Locations
ELA Act Deployment Plan
On 10 January, the Ministry of Health and the Ministry of Social Rights and Consumer Affairs met with representatives of ConELA to present a draft plan for the deployment of the ELA Law and to gather their input.
The plan aims to establish a roadmap for the effectiveness of the ELA Law with the purpose of establishing eleven measures to improve the lives of affected people, their families and caregivers. Some of the measures to be implemented in a first phase prior to the approval of the regulation of its scope of application are: the regulatory development of the scope of application, the process of accompanying the autonomous communities to speed up the procedures for access to dependency and disability, the improvement of socio-sanitary coordination and the definition and establishment of aid for travel expenses, among others.
Regulation (EU) 2021/2282 on Health Technology Assessment (HTA)
Since 12 January, Regulation (EU) 2021/2282 on health technology assessment (HTA) has been applicable to all companies applying for marketing authorisation from the European Medicines Agency (EMA).
This regulation establishes a Community framework for the assessment of health technologies, including medicines and medical devices, and aims to help national authorities make more informed and timely decisions on the pricing and reimbursement of health technologies, as well as to streamline the procedure for health technology developers.
The Commission has had in place since 12 January a plan of activities that it has carried out or plans to carry out in preparation for the implementation of the regulation, which is subject to regular updating.
LEGISLATION | The new Medicines Law
Following the leaking of the text of the preliminary draft of the Medicines and Medical Devices Act in December 2024, the Ministry of Health expects to present the regulation to the Council of Ministers between the end of January and the beginning of February.
Although the text of the draft bill leaked in December shows the introduction of relevant changes to the Spanish regulatory framework, we must await confirmation of the final text and the development of its implementation.
Draft Ministerial Order revoking the Order of 24 June 1987 on HIV tests for the procurement, removal, transplantation, grafting or implantation of human organs
The Ministry of Health has opened for hearing and public information the draft Ministerial Order revoking the Order of 24 June 1987 on HIV tests for the procurement, extraction, transplantation, grafting or implantation of human organs.
The increasing need for organs for therapeutic use and improvements in the treatment of HIV infection have led several countries to allow transplantation between HIV-infected people, thus allowing the therapeutic use of organs from HIV-infected donors and bringing the management of risks associated with HIV infection in the field of donation and transplantation in line with that of other infections.
The text of the law aims, among other things, to contribute to the de-stigmatisation of HIV.
The deadline for contributions expires on 5 February.