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EU General Data Protection Regulation (GDPR) replaces the Data Protection Directive 95/46/EC and was designed to harmonise data privacy laws across Europe, to protect and empower all EU citizens data privacy, and to reshape the way organisations across the region approach data privacy. The final Regulation provides more rights to citizens to be better informed about the use made of their personal data, and gives clearer responsibilities to people and entities using personal data.
GDPR covers patients™ fundamental right to protection of their health data and is an important issue in diverse contexts such as healthcare, including care given through eHealth or in a cross-border healthcare context, and research (clinical trials, clinical investigations, epidemiological research, patient registries, etc). Health and genetic data belong to the category of sensitive data™, and benefit from additional protection.
Refer to Regulation (EU) 2016/679 for more information.
A gene mutation is a permanent alteration in the DNA sequence that makes up a gene. Mutations range in size, affecting from a single DNA building block (base pair) to a large segment of a chromosome with multiple genes. Gene mutations can be classified in two ways:
Gene therapy is an experimental technique that replaces a faulty gene in a cell, or adds a new gene to cure or prevent disease. In the future, this technique may allow doctors to treat a disorder instead of using medicines or surgery. Researchers are testing several approaches to gene therapy, including replacing a mutated gene that causes disease, deactivating a mutated gene that is not properly functioning, or introducing a new gene into the body to help fight a disease.
Although gene therapy is a promising treatment option for a number of diseases, the technique is still under study to make sure that it will be safe and effective. Gene therapy is currently only being tested for the treatment of diseases that have no other cures.
Gene Therapy Advisory Committee
Gene Therapy Advisory Committee
A generic medicine is a medicine that is developed to be the same as a medicine that has already been authorised, called the 'reference medicine'.
A generic medicine contains the same active substances as the reference medicine, and it is used at the same doses to treat the same diseases. However, a generic medicine's inactive ingredients, name, appearance, and packaging can be different from the reference medicine's.
Generic medicines are manufactured according to the same quality standards as all other medicines.
A company can only develop a generic medicine for marketing once the period of exclusivity on the reference medicine has expired. This is usually 10 years from the date of first authorisation.
Each medicine has an approved name called the generic name. A group of medicines that have similar actions often have similar-sounding generic names. For example, phenoxymethylpenicillin, ampicillin, amoxicillin, and flucloxacillin are in the same group of antibiotics.
Genetically Modified Organism
A genetically modified organism (GMO) is an organism whose genetic material has been altered in the laboratory. Genetic modifications are made to produce certain traits (such as disease resistance in crops) or to cause the organism to produce specific biological products (for example, bacteria have been altered in order to produce insulin for diabetes treatment, and plants have been altered to make antibodies and blood-clotting factors).
GMOs are used in the production of medicines, and in new forms of medicines such as gene therapy.
Genetic modification is also a useful tool for scientists in many areas of research, including those who study the mechanisms of human and other diseases.
The genome is an organism™s complete set of genetic instructions. Each genome contains all of the information needed to build that organism and allow it to grow and develop. The genome includes both the genes and the non-coding sequences of the DNA/RNA. The human genome contains about 35,000 genes.
The Human Genome Project, completed in 2003, was an international effort to identify all the genes in human DNA, and to determine the sequences of the 3 billion base pairs of DNA. It took 13 years.
Genome research has helped diagnose diseases and find genetic markers for certain diseases.
Genome-wide association study
Genome-wide inferred study