The Department is responsible for the transposition of the following European Union legislation into UK law:
Directive 2010/53/EU (Organ transplantation)
Organ Directive 2010/53/EU on standards of quality and safety of human organs intended for transplantation requires transposition by 27 August 2012. The initial total estimated setup cost for the public sector (NHS both centrally and at transplant centres) is £2.758 million, with an ongoing cost over a 10-year period of around £1.605 million per year. Over the same period, the set-up cost for the private sector has been estimated at £300,000 with an annual ongoing cost of £345,000. The Department has recently carried out an external consultation on a proposed implementation approach for the Organ Directive. Cost estimates will be reviewed in light of responses received.
Directive 2011/62/EU (Falsified Medicines)
We plan to implement Directive 2011/62/EU on 2 January 2013. The costs of the implementation of the Falsified Medicines Directive are still to be assessed and assumptions will be included in an impact assessment as part of our consultation process on the directive.
D irective 2010/84/EU (Pharmacovi g il ance)
We plan to implement Directive 2010/84/EU amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use on 21 July 2012. A preliminary assessment of the costs of the directive has been made in a current public consultation. This assessment identifies annual net cost to UK business at £0.8 million (annual costs £4.5 million, annual benefits £3.7 million) and annual cost to the public sector at £2.6 million.
Directive 2011/24/EU (Cross Border healthcare)
We plan to implement Directive 2011/24/EU on Cross Border Healthcare allowing EU citizens to seek planned healthcare treatment in other EU member states on 25 October 2013. Associated costs have not yet been estimated, and will be included in an impact assessment as part of the Department of Health consultation process planned for the summer of 2012.