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GDPR and Biobanking
Part I Setting the scene -- Introduction: Individual rights, the public interest and biobank research 4000 (8) -- Genetic data and privacy protection -- Part II GDPR and European responses -- Biobank governance and the impact of the GDPR on the regulation of biobank research -- Controller' and processor's responsibilities in biobank research under GDPR -- Individual rights in biobank research under GDPR -- Safeguards and derogations relating to processing for archiving purposes in the scientific purposes: Article 89 analysis for biobank research -- A Pan-European analysis of Article 89 implementation and national biobank research regulations -- EEA, Switzerland analysis of GDPR requirements and national biobank research regulations -- Part III National insights in biobank regulatory frameworks -- Selected 10-15 countries for reports: Germany -- Greece -- France -- Finland -- Sweden -- United Kingdom -- Part IV Conclusions -- Reflections on individual rights, the public interest and biobank research, ramifications and ways forward. .
Hurdles for Phage Therapy (PT) to Become a Reality
Alternative treatment modes for antibiotic-resistant bacterial pathogens have become a public health priority. Bacteriophages are bacterial viruses that infect and lyse bacterial cells. Since bacteriophages are frequently bacterial host species-specific and can often also infect antibiotic-resistant bacterial cells, they could represent ideal antimicrobials for fighting the antibiotic resistance crisis. The medical use of bacteriophages has become known as phage therapy. It is widely used in Russia, where phage cocktails are sold in pharmacies as an over-the-counter drug. However, no phage product has been registered for medical purposes outside of the former Soviet Union. The current Specia...
Role of Health Economic Data in Policy Making and Reimbursement of New Medical Technologies
This Research Topic was focused on provision of novel medical technologies worldwide keeping in mind financial sustainability challenge. An exemplary area certainly are oncology pharmaceuticals where prices have increased 10-fold in recent years leading to concerns on affordability. The objective of this collection of studies was to reveal some of the hidden underlying causes of unequal access to the medicines. Another core issue is the growing proportion of out-of-pocket health spending in many world regions. In line with the joint efforts of the editors and authors we received an exceptionally high response worldwide. This E-Book attracted a total of 37 self-standing research submissions o...
Vaccines: Accelerating Innovation and Access
This Global Challenges Report describes the innovation process for vaccines. It explains how the restricted availability of vaccines is due to impediments at every stage of the process. Most of these obstacles are manageable, and intellectual property (IP) rights are associated with only some of them. The analysis aims to put into perspective debates around health innovation and the availability of health technologies in developing countries, especially with respect to the role of IP. In particular, it provides an overview of how IP has been used to meet global health challenges in the vaccines field, and considers whether lessons can be drawn to inform other important health technologies.
Public-Private Partnerships as Drivers of Innovation in Healthcare, 2nd Edition
Multi-stakeholder collaborations involving partners from public and private sectors are essential to address global health challenges and to move precision medicine forward. This eBook assembles a collection of papers which either illustrate recent achievements or discuss new perspectives offered by public-private partnerships in healthcare. Publisher’s note: In this 2nd edition, the following article has been added: Laverty H and Meulien P (2019) The Innovative Medicines Initiative −10 Years of Public-Private Collaboration. Front. Med. 6:275. doi: 10.3389/fmed.2019.00275
Quality Issues in Clinical Genetic Services
Initially genetic disorders were all considered as rare diseases. At present, in the mid of 2009, the OMIM catalogue contains information on more than 12 000 entries of which about 2500 are available for clinical testing based on the identification of the responsible gene defect. However, altogether it has been estimated that about 8 percent of a population in the economically developed countries will during their lifetime suffer from a disease mainly as the result of their genetic constitution. Adding to that, it is estimated that all diseases have a genetic component, which will determine who will be at a higher than average risk for a certain disorder. Further it is postulated that in the...
Artificial intelligence for Drug Discovery and Development
Topic editor Alex Zhavoronkov is the founder of Insilico Medicine, a company specializing in AI research. He is also a professor at the Buck Institute for Research on Aging. All other Topic Editors declare no competing interests with regards to the Research Topic subject.
