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 icon
EU solidarity
 Lifting exports bans and restrictions in the EU
  • Potential impact on quotas for wholesalers and restrictions towards shortliners
Avoiding national stockpiling
  • Reflection to be conducted on allocation of stocks between States
  • Caution towards excessive or unusual orders: request justifications. If there is none, refusing supply may be envisaged
Information of the sector on shortage risks
  • Exchanges of sensitive information may contribute if properly organized (see Commission Temporary Framework [TF], 8 April 2020, on cooperation agreements during Covid-19)

Medical bottles iconSecuring supply

 Increasing and reorganising production
  • Possible cooperation between competitors in certain conditions (see TF of 8 April 2020), and to be encouraged by States
  • Monitoring stocks and capacities + informing authorities
Ensuring manufacturing at full capacity
  • State aid (cf. TF of 3 April 2020 on State aid during Covid-19)
  • Control by authorities of price competitiveness and against abusive practices (cartels, abuse of dominance)
Implementing regulatory flexibility
  • Facilitating variations to Marketing Authorisations (changing API supplier, new production site, extending expiry date)
  • Simplification of control procedures to facilite exports
Stocks monitoring
  • Help to production planning: authorities encouraged to provide epidemiologic data
  • Companies need to monitor stocks/prod. and inform authorities
Facilitating distribution and transport
  • Possible intervention of States to reduce cross-border delays and transport prices (earth, air freight, maritime/inland)
  • Reflection to be conducted on contracts with transporters
Ensuring fair distribution of supply
  • Caution towards excessive orders (see above)
  • Massive centralisation of purchases coordinated by States
  • Adaptation of Public Procurement rules (Guidelines, 1 April 2020)
  • Encouraging frequent calls for tender, of short duration, grouped

Buildings icon
Use by hospitals

 Equitable distribution of available medicines
  • Multiplication of grouped purchasing
  • Exchanges of information & reallocation of stocks betw. hospitals
  • Securing prices and terms & condition of sales
Use of alternative treatments
  • Flexibility to use medicines off-label, clinical tests, veterinary medicines
  • Caution: risks of consequential shortages on other indications
Extension of expiry dates of medicines
  • MA holders encouraged to request extension of expiry date for essential medicines for Covid-19
Medicine icon
Pharmacies sales

 Restrictions on dispensing
  • Possible limitation of quantities to deliver to patients for medicines at risk of shortage or subject to increased demand
  • Monitoring orders by pharmacies
Temporary restrictions of online sales
  • Potential restriction of authorized online retailers to better control supply of essential medicines
  • Increasing monitoring of online sales
     


作者

Marta Giner Asins
Marta Giner Asins
Partner
Email
marta.ginerasins@nortonrosefulbright.com
T: +33 (1) 56595272
Arnaud Sanz
Arnaud Sanz
Counsel
Email
arnaud.sanz@nortonrosefulbright.com
T: +33 1 56 59 53 34
Constance Chevreste
Constance Chevreste
Associate
Email
constance.chevreste@nortonrosefulbright.com
T: +33 (1) 56595405

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