Local view for "http://purl.org/linkedpolitics/eu/plenary/2011-02-02-Speech-3-274-000"
| Predicate | Value (sorted: default) |
|---|---|
| rdf:type | |
| dcterms:Date | |
| dcterms:Is Part Of | |
| dcterms:Language | |
| lpv:document identification number |
"en.20110202.19.3-274-000"2
|
| lpv:hasSubsequent | |
| lpv:speaker | |
| lpv:translated text |
"In 2008, the Tuberculosis Vaccine Initiative (TBVI) was established in the form of a public-private partnership with the support of the Health Cooperation Programme within the Seventh Framework Programme for research in order to mobilise additional resources for this important area.
At the present time, the majority of recently developed new vaccine candidates are still in the preclinical development phase or beginning clinical development. A crucial point to emphasise is the fact that we do not have available clinical data to support the idea that one of the vaccine candidates under development could prove to be more effective than the vaccine currently in use, which is the Bacillus Calmette-Guérin (BCG) vaccine.
In order to come onto the market, new vaccine candidates must be capable of being more effective than BCG or of replacing it as a better vaccine. The fact is that we still do not have these important data available. The TBVI should not be considered in isolation from other initiatives for supporting clinical trials.
In order to deal with bottlenecks in the clinical development field, the European and Developing Countries Clinical Trials Partnership, or EDCTP, has been established as the first initiative taken under Article 185, in which 14 Member States, 2 Associated States and the Commission have collectively committed EUR 400 million, with EUR 200 million coming from the European Union, with the aim of promoting research in phase 2 or 3 clinical trials for AIDS, for example, malaria and tuberculosis in sub-Saharan Africa. The programme is predicted to complete all the trials currently under way, including eight trials of the anti-tuberculosis vaccine, by 2015. This alternative is therefore already in place, and it works. The Commission is also very interested in what is called ‘the business model’, which has been developed by the public-private partnerships, including the one presented by the TBVI.
The TBVI has, moreover, proposed a model that can potentially become a useful tool in the future. However, this requires an in-depth analysis of the commercial project as well as a risk assessment. Consequently, even if the TBVI enjoys significant financial support, its success is not guaranteed, precisely because of the fact that there is not enough information to indicate whether what is currently being trialled can yield results subsequently.
However, the Commission will continue these internal discussions and will also analyse the model with the financial institutions, thus contributing to the development of a concept so that it can form part of the practical implementation of EU 2020. From this point of view, then, this possibility could be examined."@en1
|
| lpv:videoURI |
Named graphs describing this resource:
The resource appears as object in 2 triples