The EU is supporting local governments to achieve common objectives, pool resources and overcome shared challenges. In addition, measures are being taken to fight the COVID-19 pandemic.
We highlight below what the European institutions have been working on to date:
17 July, Ministry of Health: “Early response plan in a COVID-19 pandemic control scenario“.
The Inter-Territorial Council of the National Health System (SNS), of which the Ministry of Health and the Autonomous Communities are members, has approved the “Early Response Plan in a COVID-19 pandemic control scenario”.
This is a document intended to provide the National Health System with greater capacity to prevent and tackle possible increases in COVID transmission.19 It has been agreed that the Plan will be revised when necessary. The document incorporates improvements and technical specifications, at the proposal of the Autonomous Communities, different ministries and the Warning and Preparedness and Response Plans Committee, which reports to the Public Health Commission.
The Plan also establishes responses by specific scenarios, such as that of prisons. Given the special characteristics of these centres and the close contact of people with chronic pathologies, the appearance of a coronavirus outbreak could be a serious problem.
Therefore, the Plan recommends following the updates of the recommendations proposed by the health authorities. Prisons should collaborate in the collection, verification and reporting of data in order to be able to plan and intervene appropriately. It is also recommended that reinforced surveillance systems be adopted in these environments and that they should have contingency plans adapted to the specific characteristics of each centre.
On the other hand, the Plan establishes specific measures for groups that are particularly vulnerable to the COVID, such as migrants who enter our country illegally. Specific measures will be adopted for the early diagnosis of these people.
15 July, European Commission: Commission reinforces preparation for future outbreaks
The Commission has presented immediate short-term measures to strengthen EU health preparedness for COVID-19 outbreaks. A continued vigilance and fast response from the Commission and the Member States is essential to ensure that the spread of the virus can be contained and new, generalised lockdowns can be avoided.
The communication lays out a number of priority actions for national authorities, the Commission and EU Agencies:
- Increased testing coverage, contact tracing and surveillance by public health bodies to map clusters in order to contain the spread of outbreaks. In addition to the Communication, the Commission adopted today an Implementing Decision to support interoperability of mobile tracing and warning apps across national borders in the EU.
- Ensuring the smooth supply of personal protective equipment, medicines and medical devices through mechanisms such as emergency joint procurements and strategic EU stockpiles.
- Maintaining rapid access to public health surge capacities without neglecting other areas of healthcare, including through financial support for the transport of medical personnel and patients between Member States and the coordination of the deployment of emergency medical teams and equipment to requesting countries through the EU Civil Protection Mechanism.
- Provision of targeted and localised non-pharmaceutical measures, informed by research and evidence as well as timely information exchange on the effectiveness of re-introduced measures.
- Supporting vulnerable groups such as the elderly, those with underlying medical conditions and those on the margins of society through sharing best practices of testing, care, and treatment, including in mental health and psychosocial support.
- Reducing the burden of seasonal flu to avoid additional pressure on the already-stretched health care systems, through increased vaccination coverage and other means such as ensuring additional national procurements for influenza vaccines.
15 July, European Parliament: EU must step up efforts to tackle medicine shortage
In a report on the shortage of medicines, adopted by 79 votes to 1 with 0 abstentions, the Committee on the Environment, Public Health and Food Safety addresses the root causes of the shortage of medicines. It stresses the need for a greater EU response, as the problem has been exacerbated by the COVID-19 health crisis across Europe, with a direct negative impact on patient health and safety and on the continuation of treatment.
The report calls on the Commission to use the forthcoming pharmaceutical strategy to address the issue of availability, accessibility and affordability of safe medicines in Europe.
- Return to EU independence in the health sector: MEPs call on the Commission to find ways to restore pharmaceutical manufacturing in Europe, giving priority to essential and strategic medicines, as currently 40% of medicines marketed in the EU come from non-EU countries, while 60-80% of active pharmaceutical ingredients are produced in China and India. MEPs encourage the introduction of financial incentives to persuade producers to manufacture active pharmaceutical ingredients and medicines in Europe. They also welcome the new EU health programme EU4Health to make medicines and medical equipment more available and accessible.
- Better coordination with and between EU countries: The report calls on Member States to share best practices in stock management and to create coordinated health strategies, including greater use of joint EU procurement of medicines. It also calls on the Commission to set up a European contingency stock of medicines of strategic importance along the lines of the RescEU mechanism. This reserve should function as a European emergency pharmacy’ in order to minimise shortages. Equal access for all Member States must be guaranteed through a new fair distribution mechanism.
14 July, European Commission: commitments offered by Aspen to reduce prices for six off-patent cancer medicines by 73%
The European Commission invites all interested parties to comment on the undertakings offered by Aspen to meet the Commission’s concerns about excessive pricing. Aspen proposes to reduce its prices in Europe for six critical cancer drugs by 73% on average. In addition, Aspen proposes to guarantee the continuous supply of these off-patent medicines for a significant period
Aspen is a global pharmaceutical company based in South Africa with several subsidiaries in the EEA. Following an official investigation launched on 15 May 2017, the Commission has serious concerns that Aspen has been abusing its dominant position in many national markets by charging excessive prices for critical cancer drugs without patent protection. After acquiring the cancer drugs from another company, Aspen started to increase its prices in Estonia, Germany, Latvia, Lithuania, Poland, Sweden and the United Kingdom in 2012 and then applied the same strategy in all other countries in Europe where Aspen sold the drugs.
- The proposed commitments:
Aspen has offered the following commitments to address the Commission’s competition concerns:
(a) Aspen will reduce its prices across Europe for the six cancer drugs by an average of approximately 73 per cent;
(b) These prices will be the maximum that Aspen can charge over the next ten years. They will take effect already from October 2019; and
c) Aspen guarantees the supply of the medicines for the next five years and, for an additional period of five years, will continue to supply or make its marketing authorization available to other suppliers.
10 July, European Parliament: Parliament supports facilitation of development of COVID-19 vaccines
The EP supported a temporary derogation from the rules on clinical trials to facilitate the development, authorisation and availability of safe vaccines for COVID-19. With 505 votes in favour, 67 against and 109 abstentions, the plenary adopted by urgent procedure a new regulation that should allow the faster development of vaccines and treatments against coronavirus.
Finding an effective and safe vaccine against the virus is the most viable option for controlling the pandemic. To this end, the Commission has proposed a strategy on vaccines that includes a temporary derogation, and strictly linked to the coronavirus, from certain rules on clinical trials.
Some COVID-19 vaccines and treatments already under development can be defined as genetically modified organisms (GMOs) and are therefore covered by Community legislation on GMOs. As national requirements for assessing the environmental risks of clinical trials for medicines containing or consisting of GMOs vary considerably between countries, a derogation is necessary to avoid significant delays in the development of essential life-saving vaccines and treatments.
The derogation will facilitate the development, authorisation and, consequently, the availability of coronavirus vaccines and treatments. In last week’s debate in the EP’s Environment, Public Health and Food Safety Committee, MEPs agreed that the rules need to be adapted, but stressed that the standards of quality, safety and efficacy of vaccines must be maintained.
09 July, European Medicines Agency: the presence of nitrosamines in medicines
Nitrosamines are classified as probable human carcinogens. The limits for nitrosamines in drugs have been set using internationally agreed standards (ICH M7(R1)) based on lifetime exposure. In general, patients should not be exposed to a lifetime cancer risk of more than 1 per 100,000 of the nitrosamines in their medicines.
The EMA Committee for Human Medicinal Products has issued an opinion requiring companies to take measures to limit as far as possible the presence of nitrosamines in human medicinal products and to ensure that the levels of these impurities do not exceed the established limits.
The measures shall ensure that nitrosamines are not present or are present below the levels identified to protect public health.
Companies will be required to have appropriate control strategies in place to prevent or limit the presence of these impurities and, where necessary, to improve their manufacturing processes. Companies will also have to assess the risk of nitrosamines being present in medicinal products and carry out appropriate testing if a risk is identified.
Detailed information for companies, including deadlines, will soon be available in updated documents on the EMA’s nitrosamines impurities website. In the meantime, companies should follow the current instructions.