Chapter 5 - Regulation and control of drugs: Between prescriptive appriopriateness and limitation of public spending towards the goal of deregulating the pharmaceutical market

Article type: Research Article

Authors: Agnello, Carmen

Affiliations: Catania, Italy . E-mail: agnello.carmen@libero.it

Abstract: This article allows toanalyze drug testing from the standpoint of prescriptive appropriateness, as a tool and a resource to implement a welfare state system, in which the NHS provides an equitable access to innovative pharmaceutical treatments that might cause clinical benefits. In pursuing these interests it is necessary to ensure the due interaction between the economic and the legal profile. This implies the need of analyzing and balancing risks and benefits of experimental treatments with the objective of lowering health care costs for state budgetary purposes. In this respect, both economic process trends and social dynamics will bedealt with, given their link with market globalization, as well as compensatory measures, tax reliefs and settlements designed to streamline and reduce public spending in this area. - As far as the latter aspect is concerned, the international regulatory framework will be taken into account at a global and a local level, in the perspective of the European and the national level, by highlighting the positive and negative aspects of systems integration and of public intervention in favour of society health. - A special profile that will be analyzed is related to testing of innovative treatments and to the expansion of production and sales of new drugs also in developing countries while facing pandemic situations. In this regard, the attention will be addressed to the role of Health Technology Assessment (HTA), as a tool for health policy in support of technological innovation and the use of off label drugs, in light of interchangeability, aimed at ensuring more prescription appropriateness and economic advantage. Several issues concerning orphan drugs and to compassionate use will deserve a special focus too. The exemplary case of Stamina will be examined, being one of the most revealing one in highlighting both gaps and limitations of internal regulations, in recent times. - In order to ensure a balance between the interests involved and guarantee the access of innovative medicines, while maintaining the accuracy and safety of the experiments, as well as balance the state budget, we will try to expose a path over the forming Legal Department, able to fully assess and implement the most appropriate measures to optimize and most appropriate functionalization of health care to an equitable distribution of resources and the burden on the community. In a de jure perspective flavoring we will try to identify any areas to bridge the gaps and to overcome the weaknesses in the regulatory level.

DOI: 10.3233/PPL-160421

Journal: Pharmaceuticals Policy and Law, vol. 17, no. 3-4, pp. 373-408, 2015