The marketing authorisation of an orphan medicinal product is also based on the evaluation of several criteria, including the significant benefit of the product over any available existing alternatives in the Union, in accordance with Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products, which should not be re-assessed in the framework of pricing and reimbursement procedures.

By letter of 8 January 2013, you asked the Committee on Legal Affairs, pursuant to Rule 37 of the Rules of Procedure, to give its opinion on the appropriateness of adding Article 168 to Article 114 TFEU as the legal basis for the proposal for a directive of the European Parliament and of the Council relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems.

29. Urges the Commission is its Review of Directive 89/105/EEC relating to 'the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems' to ensure that this is consistent with the objective of establishing the EU as the home of a globally dominant pharmaceutical industry with the consequent benefits for investment and high-skilled job creation, and particularly to move away from a top-down focus on regulation and pricing that merely discourages competition;

1. The Commission may by Regulation and in accordance with Article 81(3) of the Treaty, declare that Article 81(1) of the Treaty shall not apply to certain categories of agreements between undertakings, decisions of associations of undertakings and concerted practices that have as an object to promote or establish cooperation in the joint operation of maritime transport services between liner shipping companies, for the purpose of rationalising their operations by means of technical, operational or commercial arrangements with the exc ...[+++]eption of price fixing (consortia).

In light of the global nature of the liner shipping industry, the Commission should take the appropriate steps to advance the removal of the price fixing exemption for liner conferences that exist elsewhere whilst maintaining the exemption for operational cooperation between shipping lines grouped in consortia and alliances, in line with the recommendations of the OECD Secretariat in 2002.

The integrated product policy (IPP) strategy focuses on the three stages in the decision-making process which strongly influence the life cycle environmental impacts of products, viz. application of the polluter pays principle in fixing the prices of products, informed consumer choice and eco-design of products.