proving less of a burden for health insurers than was previously feared.
In the past year, the statutory health insurance system (GKV) had to pay less than 10 million euros for such drugs, reported Bertram Häussler from the Berlin IGES Institute during the presentation of the ‘Pharmaceutical Atlas’ on 8 September in the capital. “These drugs are thus acquitted of charges of price fixing in 2010”, said Häussler. His institute has analysed drug consumption through the statutory health insurance together with the German Association of Research-based Pharmaceutical Companies (VFA). In 2010, expenditure increased by 170 million euros. “In the context of a 180 billion-euro market, this is a small amount,” said Häussler. The mandatory rebate, which increased by 16 percent in August 2010, did more than anything to ensure the minor increase – pharmaceutical manufacturers for the GKV vouchsafed about one billion euros more in discounts than in the previous year.
The expert contradicted the assumption that new drugs lead to ever-increasing burdens for the health system: “Increased expenditure on innovation is financed by technical savings. What is meant here is above all the choice of low-cost generics, and appropriate package sizes.” For the statutory health insurance, the financing of new drugs appears to be becoming a zero-sum game. At the event, VFA Chief Executive Birgit Fischer called for better framework conditions for research-based pharmaceutical companies. “I am firmly convinced that the mandatory discount must be revaluated,” she said during the press conference, referring to the multi-billion euro surpluses at the health insurance companies. The Association was also critical about early benefit analysis. If the initial experiences of VFA member companies are to be believed, there are only minimal chances of success in balancing quality of care and cost savings. The head of the Association stressed: “No one wants to impair the quality of care provision for patients in Germany.” Nevertheless, some pharma manufacturers are drawing their own conclusions: Novartis has announced that as of 1 September, it will be withdrawing the blood pressure-lowering combination Rasilamlo from distribution in Germany. Boehringer Ingelheim and Eli Lilly are also unwilling to bring the new diabetes drug Trajenta to the market at a low reimbursement price. Early benefit assessment poses the risk of ‘the therapeutic benefits and positive qualities of Trajenta not being sufficiently taken into account,” went the explanation.
Bayer to expand plant biotechnology arm
Bayer is planning to further stimulate the areas of plant protection and seeds at its Crop Science division with a research offensive.
By 2015, research spending will be doubled to more than 400 million euros, announced Sandra Peterson, head of Bayer CropScience at the annual press conference on 15 September.
Activities in soy, rice and wheat will be strengthened, alongside seeds for cotton, rapeseed, and vegetables – an area in which Bayer has been active for some time already, and in which is it currently seeing major growth. The first new wheat varieties will arrive on the market by 2015, she announced. The corporation is aiming to achieve a turnover of three billion euros by 2020 with seeds, traits, and plant protection solutions for fruit and vegetables. The increased R&D investment is part of a four-pillar strategy, also intended to rejuvenate the plant protection arm of the company. A total of 850 million euros has been set aside for the development of new products by 2015 – 20 percent more than was previously planned.
Older products, such as highly toxic class 1 insecticides, are set to be phased out. These will disappear from the catalogue by the end of 2012. In a recent interview with Dow Jones Deutschland, Crop Science board member Rüdiger Scheitza also raised the prospect of acquisitions: “We will take seriously any opportunities to carry out acquisitions in our area.” The prices for small and medium-sized seed companies available on the market are relatively high, said the manager. These currently lie at two and a half to five times turnover.
Bayer and TU Dortmund build model production line
Pharmaceutical giant Bayer and the Technical University of Dortmund are jointly pursuing the construction of research centre to optimise the production of active pharmaceutical ingredients.
The two partners – Bayer Technology Service and the TU Dortmund – promised to build ‘The factory of the future’ back in 2009 as part of the bid for the F3 project from the European Technology Platform for Sustainable Chemistry (SusChem). The demonstration plant Invite (INnovations, Visions and TEchnologies) has now been opened at the Chempark Leverkusen.
Resource-efficient and flexible production concepts will be tested using a production model in which individual process modules are strung together in ‘container format’. While Bayer will be carrying research results into practical application, the TU is hoping the plant will be advantageous for students; these will be experiencing research at the highest level as part of training and further education courses. “Universities and industry partners can now develop new technologies more efficiently – under proper industrial conditions,” commented Ursula Gather, Rector of the University of Dortmund on the significance of the joint venture between Bayer and the University. The foundation stone for the research building, funded by the Federal Government and the State of North Rhine-Westphalia with five million euros from the second economic stimulus package, was laid on October 2010. A further 6.5 million euros was provided by the University of Dortmund, Bayer, and other public funding. More than 20 people are expected to be employed at the over 800 square-metre laboratory and office space.
Blood test detects serious diseases by the dozen
A German research team has developed a blood test that can quickly detect 14 currently difficult-to-diagnose disorders, including cancer and inflammatory disease.
The test functions on the basis of short RNA snippets, so called microRNAs. In contrast to their larger cousins – the RNAs – these do not serve as a blueprint for specific proteins. Instead, they affect which genes can be read, and determine in a regulatory fashion which proteins are produced.
Because they are involved in many cellular adaptation processes, the researchers hope to employ the microRNAs to uncover specific disease processes. Researchers from the ‘Inflammation Research’ cluster of excellence, which is coordinated by the University of Kiel, have been searching for such changes in the blood of patients suffering from a variety of diseases. They were able to detect microRNAs for 14 diseases, including cancer of the pancreas, the prostate, or the gastrointestinal tract, as well as multiple sclerosis, sarcoidosis, and periodontal disease. Each of these is specific to the respective disease, and can serve as a biomarker. Their results have been presented in the journal Nature Methods (2011, online). “The biomarker microRNAs indicate specific diseases at a stage in which they could previously not be diagnosed”, explained André Franke from the Institute for Clinical Molecular Biology at the University of Kiel. The test has even demonstrated a good hit quality, and could adequately separate the different syndromes. “In the terms of the current tests, this is a very good performance”, said the geneticist. Scientists now hope to diagnose and differentiate a variety of diseases with high reliability using a single blood test. It will be some time until the test will reach maturity, however. “A lot of work, money, and research is required to actually create a marketable product”, thinks Franke.