Publications by authors named "Luis Collia"
Gene therapy orphan medicinal products constitute a unique group of new drugs which in case of hereditary diseases are usually administered only once at an early age, in the hope to provide sufficient gene product to last for the entire life of the patients. The combination of an exceptionally large single payment and the life-long clinical follow-up needed for understanding the long-term benefits and safety of gene therapy, represent new types of scientific, financial, social and ethical challenges for the pharmaceutical industry, regulators and society. With special consideration of the uniqueness and importance of gene therapy, the authors propose a three points plan for a close cooperation between the pharmaceutical industry and society to develop orphan gene therapy.
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- The expansion of data-driven research in the 21st century has identified gaps in the existing ethical frameworks for research, particularly in the use of secondary data.
- The World Medical Association's Declaration of Helsinki, which outlines ethical principles for medical research, was last updated in 2013, and the Declaration of Taipei was introduced in 2016 to address health databases and biobanks.
- The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine recommends enhancing the connection between these two declarations to better support data-driven research and protect participants' rights.
The complexity of developing and applying increasingly sophisticated new medicinal products has led to the participation of many non-medically qualified scientists in multi-disciplinary non-clinical and clinical drug development teams world-wide. In this introductory paper to the "IFAPP International Ethics Framework for Pharmaceutical Physicians and Medicines Development Scientists" it is argued that all members of such multidisciplinary teams must share the scientific and ethical responsibilities since they all influence directly or indirectly both the outcome of the various phases of the medicines development projects and the safety of the research subjects involved. The participating medical practitioner retains the overriding responsibility and the final decision to stop a trial if the well-being of the research subjects is seriously endangered.
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