Media and Political Bulletin – 03 August 2020
Media and Political Bulletin
03 August 2020
New Europe, Alessandra Moretti, 03 August 2020
Italian MEP and member of the European Parliament Committee on the Environment, Public Health and Food Safety (ENVI), Alessandra Moretti, writes in New Europe that the Committee approved the July 14 NI Report on the shortage of medicines.
The report reaffirms the need to address the root causes of medicines shortages and calls for a more impactful EU response to face this very complex issue. All the main political groups have agreed that this problem cannot be solved by individual actions at the national level, and thus that a more coordinated initiative from EU authorities will be required.
The approved text further highlights that “no Member State is self-sufficient with regard to raw materials, intermediates, active pharmaceutical ingredients (APIs) and finished medicines that are necessary to guarantee the proper functioning of the health system.”
The report also highlights the need for national authorities and the private sector to also be held responsible. Finally, Moretti points to the request for shortage prevention and risk management plans to be prepared by relevant actors in order to better prepare for a possible risk of shortages, particularly for those medicines for which no alternative exists at the moment.
On 28 July 2020, the European Union Committee convened virtually to discuss the Protocol on Ireland/Northern Ireland. The Committee heard evidence from Robin Walker MP, Minister of State, Northern Ireland Office on the measures being taken to prepare for the implementation of the Protocol.
The full virtual meeting can be accessed here.
New Europe, Alessandra Moretti, 03 August 2020
The July 14 NI Report on the shortage of medicines was approved by the ENVI Committee in the European Parliament, addressing the root causes of medicine shortages and calling for appropriate responses on different levels. Unfortunately, there are still too many patients in Europe that cannot access treatment because the drugs they need are not available. Therefore, an EU wide response has been long-awaited by patients, researchers, doctors, and the private sector.
The report was the result of intense and very delicate negotiations among different political groups, which was also complicated by a very tight timeline. Overall, the text is a balanced and comprehensive call by the European Parliament to address this very sensitive issue.
In general terms, some important results have been included in this dossier, including the reaffirmed right to healthcare for everyone, strengthening of the role of the European agencies responsible for public health, and the confirmation of the fundamental role of research and innovation.
More specifically, on shortages, the report reaffirms the need to address the root causes of medicines shortages and calls for a more impactful EU response to face this very complex issue. All the main political groups have agreed from the beginning that this problem cannot be solved by individual actions at the national level, and thus a more coordinated initiative from EU authorities will be required.
In recent years, it has been clear that “no Member State is self-sufficient with regard to raw materials, intermediates, active pharmaceutical ingredients (APIs) and finished medicines that are necessary to guarantee the proper functioning of the health system”, as can be read in the text that was just approved. Therefore, EU action is needed to restore European independence in terms of medicines and treatment, by, for example, bringing back the production of many APIs for which the EU is now dependent on the strategic choices of other countries with the objective of making medicines available, affordable, sustainable, and equally accessible to everyone in the EU, regardless of their country of residence.
In order to do so, the keyword in this report is responsibility. Responsibility for national authorities, which must provide an efficient regulatory environment and plan ahead in terms of preventing deficiencies. The report demands that the Commission and the EMA have an enhanced coordination role, with precise powers, a broader mandate, and enhanced staff.
At the same time, the report states clearly the responsibility of the private sector. which must do its part, and do it better. Pharmaceutical companies, market authorisation holders, and wholesale distributors have a fundamental responsibility to the proper functioning of the supply chain. While recalling the importance of the provisions included in the Directive 2001/83, the report criticises the “disparities observed by the Commission in the transposition of these obligations into national legislation” and calls on the Commission to make sure that market authorisation holders and wholesale distributors comply with the requirements of the directive to ensure appropriate and continued supplies of medicines, while also asking for “dissuasive and proportionate sanctions in case of non-compliance”.
Another very important point is the request for shortage prevention and risk management plans to be prepared by the relevant actors in order to better prepare for a possible risk of shortages, particularly for those medicines for which no alternative exists at the moment.
The activation of emergency plans, which can act as a rapid and timely alert tool on the shortage risk – either current or potential – of certain drugs, could be useful in order to limit as much as possible deficiencies. These plans could help provide a constantly updated picture of the availability of certain medicines in Europe and could be vital for the public authorities to foresee timely intervention in case of possible shortage risks.
Moreover, the report asks for the issue of storage at Member State level to be addressed at EU level. We cannot allow the Member States to move freely on such a sensitive issue, without coordination and perhaps by competing with each other, and this was included in the text.
To conclude, we know, unfortunately, that medicine shortages have a direct impact on patients’ health, on their safety, the continuation of their treatment and their life expectancy, placing the lives of too many people in Europe at risk.
Medicine shortages have been affecting EU citizens’ health for too long already, but the COVID crisis has sharpened the hardship on this. The recent crisis has demonstrated again the importance of a strong Europe able to protect its citizens, even in healthcare.
In this sense, the Socialist & Democrats Group has proposed a comprehensive plan for the creation of a genuine European Health Union, a plan that would enhance UE ability to protect its citizens also in health matters. This is for us the final objective, but we can consider this first report on shortages as a first concrete step in the right direction to build a safer and fairer Europe for everyone.
From Factory to Pharmacy
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