COMMISSION STAFF WORKING DOCUMENT Synopsis report Accompanying the document COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Pharmaceutical strategy for Europe
Date: 2020-11-25
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU strategy, antimicrobial resistance, competitiveness, health care, innovation, pharmaceutical industry, pharmaceutical legislation, pricing of medicines, research and development, security of supply

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   EUROPEAN COMMISSION  Brussels, 25.11.2020  SWD(2020) 286 final  COMMISSION STAFF WORKING DOCUMENT Synopsis report Accompanying the document COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Pharmaceutical strategy for Europe {COM(2020) 761 final}  
 
 
SYNOPSIS REPORT 

1.  INTRODUCTION 

The  report  presents  the  outcome  of  the  stakeholders'  consultation  conducted  for  the 
Pharmaceutical  strategy  for  Europe.  The  consultation  covered  aspects  relating  to  access, 
availability and affordability of medicines, in the context of promoting sustainable innovation 
and support of EU industry to remain an innovator and world leader. 

Stakeholders  had  the  opportunity  to  provide  their  feedback  on  the  Commission  roadmap 
between  2  June  and  7  July  2020.  In  addition,  an  online  public  consultation  (OPC)1  of  all 
interested parties was conducted on the European Commission ‘Public consultations’ website 
from 16 June to 15 September 2020.  

A stakeholder workshop took place, 14 – 15 July 2020.  

Finally, ad hoc contributions were provided by stakeholders primarily through  meetings. 

2.  METHODOLOGY 

The analysis of the Commission roadmap was qualitative, drawing on machine learning and 
manual analysis to identify themes. Ten key themes were pre-identified A coding frame was 
created  for  each  theme.  In  some  instances,  respondents  submitted  the  same  answers  or  the 
same position paper. A screening took place to redline duplicate or irrelevant responses.  

For the OPC, analysis of cross-tabulations of closed answer questions and a qualitive analysis 
of  additional  textual  feedback  from  respondents  were  carried  out.  No  duplicate  responses 
were identified, but there was some evidence of coordinated action where some respondents 
provided the same open reply. Responses were analysed according to the four main themes of 
the consultation survey. 

3.  CONSULTATION ACTIONS 
a.  FEEDBACK MECHANISM ON COMMISSION ROADMAP 

There were 242 responses from stakeholders in 22 Member States and from outside the EU. 
After  the  screening,  232  responses  were  considered.  There  were  20  responses  from  citizens 
and  the  rest  from  organisations.  The  largest  number  of  responses  came  from  Belgium  (64), 
Germany (23) and France (18). From organisations, the largest proportion of responses came 
from organisations representing civil society (52), pharmaceutical industry (43) and business 
associations (33). 

The  most  commented  theme  was  the  supply  of  medicines  (including  dependency  of  supply, 
shortages  and  manufacturing  capacity)  followed  by  accessability.  Unmet  needs  and 
affordability also scored highly. Themes with low traction were simplification and incentives. 

In  general,  stakeholders  were  positive  about  the  roadmap  and  the  idea  of  a  Pharmaceutical 
strategy for Europe. They also overall agreed with the main issues presented in the roadmap, 
though the emphasis on issues varied between interest groups. Some healthcare respondents 

1 

https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12421-Pharmaceutical-
Strategy-Timely-patient-access-to-affordable-medicines 

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called  for  a  broader  health  strategy  and  some  public  authorities  would  like  the  Strategy  to 
extend to medical devices and in vitro diagnostics. 

Civil  society  organisations  underlined  the  importance  of  improving  affordability  and 
accessibility  of  treatments  to  address  unmet  medicial  need  while  industry  focussed  on 
ensuring  supply  and  improving  research  and  production  infrastructure  and  EU.  Public 
authorities stressed the need to increase production of active ingredients in Europe which was 
an issue taken on board across the stakeholders. 

Several themes had support across all respondents: increased research funding, secure supply 
chains, shortages, addressing unmet medical need together with reduced dependency on third 
countries for production of active ingredients and essential medicines. 

Access and affordability of medicines as well as adressing unmet medical need were a strong 
presence for civil society organisations, public authorities and healthcare respondents. These 
interest  groups  asked  for  further  aligning  incentives  and  research  with  public  interest  and 
unmet  medical  need,  new  pricing  and  procurement  models,  Member  State  collaboration  on 
pricing,  reimbursement  and  health  technology  assessment  (HTA),  and  revision  of  the 
legislations  on  medicines  for  rare  diseases  and  for  children.  Addressing  environmental 
concerns and technologies to replace animal testing in medicines testing were mentioned by 
healthcare respondents and citizens. 

The pharmaceutical industry and research and academia both supported improvement of the 
regulatory system. Research and academia expressed the need for enhanced cooperation with 
industry. In their view, greater cooperation in addition to maintenance of a strong intellectual 
property  rights  system,  could  generate  economic  benefits  in  terms  of  job  creation  and 
productivity in the EU. 

Respondents  from  industry  suggested  further  elaboration  on,  for  example,  promotion  of 
innovative manufacturing; addressing root causes for supply shortages and supply chain risk 
and  they  supported  use  of  real  world  data  and  evidence  into  clinical  development  and 
regulatory decision making, and building a European health data space.  

The generics industry focussed on increased competition, revision of procurement criteria and 
intellectual  property  rights.  The  small  and  medium-sized  enterprises  (SMEs)  expressed 
specific  interest  in  improving  access,  in  particular  through  actions  concerning  HTA  and 
reimbursement. 

b.  STAKEHOLDER WORKSHOP 

The  purpose  of  the  stakeholder  workshop  in  July  was  to  gather  stakeholders’  positions  on 
specific issues to inform the Pharmaceutical strategy. 

More  than  460  participants,  who  –  after  an  open  call  of  interest  –  were  invited  to  attend 
dedicated  sessions  to  ensure  a  balanced  representation.  Patients,  consumers,  pharmaceutical 
industry,  including  SMEs,  academia,  healthcare  professionals  and  Member  States  were 
represented. Participants attended from 22 Member States and also non-EU countries. 

The workshop featured an initial roundtable on the roadmap followed by dedicated sessions 
on:  

1) Access and incentives for patient centred innovation and umnet needs;  

2) Ensuring availability of pharmaceuticals to patients; and  

3) Ensuring affordablity of medicines for patients and health systems sustainability.  

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The main take aways were: 

  General  support  for  a  holistic,  patient  centred,  lifecycle  approach  in  the 

Pharmaceutical strategy; 

  Agreement  that  unmet  medical  need  should  be  patient  centred  and  support  to 
develop  a  definition  of  unmet  medical  need  and  that  incentives  are  important  to 
ensure development of medicines, but non-industry stakeholders were in favour of 
balancing incentives with obligations to ensure access; 

  Strong  support  for  evidence-based  actions  to  address  shortages,  call  for  specific 
actions  to  address  availability  issues  like  mapping  of  vulnerablities  in  the  supply 
chains and diversification of suppliers; 

  To address affordability a mix of approaches should be considered like stepping up 
information  sharing  efforts  between  Member  States,  for  example  on  prices  and 
procurement/payment models based on real world evidence. 

A summary of the workshop was published2. 

c.  ONLINE PUBLIC CONSULTATION 

There were 473 responses received from stakeholders in 26 Member States and from outside 
the EU. The majority of responses were from organisations and 47 from citizens. The largest 
number  of  responses  came  from  Belgium  (81),  Germany  (68)  and  France  (56)  and  47  from 
non-EU  countries.  The  largest  proportion  of  reponses  from  organisations  came  from  those 
representing  industry  (141),  including  49  SMEs,  healthcare  payer  or  provider  (85)  and 
academia, research, learned societies (62). 

Overall, the respondents found the most urgent issues to be addressed by the Pharmaceutical 
strategy  are  innovation  for  unmet  needs  (53%)  and  improvement  of  access  to  medicines 
(44%). 

International dependency and manufacturing 

More than 40% of the respondents provided input on actions or initiatives to incentivise the 
production of active ingredients  for  essential medicines  in the EU such  as  diversification of 
manufacturers,  tax  incentives  to  manufacturers  and  sustainable  pricing  of  products.  Actions 
suggested  to  enhance  the  quality  of  medicines  covered  strengthened  regulatory  oversight, 
encouraging  international  cooperation  for  high-quality  standards  in  manufacturing  and 
distribution, as well as more research.  

Access to affordable medicines 

Almost all respondents (87%) were concerned about shortages of medicines in the EU. Even 
though  increased  cooperation  between  national  authorities  featured  highly  among  actions, 
stakeholder  groups  had  different  positions  on  actions  to  address  shortages;  while  76%  of 
healthcare  respondents  and  70%  of  citizens  agreed  that  companies  with  a  centralised 
marketing authorisation should be required to market the medicine in all Member States only 
14%  of  pharmaceutical  industry  respondents  supported  this  action.  Industry  respondents 
called  for  actions  like  maintaining  regulatory  flexibility  brought  in  for  COVID-19  and 
harmonisation of marketing authorisations across the EU while healthcare respondents called 

2 https://ec.europa.eu/health/sites/health/files/human-use/docs/stakeholders_sum_workshop_en.pdf  

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for  a  framework  for  medicinal  donation  and  reuse  programmes  and  citizens  supported 
financial penalties for manufactureres not providing the required amounts of medicines. 

Also  on  prices  of  medicines  divergent  positions  existed,  with  industry  (72%)  finding  price 
levels justified which was in contrast to the civil society organisations (65%) and healthcare 
respondents (59%) who did not find prices justified. 

Innovation in early development and authorisation 

The  actions  considered  most  effective  to  support  innovative  research  and  development  of 
medicines  were  to  foster  research  collaboration  between  universities,  research  centres  and 
industry  (50%),  make  the  legislative  framework  more  adaptive  to  new  technologies  and 
advances in science (48%) and provide more public funding for research (35%). Stakeholder 
groups  had  different  emphasis  on  actions,  e.g.  civil  society  organisations  favoured  making 
public funding transparent and conditional on access and affordability, researchers expressed 
support for public-private cooperation and public authorities supported alignment of research 
and development spending with public health needs identified at EU level. 

For unmet medical need, there was support across stakeholders for more targeted research at 
EU level (61%) and agreement on a common understanding on what are the areas of unmet 
medical need in the EU (58%). 

Digital  technologies  were  considered  to  provide  opportunities  to  promote  development  and 
use of medicines in different ways also in terms of aligning price and value. However, across 
stakeholder  groups  there  was  consensus  that  these  technologies  are  associated  with  risks, 
e.g. non-compliance  with  data  privacy  and  lack  of  transparency  in  artificial  intelligence 
analysis. 

Environmental sustainability of medicines and health challenges  

The actions most supported across groups for limiting the environmental impact of medicines 
were stricter disposal rules for unused medicines (42%) and cleaner manufacturing processes 
(35%). Stakeholders also suggested other actions such as improvement of schemes for unused 
medicines, reutilisation of solvents and chemicals.  

To fight antimicrobial resistence, over half of the  respondents  considered that more prudent 
use  of antimicrobials would have  the biggest impact and found  support  should be given for 
researching/discovering new antimicrobials or their alternatives.  

d.  AD HOC CONTRIBUTIONS 

Pharmaceutical Committee 
Input  was  sought  from  Member  States  through  the  advisory  Pharmaceutical  Committee3.  In 
this forum, the Member States pointed to the need for a system allowing regulators to respond 
to  challenges  from  scientific  and  technological  developments  in  a  coordinated  manner.  The 
system  should  make  use  of  new  digital  technologies  in  development  and  monitoring  of 
medicines  while  ensuring  ethical  handling  and  protection  of  patients’  data.  Member  States 
suggested that the Pharmaceutical strategy covers medical devices and in vitro diagnostics in 
terms  of  access  and  regulatory  convergence  with  medicines.  Relevant  expertise  among 
regulators in new fields like data science needs to be ensured.  

3 https://ec.europa.eu/health/documents/pharmaceutical-committee/human-meeting_en  

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Member  States  identified  shortages  of  medicines  as  a  major  problem.  They  suggested  to 
establish a list of “essential medicines” and to ensure that the EU is not overly dependent on 
active  ingredients  from  third  countries.  Addressing  unmet  medical  need,  including 
development  of  new  antimicrobials,  requires  innovation  and  repurposing  of  medicines 
together  with  possibly  a  review  of  incentives.  Actions  on  access  should  be  combined  with 
stronger  enforcement  of  existing  obligations  on  marketing  authorisation  holders.  Equitable 
access  to  affordable  medicines  was  identified  as  an  important  issue  together  with 
pharmaceuticals in the environment. Finally, as the COVID-19 pandemic developed, Member 
States  put  more  emphasis  on  the  need  for  a  European  approach,  so  that  the  EU  is  better 
prepared for future pandemic crises.  

Ad hoc Group of the national authorities for pricing and reimbursement and public healthcare 
payers  

In  two  ad  hoc  meetings  of  representatives  of  the  national  authorities  for  pricing  and 
reimbursement and public healthcare payers, they voiced an interest for a standing EU level 
forum for exchange on issues of common interest and to allow  concerns of these authorities 
and bodies to be heard at EU level. 

In view of the upcoming Pharmaceutical strategy, the group flagged their broader concerns on 
the  functioning  of  pharmaceutical  markets,  coordination  challenges  and  issues  of  EU 
relevance.  These  include  the  impact  from  the  early  marketing  authorisation  schemes, 
incentives/creation  of  monopolies,  significant  price  increases  of  “older”  essential  products. 
According to the group reducing uncertainty and asymmetry of the information payers have 
over  the  real-life  effectiveness  and  costs  of  medicines  (for  instance  medicines  for  rare 
diseases)  is  needed.  Affordability  could  be  increased  through  common  guidelines  on  areas 
such as, pricing and procurement; having synergies with regulators, HTA bodies and payers; a 
better  understanding  of  research  and  development  costs  of  pharmaceutical  companies;  and 
cooperation  for  availability  of  generics.  Future  actions  could  build  on  the  current  tools  and 
instruments  from  the  EU  health  programme  and  on  existing  voluntary  regional  cooperation 
mechanisms. 

Engagement with the European Parliament 

On  11  September  2020,  the  European  Parliament  Committee  on  the  Environment,  Public 
Health and Food Safety held a technical briefing on the Pharmaceutical Strategy in which the 
background, objectives and main issues of the Strategy was presented by the Health and Food 
Safety  Directorate-General.  The  Committee  was  particularly  interested  in  how  the  Strategy 
would  cover  lessons  learnt  from  COVID-19,  preparedness  for  future  pandemics  and 
antimicrobial resistance actions as well as its linkage with the industrial strategy and funding 
for its implementation. 

Meetings of Commissioner Kyriakides with key stakeholders 

Commissioner  Kyriakides  has  since  June  2020  met  with  key  stakeholders  representing 
patients,  consumers,  healthcare  professionals,  pharmaceutical  industry  and  payers.  The 
stakeholders’ positions were consistent with those expressed in other consultation activities. 

Other outreach activities 

On 12 November 2020, Commissioner Kyriakides met with EU social partners representing 
employers and workers to discuss the Pharmaceutical strategy. The social partners expressed 
positions  that  converged  with  those  expressed  in  previous  consultation  activities,  and  skills 
featured more prominently in this meeting. 

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At Commission service level, Health and Food Safety Directorate-General has participated in 
conferences,  like  the  European  Health  Forum  Gastein  2020  and  the  The  Organisation  for 
Professionals in Regulatory Affairs (TOPRA) Symposium 2020, and meetings of stakeholder 
organisations.  Stakeholders  expressed  positions  identical  to  those  gathered  through  other 
consultation activities. 

4.  HOW FEEDBACK WAS TAKEN INTO ACCOUNT 

The  Pharmaceutical  strategy  for  Europe  is  wide-ranging  and  covers  the  issues  identified  by 
stakeholders  as  important  to  be  included  in  the  strategy.  The  strategy  also  sets  out  general 
actions for implementation. 

By  its  nature,  the  Pharmaceutical  strategy  for  Europe  is  a  document  that  addresses  the 
challenges  and  lays  down  policy  objectives.  It  aims  to  give  the  general  direction  for  each 
policy  aspect  and  specifies  specific,  but  high  level  actions.  The  Commission  services  have 
noted all the key messages mentioned in the consultations and summarised in this document. 
Most  of  the  recommendations  made  in  the  consultation  process  relate  to  specific  policy 
choices  that  are  more  relevant  for  the  implementation  phase  of  the  strategy  rather  than  the 
strategy  document  itself.  Even  so,  these  were  very  helpful  to  gauge  the  expectations  and 
positions of consulted parties and have been fully taken into account in the drafting process. 

In the implementation of the strategy, the options for the general actions will developed and at 
that  stage,  the  recommendations  from  stakeholders  will  be  further  examined  and  further 
engagement with stakeholders will take place. 

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