Second wave pandemic preparedness: procurement principles
Brussels, 31 July 2020
Mr Jens Spahn,
Ms Stella Kyriakides,
Minister of Health, Germany
Commissioner for Health, European Commission
cc.
EMA
, ECDC
Dear EU Presidency Minister of Health, Dear Commissioner,
Medicines for Europe and EFPIA are coordinating a project on ICU medicines for Covid-19. In that context, we
have engaged strongly with the EU to ensure supplies during the first wave of the infection and subsequently
assessed the risks of a second wave anticipated after the summer break.
We appreciate that many member states are now engaged actively in planning for the risk of a second wave. We
respect that countries may choose different policy options to plan for a second wave risk adapted to local needs
and requirements. There are however some common challenges that we believe should be addressed to ensure
the most secure supply for Europe. Most member states are using a combination of measures to plan for a second
wave including stockpiling requirements and procurement. We would like to ensure that those measures
incentivise the industry to supply through sustainability and predictability for manufacturers. We have therefore
drafted some key principles that we would kindly request you convey to Health Council and the relevant EU
committees involved for best practice sharing.
Firstly, we are concerned by a lack of coordination among government agencies in different member states.
While we acknowledge that pandemic management is a new and complex field, on numerous occasions industry
has been confronted with different approaches within the same country. For example, regarding the EU joint
procurement, our industry has struggled to obtain clear information from government agencies on the intention
of the government to use this procurement process as opposed to other national contracts currently in place or
to be launched in the near future. In some cases, relevant government agencies were not even aware of the joint
tender to which the country had signed up to. We also note discrepancies in the guidance provided by regulatory
agencies responsible for medicine supply and crisis management departments responsible for the overall
pandemic response.
Second, we would like to request more transparency on the available Covid-19 ICU medicine stocks that
governments have either in state warehouses or in wholesaler warehouses for a second wave risk. We are aware
that there are, for example, large volumes of compounded medicines with very short stability periods (likely too
short to serve a second wave). It would be important to know if countries have sufficient (quality) medicines to
get them through a potential second wave. This information would be useful for the industry to plan stock and
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production levels and to ensure that products can flow to the countries of need and avoid over-supplying already
well stocked countries.
Third, as recommended in the latest Commission Communication, member states should share standardized and
epidemiological data at subnational level including hospitalization data and intensive care occupancy to allow
accurate modelling of the disease’s spread. This data should be collected by the ECDC and/or universities with
modelling capacity and shared in a timely fashion with the medicines industry.
Fourth, we are concerned about the propensity to increase national stockpiling requirements through threats of
higher fines for manufacturers sometimes combined with higher stock level requirements. In general, stockpiling
is counterproductive for industry supply chain models which are based on ensuring the rapid flow of goods to
enable manufacturing and to supply patient need. These requirements create considerable uncertainties for
manufacturers regarding product ownership and quality oversight that should be clarified. Moreover, hoarding
and restrictions to the free movement of goods including medicines were a cause of shortages and potential
harm to patients across Europe during the first Covid-19 wave. Going forward, it is critical that we maintain
principles of openness and solidarity across Europe. Introducing new stockpiling requirements and higher fines
also alters the sustainability balance for companies supplying the market. Europe has already experienced a
considerable withdrawal of marketing authorisations for well-established but still essential medicines over the
last 10 years due to higher regulatory costs combined with cost-containment measures. Disproportionate
stockpiling requirements will further increase market consolidation exposing Europe to over-reliance on a limited
number of suppliers.
Finally, as for procurement, we are concerned that some initiatives lack firm undertaking from member state
buyers. This can have the effect of locking in stock that may never be used for patients or may disincentivise
companies from participating in the market. In addition, the recently launched joint procurement of ICU
medicines is, in some cases, adding further uncertainty as some member states have deliberately chosen to
launch two tenders simultaneously – the joint procurement and a national procurement procedure. This creates
confusion for companies as member states have refused to clarify which procurement initiative and which
supplier(s) will be selected. This leads to a lack of transparency on real demand. In some cases, this appears to
be a deliberate policy to increase cost pressure on the industry. We question whether this is optimal given the
strong demand for Covid-19 medicines globally. Our industry would advise that procurement should reward
manufacturers that invest in resilience with clear purchaser commitments. Positive criteria could include
sufficient API and finished product stocks, multiple sources of API sourcing and inventory policies or
manufacturing sites (if produced by the medicine manufacturer), ability to deliver on reasonable lead times and
high historic service and quality levels (ranking by service delivery levels, GMP records, etc).
We look forward to cooperating closely with the Commission and Member States to plan for the risk of a second
wave.
Sent electronically, original signed by:
Medicines for Europe
EFPIA
patients • quality • value • sustainability • partnership
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