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Today the OECD and the European Union Intellectual Property Office published an extensive study on the issues and challenges posed by trade in counterfeit pharmaceutical products for governments, businesses and society.

Medicines for Europe member companies are at the forefront of the fight against counterfeit medicines. The European Union and industry have been working hand-in-hand to combat counterfeit and falsified medicines. In 2011, the EU adopted a Falsified Medicines Directive in order to prevent falsified medicines from reaching patients in Europe. As a result, since February 2019, prescription medicines in Europe must bear a 2-D datamatrix and anti-tampering device to enable pharmacists to verify their authenticity.

For the generic medicines industry, which supplies over 67% of prescription medicines, the effort was immense from a manufacturing, IT and regulatory perspective. Medicines for Europe members and other industry stakeholders set up European and national IT hubs (EMVO & NMVOs) with an investment of over 1 billion euros.

Adrian van den Hoven, Director General of Medicines for Europe and current President of EMVO stated: “The study published today confirms the importance of building a strong system that is able to prevent falsified medicines from entering the legal supply chain through which medicines reach patients. The huge financial investment by our members to put in place the FMD system aims primarily at ensuring that patients have access to safe medicines. Medicines for Europe remains committed to combating counterfeit medicines and will continue to cooperate with all stakeholders to ensure patient safety”

Open study

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.