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17.3.7.  EU policy in various industrial sectors

    In addition to the sectors examined above, the European Union is incidentally interested in certain sectors such as the motor vehicle industry or the chemicals industry, in particular as regards the functioning of the internal market, the encouragement of intangible investment in research and development and the coordinated approach of their problems vis-à-vis the outside.

    Thus, in the automobile industry, the European type-approval system for vehicles is designed to help to lower makers' costs, while maintaining identical technical specifications and a high level of protection of motorists and pedestrians throughout the European Union [Directive 2007/46, last amended by Regulation 2015/758 and Regulation 715/2007]. The approximation of the laws of the Member States aims to increase the safety of motor-vehicles, concerning in particular, safety belts, seats, their anchorages and head restraints [Regulation 661/2009, last amended by Regulation 2016/1004]. The Regulation on the application of Article 101 § 3 of the TFEU (ex Article 81 § 3 TFUE) of the Treaty to categories of vertical agreements and concerted practices [see section 15.3.3] in the motor vehicle sector is meant to increase competition and bring tangible benefits to European consumers as regards vehicle sales and after-sales servicing [Regulation 461/2010 and Commission guidelines].

    In the pharmaceutical industry, the free movement of its products in the common market has long been pursued by the harmonisation of legislations and regulations monitoring their marketing. Nowadays this is done by the European authorisation system for medicinal products for human and veterinary use, preventing, inter alia, the entry into the legal supply chain of falsified medicinal products [Directive 2001/83 last amended by Regulation 2017/745 and Regulation 726/2004]. The authorisation can be given either by a centralised or a decentralised procedure. Under the centralised procedure, applications for marketing authorisations are submitted to the European Medicines Agency, which conducts the scientific evaluation of the application and gives its opinion to the Commission, which adopts a decision, subject to endorsement by a committee of representatives of the Member States. The marketing authorisation obtained at the end of this procedure is valid throughout the European Union. Under the decentralised procedure, the pharmaceuticals company concerned asks one or more Member States to recognise the marketing authorisation issued by another Member State.

    Biotechnology, i.e. genetic engineering, which makes it possible to obtain new chemical, pharmaceutical or food products and highly competitive processes in a large number of industrial and agricultural activities, is mainly developed in the pharmaceutical industry. Indeed, two thirds of the new medicines undergoing clinical trials are derived from modern biotechnology. Also preponderant in enzyme production, biotechnology can provide important energy (fuel) and industrial outlets for agricultural raw materials. It should be noted that, while reinforcing European competitiveness, EC/EU legislation endeavours to ensure the protection of both human health by a contained use of genetically modified micro-organisms [Directive 2009/41] and the environment by a deliberate release of genetically modified organisms [see section 11.2]. The EC/EU has concluded the Cartagena Protocol on Biosafety to the Convention on Biological Diversity [Protocol and Decision 2002/628].

    Stressing the strategic importance of the life sciences and biotechnology sector, as well as the ethical issues involved, and pointing out its potential in many fields such as healthcare, agriculture, food, industry and the environment, the Commission is proposing a strategy aimed at helping Europe to master the frontier technologies. This strategy, supplemented by an action plan with recommendations to the Member States, local authorities, industry and all interested parties, is based on several lines of action; notably: harvesting the potential of this sector, in particular by reinforcing the scientific resource base; and a responsible policy with regard to life sciences and biotechnology, the preparation, implementation and monitoring of which should be based on a regular dialogue with the general public and all the stakeholders, as well as scientific data, and should respect the fundamental values and regulatory principles of the EU (e.g. the precautionary principle, safeguarding the internal market and providing consumer information) [COM/2002/27]. In conclusions adopted on 6 June 2002, the Council considered that the Commission's communication constituted a useful basis for a balanced, coherent and effective framework necessary to enable the EU to exploit the full potential of biotechnology, while taking account of societal values and concerns.

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    Your roadmap in the maze of the European Union.

    Based on the book of Nicholas Moussis:
    Access to European Union law, economics, policies

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