Statement on air freight of critical medicines & supplies

Best practice guidance on how to protect workers in relation to Covid-19

Maintaining a fully operational pharmaceutical industry is considered essential, as it is critical to ensure an adequate supply of medicines.

Despite not being exposed to the same risk as healthcare professionals, industry personnel can follow many of the specific recommendations for healthcare professionals outlined in the national guidelines.

These are general recommendations only, which should be adapted to any country/company specificity. Medicines for Europe cannot be held legally liable for their implementation.

To ensure safety measures for the protection of workers in relation to Covid-19, we recommend the implementation of the following best practises:

  • Companies must have specific prevention plans for their facilities, organisation, manufacturing and control activities.

  • Contingency measures, such as the organisation of work shifts and/or the allocation and training of additional resources, should be foreseen in anticipation of casualties occurring.

  • In case of symptoms such as fever or respiratory symptoms – a cough, shortness of breath and/or breathing difficulties, the worker should be immediately removed from the post and isolated.

Preventive measures

Companies must have specific prevention plans for their facilities, organisation and manufacturing and control activities:

  1. Implement measures that minimise the numbers of non-essential personnel, visitors, contractors and suppliers from sites. When possible, teleworking should be organised for all non-essential workers (e.g. administrative activities) to minimise exposure.
  2. Most communication should be moved online or via telephone, movements within company premises, buildings and departments should be reduced to a minimum.
  3. Implement appropriate pre-screening for those who do have to enter (e.g. temperature checks).
  4. Workers should undergo training in line with the recommendations issued by public health authorities and instructions posted in public areas and all buildings.
  5. Provide the facilities and means to carry out prevention activities: such as hygienic washing and drying and essential preventive equipment (such as: soap, hydroalcoholic gels, gloves).
  6. Frequently clean and disinfect objects and surfaces that are touched regularly, using standard cleaning products. The cleaning and disinfection procedures of the areas of greatest contact and, therefore, with the highest risk of transmission (e.g. changing rooms and common areas) should also be revised, increasing the frequency of these operations if necessary. Where a digital time clock is not available, multiple time sheets should be provided to avoid unnecessary contact.
  7. Ideally (if possible) activities should be organised to avoid the simultaneous presence of many people in the same room, ensuring that the minimum recommended separation between them is maintained.
  8. The use of common areas (e.g. smoking rooms) should be avoided. In common areas that are in use (such as cafeterias and changing rooms) measures should include respecting an appropriate distance (at least 1 m), limiting the time spent in the common area and taking any possible action to ensure appropriate air hygiene.
  9. Additional measures should be taken to identify and protect workers with increased risks (age, pre-conditions) and ensure the necessary measures to protect them.
  10. Ensure appropriate Information dissemination. Set up a contact point where workers in any department can directly and immediately inform of their condition. This way information is not delayed or lost.

Actions to be taken in confirmed cases

In case of   symptoms such as fever or respiratory symptoms – a cough, shortness of breath and/or breathing difficulties, the worker should be immediately removed from the post and isolated. The space that they occupied at work should be instantly disinfected.

Workers with fever or acute respiratory symptoms will refrain from going to their workplace until their situation is assessed.

In line with the provisions for healthcare personnel, the testing for SARS-CoV-2 infection is recommended for those workers who are assigned to tasks considered essential, with a clinical focus on acute respiratory infection of any severity.

As long as a prevention plan is in place,   the personnel are considered at low risk of exposure to any case of probably or confirmed SARS-CoV-2 infection as long as the relationship with the probable or confirmed case does not include close contact (e.g. remote work with distance greater than 2m).

Contingency measures

The organisation of additional work shifts and/or the allocation and training of additional resources should be foreseen in anticipation of casualties occurring. Support staff should be foreseen, particularly for activities which are considered critical. For this purpose, the processes (production, quality or administrative) essential for the supply of the product must be evaluated.

Furthermore, with a worst-case scenario in mind, the need for an additional margin of safety in terms of stocks and terms should be anticipated.

Critical to keep the supply chain of essential medicines manufacturing operating at full capacity

EMA clarifies no scientific evidence to deter use of ibuprofen to manage coronavirus symptoms

The European Medicines Agency (EMA) has published today a press release to address concerns about the use of ibuprofen and other non-steroidal anti-inflammatory drugs (NSAIDs) in COVID-19 patients.

According to the Agency, when starting treatment for fever or pain in COVID-19, patients and healthcare professionals should consider all available treatment options including paracetamol and NSAIDs. Each medicine has its own benefits and risks which are reflected in its product information and which should be considered along with EU national treatment guidelines, most of which recommend paracetamol as a first treatment option for fever or pain.

In line with EU national treatment guidelines, patients and healthcare professionals can continue using NSAIDs (like ibuprofen) as per the approved product information. Current advice includes that these medicines are used at the lowest effective dose for the shortest possible period.

The agency also highlighted that there is currently no scientific evidence establishing a link between ibuprofen and worsening of COVID‑19. EMA is monitoring the situation closely and will review any new information that becomes available on this issue in the context of the pandemic and has committed provide further information as necessary and once the PRAC review is concluded.

Medicines for Europe update regarding medicines production and supply related to Covid-19

Medicines for Europe urgent requests to Interior & Transport ministries regarding medicines production and supply

Medicines for Europe statement on COVID-19 (‘coronavirus’)

European Industries welcome an important industry focus from the European Commission

Coordination with industry on potential impact of Covid-19 on medicines manufacturing and supplies in Europe

Protecting health: Active generic and biosimilar policies central to EU pharmaceutical strategy

A smart digital pharmacovigilance system should:

  • Medicines for Europe is ready to actively contribute to the announced European pharmaceutical strategy and Beating Cancer Plan.
  • The new pharmaceutical strategy should integrate measures to:
    • ensure uptake of generic and biosimilar medicines for improved access
    • set up pan-European cooperation to prevent shortages by addressing the root causes;
    • deliver guidelines on procurement of medicines under the EU Procurement Directive, including how to acknowledge investments in manufacturing and reward security of supply;
  • The Beating Cancer Plan should recognize the key role that generic and biosimilar medicines can provide for earlier, broader and de novo access to which otherwise are not accessible to patients.

Equitable and sustainable access to medicines is a concern across the EU. Policy reforms were discussed during the seminar “A European Union that ensures Patient Access & Sustainability”, organised by the Hungarian Permanent Representation to the EU with the support of the Croatian Presidency of the European Council. The seminar assembled high-level experts from the European Commission, OECD, health economists and representatives from different health care stakeholders.

According to the WHO, cancer is responsible for 20% of deaths in Europe[i]. With more than 3 million new cases every year which is expected to increase to more than 4.3 million by 2035[ii].The Beating Cancer Plan should overcome access barriers to existing oncology treatments in all EU member states. Generic and biosimilar medicines offer valuable opportunities for expanding access to oncology treatment for patients, while delivering efficiency to health systems.   A well-designed EU cancer plan cannot conceivably succeed without robust policies for generic and biosimilar medicines use.

Reports of medicines shortages are increasingly prevalent in Europe. Ensuring the availability of essential medicines should be an EU priority. The EU should tackle the economic and regulatory root causes of shortages and establish a pan-European mechanism to coordinate EU and national policies to reduce the risk of shortages and to avoid spill over effects through which one country’s policy would create supply issues in another. Preventing supply issues becomes especially pertinent considering the ongoing COVID-19 outbreak globally.

Among the measures discussed were guidelines on medicines procurement under the EU Procurement Directive, including how to acknowledge investments in manufacturing and supply security for Europe, supported by strong industrial and competitive policies to stimulate investment for the benefit of European patients.

Christoph Stoller, President, Medicines for Europe, concluded his opening remarks by calling for a “focused, action-oriented high-level pharmaceutical forum, so that all together, policy-makers, regulators, payers, industry and other stakeholders concerned can achieve the right balance between health objectives and industry competitiveness in Europe. Europe can only succeed by breaking down silos to jointly define and implement policy reforms in support of patient access to medicines”

[i] http://www.euro.who.int/en/health-topics/noncommunicable-diseases/cancer/cancer

[ii]https://ec.europa.eu/info/horizon-europe-next-research-and-innovation-framework-programme/mission-area-cancer_en