In the past few years the advances made in biotechnology have been rapid. Newtechniques and applications are appearing in quick succession and growing numbers of biotechnology products are coming onto the market. Moreover, biotechnology is becoming strongly integrated into other research areas and industries,and has become a mainstream technology within the life sciences. These developments offer new opportunities and possibilities for further innovation, economicgrowth, food production and healthcare, but they also have major consequencesfor policy, legislation and how we view biotechnology itself. They raise ethical questions and pose social dilemmas concerning the acceptability and regulation ofnew techniques, property rights and how to deal with differences between national approaches.It is impossible to discuss all the developments in biotechnology in this Trend Analysis. It wastherefore necessary to limit the scope of this analysis to eight trends that are illustrative ofthe field of biotechnology as a whole and that raise important dilemmas and social questionsrequiring political and policy responses.The first two trends – next generation sequencing and CRISPR-Cas – are driving new developments within biotechnology. They give a strong impetus to the other trends discussed inthis report: the development of specific medicines, medical aids and therapies for individuals or specific diseases (personalised medicine, gene therapy, 3D bioprinting), new techniques in agriculture (RNAi), interventions in ecosystems (genetically modified insects),and even the prospect of designing organisms and turning nature to our advantage (synthetic biology)
Medical professionals: The use of some gene therapies, such as replicating viruses, involve not only a risk to the patient (as in all treatments) but also a risk of environmental or third party exposure. For this reason the authorisation procedure includes an environmental risk assessment. For off-label use use of a medicine outside the terms of the licence a new risk assessment has to be made and a new licence applied for, which may conflict with medical interests. A point to consider is raising awareness among doctors and treatment providers of the possible risks of off-label use and the GMO legislation.255,256
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Pharmaceutical companies: Companies face the same issues as for personalised medicine. They will be reminded by government and others that they have a moral obligation not to market gene therapies at excessively high or unrealistic prices. If they do, the government will eventually be forced to intervene. They will have to talk to government and other parties about setting realistic prices and establishing new ways of financing healthcare.
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Government: The challenge facing the government is to amend the legislation to ensure public safety, while removing the unnecessary restrictions on some types of clinical gene therapy research. More gene therapies will soon be coming onto the market and the cost of these therapies will drive up the cost of the healthcare system. A dialogue with the pharmaceutical and gene therapy industry about realistic prices will be needed. An increasing trend will be for people to have treatments in other countries. If returning patients spread viruses or other GMOs, this could lead to possible environmental or public health problems. Such problems could be prevented by establishing a uniform international system for registering patients undergoing gene therapy treatments abroad, but this would run up against privacy and medical confidentiality requirements. Solving these issues will require discussions with health insurers, patient organisations, treatment providers and institutions in oth
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Biotechnology trend Analysis 2016 A regulatory disconnect 57 3.4.5 Conclusions Gene therapy is on the rise. The number of clinical studies is increasing, promising results have been obtained for various disorders, companies are investing in gene therapies and the first products have already come onto the market. New methods and technologies, including the use of replicating viruses to destroy tumour cells, must be subject to a thorough risk assessment, whereas other types of gene therapy involve no risk of the environment or the population being exposed to a GMO. To make full use of the potential of gene therapy to control diseases and support innovation in the Netherlands, the authorisation procedures should be reviewed and, where necessary and possible, amended. In the future the number of gene therapies coming onto the market will increase and the costs of these treatments will be high. A clear system for reimbursing healthcare costs is urgently needed.
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