20 Amendments of Andris AMERIKS related to 2020/2071(INI)
Amendment 5 #
Draft opinion
Recital A
Recital A
A. whereas the problem of medicine shortages in the Member States is gettrowing ever more severe on account ofdue the lack of production capacity in the EU and the relocation of our industries in the sector to other markets in third countries;
Amendment 10 #
Draft opinion
Recital A a (new)
Recital A a (new)
A a. whereas uncoordinated initiatives at national level, such as stockpiling and penalties, could lead to an increased risk of medicines shortage, while a pan- European coordinated approach and a close dialogue among all actors concerned is crucial to mitigate and prevent medicines shortage, as the covid- 19 crisis has demonstrated;
Amendment 10 #
Draft opinion
Recital B
Recital B
B. whereas transport and logistics management are of crucial importance for the supply of medicine, pharmaceutical products, medical equipment, personal protective equipment, other medical supplies and raw materials, not least given the increasing degree of complexity of the transport chain, and whereas it is important to have efficient crossing green lane borders with fast track lanes in order to ensure the unobstructed flow of medicines;
Amendment 20 #
Draft opinion
Recital A b (new)
Recital A b (new)
A b. Whereas is fundamental to prevent medicine shortages, as well as to mitigate them in case they occur; shortages of medicines are a symptom of unsustainable policies, abundant scientific evidence demonstrates that medicines shortages have numerous root causes: specifically economic causes, increasing regulatory burden, unforeseen surges in demand, supply chain interdependencies and manufacturing and quality challenges;
Amendment 29 #
Draft opinion
Recital A c (new)
Recital A c (new)
A c. Whereas after the pandemic a global economic crisis is expected, this will challenge even more equitable access to medicines and competitiveness of industrial sector;
Amendment 31 #
Draft opinion
Paragraph 1
Paragraph 1
1. Calls on the Member States to enhance theirComission to coordinate with Member States a strategy for a cooperation in order to improve the distribution chain through better visibility and efficient monitoring, particularly on cross-border routes, and to establish corridors where medical supplies have priority of delivery;
Amendment 41 #
Draft opinion
Paragraph 2
Paragraph 2
2. Stresses that boosting the industrial production of the Member States through favourable economic conditions in the context of national fiscal policie, social and environmental conditions would lead to a more efficient and sustainable logistics network, while reducing the length of transport routes, thereby reducing emissions, mitigating the impact on the environment, and improving the functioning of the internal market;
Amendment 45 #
Draft opinion
Paragraph 3
Paragraph 3
3. Calls on the Commission to work in coordination with the Member States in order to adopt strategic plans to upgrade their existing infrastructure for an efficient supply of medicines with a better use of all transport modes; deems it necessary to remove bottlenecks, boost intermodality (while favouring the shift to rail), finance the main hubs (ports, airports and intermodal platforms), and enhance the delivery of various types of goods, including dangerous goods crucial for the production of the chemical and pharmaceutical industry;
Amendment 52 #
Draft opinion
Paragraph 4
Paragraph 4
4. Highlights the importance of IT systems in facilitating the exchange of information between the various actors involved in the transport logistics chain, including the customs authorities, with a view to optimising the distribution of medicines in the Member States and planning supply times more efficiently; calls on the Commission to develop mechanisms in cooperation with Member States in order to ensure a fast and safe transport of medicines; notes also the importance of having contingency plans that ensure the unobstructed transport of medicines when the transport sector is conditioned;
Amendment 53 #
Draft opinion
Paragraph 1
Paragraph 1
1. Insists that the Commission urgently launches a multi-stakeholder consultation to identify keyevidence-based drivers within the supply chain issuesand beyond that directly cause or increase the risk of medicine shortages; calls on the Commission to propose ambitious and concrete actions to address these issues in its planned pharmaceutical strategy;
Amendment 56 #
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. Calls on the Commission to coordinate a Pan-European response, with European Medicines Agency (EMA), National Competent Authorities (NCAs), Member States, the pharmaceutical industry and all players in the pharmaceutical supply chain; a coordinated EU response is of utmost importance to coordinate Members States policy measures to individual and uncoordinated national measures to address medicines shortages root causes and prevent them in the long term as well as to ensure the right of patients to universal, equitable, affordable, effective, safe and timely access to essential medicines, as well as to guarantee the sustainability of the EU public healthcare systems;
Amendment 67 #
Draft opinion
Paragraph 6
Paragraph 6
6. Stresses the importance of catering to specific transport needs at local and regional levels, particularly in rural, mountain and insular, insular and outermost regions areas that are more difficult to access and involve higher delivery costs; notes that there are new automated delivery tools, such as via drones, available on the market that could help operators to access these areas;
Amendment 70 #
Draft opinion
Paragraph 2
Paragraph 2
2. Calls on the Commission to consider proposing requirements for the pharmaceutical industry to ensure that its supply chain is diversified andincentivize the pharmaceutical industry to put in place a medicine shortage risk mitigation plan for essential medicines to manage any vulnerabilities in and risks to the supply chain;
Amendment 71 #
Draft opinion
Paragraph 7
Paragraph 7
7. Notes that the COVID-19 outbreak has laid bare the weaknesses of the European production system,is highlighting the importance of delivering medicines swiftly in urgent and exceptional circumstances that could arise in the future; calls on the European Commission to prepare an agreement with drug- producing third countries, to ensure the transport of medicines overcoming any constraints that may occur, such as this case of the COVID pandemic.
Amendment 74 #
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2 a. Calls on the Commission to preserve a competitive research-based pharmaceutical industry taking into account that EU remains by far the world leader manufacturing region of active ingredients for on patent medicines;
Amendment 103 #
4. Encourages the Commission to propose measures, including financial incentives, to promote investments in green manufacturing for medicines value chain, within the EU, of strategically important chemicals used in medicine production; urges the Commission to also propose measures to incentivise the greater inclusion of EU small and medium-sized enterprises in the medicine supply chain given their key role in research and innovation and inherent ability to quickly adapt their production focus, with a view to coping better with unexpected shocks;
Amendment 109 #
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Underlines that ensuring a fit for purpose regulatory environment is a key element to protect public health, provide access to high quality medicines and contribute to the prevention of shortages. The adequate use of Information Technology systems will improve regulatory efficiency across Europe; therefore, the Commission should optimize the European regulatory framework by harmonising regulatory telematics projects with a focus on data quality, interoperability and interdependency;
Amendment 129 #
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. In order to support Member States in the prevention of medicine shortages, calls on the Commission to develop targeted EU Guidelines on procurement of medicines by putting in place the right economic framework, under the EU public procurement Directive 2014/24/EU, aimed at ensuring long term sustainability, competition, security of supply and stimulating investments in manufacturing;
Amendment 135 #
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
Amendment 147 #
Draft opinion
Paragraph 5 c (new)
Paragraph 5 c (new)
5 c. Calls on the Commission and relevant authorities, in the mitigation of shortages of medicines, when they occur, to provide regulatory flexibility by allowing targeted measures such as more flexibility for multi-language packs, different pack size and e-leaflet, to ensure that patients are able to access high- quality and safe medicines faster;