Creative Techniques in the Framework of Market and Evolution

This paper tries to reframe the man-machine problem, which has frequently changed throughout history. Originally, a machine was a helper of man, but later became its competitor and substitute. As a consequence of this, man has been pushed out of production and possibly, out of life itself. For today, nearly all the man’s functions – except for consumption and creativity – can be furnished by machines. Creativity should have a special place because it is the last “shelter” of man in the conflict with machine. Almost every other faculty of man has more or less been simulated by technology. There are some key questions to be answered: Whom do the creative techniques serve? Is the target group the men or machines

Recommendations from the European Working Group for Value Assessment and Funding Processes in Rare Diseases (ORPH-VAL)

International audienceAbstractRare diseases are an important public health issue with high unmet need. The introduction of the EU Regulation on orphan medicinal products (OMP) has been successful in stimulating investment in the research and development of OMPs. Despite this advancement, patients do not have universal access to these new medicines. There are many factors that affect OMP uptake, but one of the most important is the difficulty of making pricing and reimbursement (P&R) decisions in rare diseases. Until now, there has been little consensus on the most appropriate assessment criteria, perspective or appraisal process. This paper proposes nine principles to help improve the consistency of OMP P&R assessment in Europe and ensure that value assessment, pricing and funding processes reflect the specificities of rare diseases and contribute to both the sustainability of healthcare systems and the sustainability of innovation in this field. These recommendations are the output of the European Working Group for Value Assessment and Funding Processes in Rare Diseases (ORPH-VAL), a collaboration between rare disease experts, patient representatives, academics, health technology assessment (HTA) practitioners, politicians and industry representatives. ORPH-VAL reached its recommendations through careful consideration of existing OMP P&R literature and through a wide consultation with expert stakeholders, including payers, regulators and patients. The principles cover four areas: OMP decision criteria, OMP decision process, OMP sustainable funding systems and European co-ordination. This paper also presents a guide to the core elements of value relevant to OMPs that should be consistently considered in all OMP appraisals. The principles outlined in this paper may be helpful in drawing together an emerging consensus on this topic and identifying areas where consistency in payer approach could be achievable and beneficial. All stakeholders have an obligation to work together to ensure that the promise of OMP’s is realised

Incorporating MCDA into HTA: challenges and potential solutions, with a focus on lower income settings

Background: Multicriteria decision analysis (MCDA) has the potential to bring more structure and transparency to health technology assessment (HTA). The objective of this paper is to highlight key methodological and practical challenges facing the use of MCDA for HTA, with a particular focus on lower and middle-income countries (LMICs), and to highlight potential solutions to these challenges. Methodological challenges: Key lessons from existing applications of MCDA to HTA are summarized, including: that the socio-technical design of the MCDA reflect the local decision problem; the criteria set properties of additive models are understood and applied; and the alternative approaches for estimating opportunity cost, and the challenges with these approaches are understood. Practical challenges: Existing efforts to implement HTA in LMICs suggest a number of lessons that can help overcome the practical challenges facing the implementation of MCDA in LMICs, including: adapting inputs from other settings and from expert opinion; investing in technical capacity; embedding the MCDA in the decision-making process; and ensuring that the MCDA design reflects local cultural and social factors. Conclusion: MCDA has the potential to improve decision making in LMICs. For this potential to be achieved, it is important that the lessons from existing applications of MCDA are learned