8 Amendments of Jan HUITEMA related to 2020/0321(COD)
Amendment 119 #
Proposal for a regulation
Recital 2
Recital 2
(2) The unprecedented experience of the COVID-19 pandemic has demonstrated that the Union should be more effective in managing the availability of medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public health from an early stage and in coordination with the national authorities, the industry and other entities of the pharmaceutical supply chain. The Union’s ability to do so has been severely impeded by the absence of a clearly defined legal framework for managing its response to the pandemic, and also by the limited degree of Union preparedness in case of a public health emergency impacting a majority of Member States.
Amendment 133 #
Proposal for a regulation
Recital 4
Recital 4
(4) Dealing with tThe issue of shortages of medicinal products has been a long- standing and insufficiently addressed priority for the Member States and European Parliament as illustrated by several reports from the European Parliament11 as well as discussions under recent Presidencies of the Council of the European Union. _________________ 11European Parliament resolution of 17 September 2020 on the shortage of medicines – how to address an emerging problem (2020/2071(INI))
Amendment 153 #
Proposal for a regulation
Recital 7
Recital 7
(7) Uncertainty of supply and demand and the risk of shortages of essential medicinal products and medical devices during a public health emergency like the COVID-19 pandemic can trigger export restrictions amongst Member States and other national protective measures, which can seriously impact the functioning of the internal market. Furthermore, shortages of medicinal products can result in serious risks to the health of patients in the Union due to their lack of availability, which can cause, medication errors, increased duration of hospital stays, and adverse reactions caused by the administration of unsuitable products used as a substitute for unavailable ones. With respect to medical devices, shortages can lead to a lack of diagnostic resources with negative consequences for public health measures, a lack of treatment or deterioration of the disease and may also prevent health professionals from adequately carrying out their tasks. Those shortages can also have a significant impact on controlling the spread of a given pathogen caused by, for example, an insufficient supply of COVID- 19 test kits. It is therefore important to address the question of shortages and to reinforce and formalise monitoring of critical medicinal products and medical devices in the most efficient way and so as to avoid creating unnecessary burdens for stakeholders which may strain resources and cause additional delays.
Amendment 167 #
Proposal for a regulation
Recital 10
Recital 10
(10) In order to ensure a better functioning of the internal market of those products and contribute to a high level of human health protection, it is therefore appropriate to approximate the rules on monitoring of shortages of medicinal products and medical devices, and to facilitate the research and development of medicinal products, which may have the potential to treat, prevent, or diagnose diseases that cause public health crises, with a view to strategically complement the efforts of the Commission and other existing Agencies to that end, as well as that of future key agencies such as the proposed European Health Emergency Preparedness and Response Authority (HERA).
Amendment 223 #
Proposal for a regulation
Recital 27
Recital 27
(27) During a public health emergency or in relation to a major event, the Agency should ensure cooperation with the European Centre for Disease Prevention and Control and other Union Agencies as appropriate. Such cooperation should include data sharing, including data on epidemiological forecasting, regular communication at an executive level, and invitations to representatives of the European Centre for Disease Prevention and Control and other Union Agencies to attend meetings of the Emergency Task Force, the Medicines Steering Group, and the Medical Devices Steering Group, as appropriate. This cooperation should also include strategic discussions with relevant entities of the Union in a position to boost the research and development of appropriate solutions and technologies to mitigate the effects of the public health emergency or major event, or prevent future similar public health emergencies or major events, such as the proposed European Health Emergency Preparedness and Response Authority (HERA).
Amendment 227 #
Proposal for a regulation
Recital 29
Recital 29
(29) In order to ensure that sufficient resources, including appropriate staffing and adequate expertise, are available for the work provided for under this Regulation, expenditure of the Agency should be covered by the contribution from the Union to the Agency’s revenue.
Amendment 490 #
Proposal for a regulation
Article 9 – paragraph 3 – point h
Article 9 – paragraph 3 – point h
Amendment 592 #
Proposal for a regulation
Article 15 – paragraph 5 a (new)
Article 15 – paragraph 5 a (new)
5 a. Where a clinical trial reviewed as part of an accelerated scientific advice process is authorised, the developer of the clinical trial shall: (a) publish the study protocol at the start of the trial through the European Union clinical trials register; (b) publish the summary of the results of the trial through the European Union clinical trials register by a deadline set by the Agency shorter than that laid down in Article 37 of Regulation (EU) No 536/2014, taking into consideration the public interest and nature of the health emergency.