Publication
Keeping your dawn raid guidance current
Unannounced inspections or ‘dawn raids’ are used by antitrust authorities to obtain evidence when there are suspicions that individuals or businesses have infringed the antitrust rules.
France | Publication | April 2020
On April 8, 2020, the European Commission published guidelines aimed at ensuring an optimal and rational supply of medicines in order to avoid shortages during the COVID-19 outbreak.
Although these guidelines are primarily addressed to Member States and consist in providing them with orientations to organize the supply in their respective territories, they also invite the EU pharmaceutical industry as a whole to adopt responsible and solidary behaviors during this unprecedented health crisis.
Indeed, most of the orientations given to Member States in these guidelines appear to have direct impacts on pharmaceutical companies and on the way they will manage their businesses during this crisis, it being specified that the medicines concerned are not only those directly used in the treatment of COVID-19 patients, but also any other medicines that may be exposed to a risk of shortage.
The purpose of the table below is to summarize in a synthetic manner the main potential impacts of these orientations in order to allow pharmaceutical companies taking them into account in determining their crisis strategy.
Instructions to member states | Impacts for pharmaceutical companies in practice? | |
---|---|---|
EU solidarity |
Lifting exports bans and restrictions in the EU |
|
Avoiding national stockpiling |
|
|
Information of the sector on shortage risks |
|
|
Securing supply |
Increasing and reorganising production |
|
Ensuring manufacturing at full capacity |
|
|
Implementing regulatory flexibility |
|
|
Stocks monitoring |
|
|
Facilitating distribution and transport |
|
|
Ensuring fair distribution of supply |
|
|
|
Equitable distribution of available medicines |
|
Use of alternative treatments |
|
|
Extension of expiry dates of medicines |
|
|
Pharmacies sales |
Restrictions on dispensing |
|
Temporary restrictions of online sales |
|
|
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