Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions - Safe, Innovative and Accessible Medicines: a Renewed Vision for the Pharmaceutical Sector
Date: 2008-12-10
Institutions: European Commission
Subjects: innovation, international market, medicinal product, pharmaceutical product, public health, trade regulations

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 10.12.2008 
COM(2008) 666 final 

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL 
COMMITTEE AND THE COMMITTEE OF THE REGIONS 

Safe, Innovative and Accessible Medicines: 
a Renewed Vision for the Pharmaceutical Sector 

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COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL 
COMMITTEE AND THE COMMITTEE OF THE REGIONS 

Safe, Innovative and Accessible Medicines: 
a Renewed Vision for the Pharmaceutical Sector 

TABLE OF CONTENTS 

1. 

1.1. 

1.2. 

1.3. 

2. 

2.1. 

2.2. 

2.3. 

3. 

3.1. 

3.2. 

4. 

Making further Progress towards a Single and Sustainable Market in Pharmaceuticals
...................................................................................................................................... 4 

Better Access to Medicines for European Patients ...................................................... 5 

Better Regulation for a More Competitive Industry .................................................... 7 

Safer Medicines for Better Informed Citizens ............................................................. 8 

Taking on the Opportunities and Challenges of Globalisation .................................. 10 

Tackling Worldwide Health Challenges .................................................................... 10 

Towards Global Cooperation and Harmonisation...................................................... 11 

Towards Global and Fair Competition....................................................................... 13 

Making Science Deliver for European Patients ......................................................... 14 

Supporting Pharmaceutical Research......................................................................... 14 

Keeping the Pace: New Horizons in Medicine .......................................................... 14 

Conclusion.................................................................................................................. 15 

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Introduction 

The  pharmaceutical  sector  makes  an  important  contribution  to  European  and  global  well-
being through the availability of medicines, economic growth and sustainable employment. It 
has been and remains a strategic sector for Europe. It employs more than 634,000 people and 
accounts for more than 17% of the EU Research and Development (R&D) expenditure. Most 
importantly, innovation in human medicines has enabled patients to benefit from treatments 
considered  unimaginable  a  few  decades  ago.  Demographic  change,  i.e.  ageing,  is  a  global 
phenomenon  which  will  affect  western  societies  as  well  as  major  emerging  economies  like 
China and Russia. Hence health-related services and products are growth markets worldwide 
and offer a potential for Europe's well- established pharmaceutical industry. 

Since 1965, Community action in the field has always had the dual objective of safeguarding 
public health by providing Europe with safe and effective medicines, while at the same time 
creating  a  business  environment  that  stimulates  research,  boosts  valuable  innovation  and 
supports  the  competitiveness  of  the  industry.  Much  has  been  achieved  in  forty  years. 
However,  at  the  beginning  of  the  21st  century  Europe  faces  major  health,  economic  and 
scientific challenges1: 

–  Europe has been losing ground in pharmaceutical innovation. The centre of gravity for 
research  has  moved  to  the  US  and  Asia.  New  international  competitors  emerge.  In  the 
1990s pharmaceutical research and development expenditures in Europe were higher than 
in  the  U.S.  (EUR  7.766  billion  compared  with EUR 5.342  billion).  However, the picture 
had changed by 2006 (EUR 22.500 billion in the EU while EUR 27.053 billion in the U.S). 
With regard to research sites a similar trend can be identified. Between 2001 and 2006 18 
research sites of 22 global pharmaceutical companies were closed in Europe (only 2 were 
opened) while in the same period these companies opened 14 research sites in Asia (one 
was closed) and six in the U.S. (five were shut down). While in general the number of new 
pharmaceutical  substances  has  decreased  worldwide,  the  decrease  has  been  significantly 
sharper in the EU than in the U.S. and other parts of the world. 

–  Shortcomings in the availability of medicines have been identified. In 2008, European 
patients still suffer from inequalities in availability and affordability of medicines. The last 
legislative  review2  and  the  creation  of  the  High  Level  Pharmaceutical  Forum3  are  major 
steps forward, but some key issues remain open. Future proposals of the Commission will 
also have to take into account the findings of the ongoing pharmaceutical sector inquiry. 

–  The sector is more and more globalised. Globalisation brings new opportunities with the 
opening  of  new  markets.  Industry  sales  outside  the  traditional  markets,  i.e.  industrialised 
regions  like  the  U.S.,  Europe  and  Japan,  are  increasing  significantly.  At  the  same  time, 
worldwide cooperation and trade lead to a global division of labour. Hence a new medicine 
is often the result of research and development in Europe, clinical trials in India, and active 
ingredients produced in China before finally produced, packaged and sold in the EU. This 
"global"  reorganisation  creates  new  opportunities  but  also  new  challenges,  in  particular 
counterfeit medicines are on the rise. 

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3 

Similar challenges exist for veterinary medicine but are not covered by this Communication. 
OJ L 136, 30.4.2004 p. 1 – 33, OJ L 136, 30.4.2004 p. 34 – 57 and OJ L 136, 30.4.2004 p. 58 – 84. 
http://ec.europa.eu/enterprise/phabiocom/comp_pf_en.htm 

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–  Scientific breakthroughs revolutionize the way medicines are developed and prescribed. 
Treatments  become  more  personalised.  Linked  to  the  ageing  of  the  population  and  to  a 
proactive involvement of patients, the demand of society is also evolving. At the same time 
unmet  medical  needs  are  to  be  met,  e.g.  infectious  diseases  (like  tuberculosis  and 
HIV/AIDS) and rare diseases whose ramifications are not limited to the EU but pose global 
public health challenges. 

To  address  these  challenges,  this  Communication  outlines  the  Commission's  vision  of  the 
future of the sector and intends to trigger a process which leads to a way forward. Based on 
three pillars, concrete objectives are proposed: 

(1) 

(2) 

(3) 

To  make  further  progress  towards  a  single  and  sustainable  market  in 
pharmaceuticals and; 

To take on the opportunities and challenges of globalisation; 

To  make  science  deliver  for  European  patients  and  restore  the  EU's  role  as  the 
natural home for pharmaceutical innovation. 

The Commission's vision is to ensure that European citizens can increasingly benefit from a 
competitive  industry  that  generates  safe,  innovative  and  accessible  medicines.  Many 
initiatives have been taken in this direction, most recently with the inclusion of eHealth in the 
Commission's lead market initiative that aims to remove barriers to the acceleration of market 
development4. The five accompanying legislative proposals (on counterfeiting, information to 
patients  and  safety  monitoring5)  are  further  important  steps  towards  this  vision,  while  other 
concrete objectives are listed in the Annex. 

1. 

MAKING  FURTHER PROGRESS  TOWARDS  A SINGLE  AND SUSTAINABLE MARKET  IN 
PHARMACEUTICALS 

Major  progress  has  been  achieved  over  the  last  years.  Legislative  initiatives  of  the 
Commission have led to improved marketing authorisation procedures, the harmonisation of 
data  protection  in  the  EU,  better  access  to  medicines  for  children,  and  a  new  regulatory 
framework for advanced therapies like tissue engineering. Furthermore the Guiding Principles 
concerning  pricing  and  reimbursement  developed  by  the  Pharmaceutical  Forum  are  major 
steps.  Nevertheless  stakeholders  continue  to  raise  concerns  with  regard  to  the  market 
fragmentation  linked  to  disparities  in  national  pricing  and  reimbursement  schemes, 
unnecessary regulatory burdens caused by divergences in the implementation of Community 
legislation, and a lack of commercial interest in national markets which are economically less 
attractive. 

This situation may create important inequalities between patients in the access to medicines 
while the growth potential of the EU industry is hampered. 

Completing the single market in pharmaceuticals remains an important objective. 

4 

5 

Communication  "A  lead  market  initiative  for  Europe"  -  COM(2007)  860  (21.12.2007).  The 
Communication  and  all  relevant  documents  are  available  at  the  official  EC  LMI  microsite: 
http://ec.europa.eu/enterprise/leadmarket/leadmarket.htm 
COM(2008) 668, COM(2008) 662, COM(2008) 663, COM(2008) 664, COM(2008) 665. 

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1.1. 

Better Access to Medicines for European Patients 

1.1.1.  Ensuring Affordable Access to state-of-the-art Treatments without Delays 

The lack of critical medicines in particular due to a lack of adequate financial resources is an 
issue that has reached the highest political level, as exemplified by the 'Bremen Declaration'6 
in the case of HIV/AIDS, where Health Ministers committed to cooperate to order to ensure 
access to affordable medication in view of existing problems for patients in several Member 
States to have access to urgently needed medication. 

The lack of available of medicines has also been highlighted in a recent report of the Heads of 
Medicines Agencies7 and by the Pharmaceutical Forum8. The problem is particularly striking 
in  those  Member  States  where  the  national  market  is  small  and  the  expected  return  on 
investment for companies is low. 

This  has  important  public  health  consequences  in  several  Member  States,  despite 
improvements due to the last review of the EU pharmaceutical legislation. In the short term, 
minor changes to the regulatory framework (e.g. on linguistic regimes and labelling) can be 
made to improve the situation. However, a more in-depth review of the situation is required to 
fully address the issue. Beyond regulatory aspects the role of full-line and public wholesalers9 
in the supply of medicines in small markets needs also to be examined in more detail. 

More broadly, the functioning of the network of EU medicines authorities requires re-thinking 
to  improve  its  efficiency,  minimise  the  regulatory  burden  it  generates  and  thus  speed  up 
market access for medicines. 

Objective  #1:  Options  to  improve  the  availability  of  medicinal  products  for  patients  in 
need,  with  a  particular  focus  on  smaller  markets  should  be  developed  in  close  cooperation 
with Member States by 2010. 

Objective #2: Based on an evaluation of the European Medicines Agency (EMEA) ways to 
optimise the functioning of the network of EU medicines authorities should be identified by 
2010. 

The fragmentation of the EU market primarily relates to the diversity of national pricing and 
reimbursement schemes. Decisions on costs of healthcare and pharmaceuticals are a national 
competence  but  must  comply  with  Directive  89/105/EEC  and  the  EC  Treaty,  requiring  in 
particular  that  pricing  and  reimbursement  decisions  are  made  in  a  timely  and  transparent 
manner. 

Allocating  healthcare  funds  to  the  most  effective  medicinal  products  as  well  as  creating  the 
right environment for price competition is of major importance to ensure the sustainability of 
healthcare systems. Different systems lead to disparities in pricing, time-to-market delays and 
access inequalities. Member States are entitled to make political choices on which medicines 
to reimburse, in line with the provisions of the Transparency Directive, and to take decisions 

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http://www.eu2007.de/en/News/download_docs/Maerz/0312-BSGV/070Bremen.pdf 
Availability of Medicinal Products, HMA, 5/11/2007. 
http;//ec.europa.eu/enterprise/phabiocom/comp_pf_en.htm 
http://ec.europa.eu/enterprise/phabiocom/comp_pf_en.htm 

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which  take  into  account  the  effectiveness  and  value  for  money  of  innovative  medicines  as 
well as the budgetary constraint in Member States. 

However,  availability  and  affordability  of  medicines  have  a  European  dimension.Different 
national  pricing  and  reimbursement  schemes  create  a  complex  landscape  in  the  EU  while 
Member States face the common challenge of balancing three overarching objectives: optimal 
use  of  resources  to  ensure  sustainable  financing  of  healthcare  for  an  ageing  European 
population,  access  to  medicines  for  EU  patients  and  reward  for  valuable  innovation.  A 
common  set  of  Guiding  Principles10  has  been  adopted  by  the  Pharmaceutical  Forum  to 
support  future  national  pricing  and  reimbursement  policies.  The  positive  experience  of 
information exchange and cooperation between Member States and with stakeholders should 
be strengthened at EU level. 

Similar price levels can lead to a different level of affordability depending on the economic 
situation  in  each  Member  State.  More  efficient  market  mechanisms  and,  in  particular,  price 
competition for non-reimbursed medicines, would provide, in this sector, more patients choice 
at  a  more  affordable  cost.  Member  States  should,  therefore,  remove  price  controls  on 
manufacturers that prevent full competition of authorized medicines that are neither purchased 
nor reimbursed by the State. 

Further  development  of  health  technology  assessments  will  also  offer  valuable  support  to 
national  authorities  to  strike  a  balance  between  containing  pharmaceutical  expenditure  and 
ensuring  a  fair  reward  for  valuable  innovation  and  access  to  the  best  available  medicines. 
Cooperation  among  authorities  and  dialogue  with  stakeholders  will  be  a  prerequisite  to 
achieve  such  a  balance.  Based  on  the  agreement  found  in  the  Pharmaceutical  Forum  the 
exchange of data between Member States on relative effectiveness should be fostered. 

Objective #3: Genuinely transparent and speedy pricing and reimbursement decisions should 
be made possible by enhancing the application of the Transparency Directive. 

Objective #4: Based on the work of the Pharmaceutical Forum the exchange of information 
and  the  cooperation  among  stakeholders  on  pricing  and  reimbursement  should  be 
improved. 

Objective  #5:  Based  on  the  agreement  found  in  the  Pharmaceutical  Forum  the  exchange  of 
data  between  Member  States  on  relative  effectiveness  should  be  fostered  in  order  to  avoid 
delays in the market access of innovative treatments. 

1.1.2. 

Improving Competition and Market Access 

Competition  is  an  efficient  way  to  stimulate  valuable  innovation  and  improve  medicines' 
affordability.  In  January  2008,  the  Commission  has  launched  a  sector  inquiry  into  the 
pharmaceutical  sector  on  the  basis  of  Article  17  of  Regulation  No  1/200311.  The  inquiry 
concerns "the introduction of innovative and generic medicines for human consumption onto 
the  market"12.  The  inquiry  was  initiated  as  certain  circumstances  in  general  suggest  that 
competition may be restricted or distorted in the pharmaceutical sector in Europe, such as a 
decline in innovation as measured by the number of novel medicines reaching the market and 

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http://ec.europa.eu/enterprise/pharmaforum 
OJ L 1, 4.1.2003, p.1 
For further details: http://ec.europa.eu/comm/competition/sectors/pharmaceuticals/inquiry/index.html. 

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instances  of  lacking  timely  entry  by  suppliers  of  generic  medicines.  The  main  focus  of  the 
inquiry  is  the  commercial  behaviour  of  market  participants  affecting  market  entry  of 
competing novel or generic medicines. The preliminary results will be presented in a report 
scheduled for 28 November 2008. The final report is foreseen for spring 2009. 

In  addition,  the  Commission  plans  to  launch  an  in-depth  monitoring  of  the  functioning  of 
markets  in  the  pharmaceutical  sector.  This  action  is  part  of  the  follow-up  to  the  November 
2007  Single  Market  Review  which  aimed  to  improve  the  governance  of  the  Single  Market 
through a systematic and integrated market monitoring of key markets. 

The  Commission  will  take  into  account  its  findings  in  the  ongoing  pharmaceutical  sector 
inquiry and this market monitoring exercise when making future legal proposals. 

Many  Member  States  recognise  that  generic  medicines  play  an  important  role  in  helping  to 
limit  their  healthcare  expenditure  in  their  reimbursement  and  prescribing  practices. 
Competition with off-patent products enables sustainable treatment of more patients with less 
financial  resources.  The  generated  savings  create  financial  headroom  for  innovative 
medicines. All actors should therefore ensure that generics can enter the market after expiry of 
patent and data exclusivity protections and compete effectively. 

Equally, non-prescription medicines also play an important role since they offer economic as 
well  as  social  benefits.  Self-medication  empowers  patients  to  treat  or  prevent  short  term  or 
chronic illnesses which they consider not requiring the consultation of a physician or which 
may  be  treated  by  the  people  after  an  initial  medical  diagnosis.  Consequently,  access  and 
availability of these medicinal products require particular attention. 

Objective  #6:  Ways  to  ensure  availability  and  market  access  for  generics  and  non-
prescription medicines should be examined by 2011. 

Objective  #7:  Launch  of  an  in-depth  monitoring  of  the  functioning  of  markets  in  the 
pharmaceutical sector. 

Patients'  expectations  to  health  systems  and  quality  of  care  in  relation  to  cross-boarder 
healthcare also call for a more coordinated EU action. The proposed Directive on cross-border 
healthcare13  sets  out  common  principles  to  ensure  safety  and  quality  of  care,  a  specific 
framework  on  cross-border  healthcare  and  provisions  for  cooperation  between  national 
systems. The proposal also provides for cross-border recognition of medical prescriptions. 

1.2. 

Better Regulation for a More Competitive Industry 

Requirements that cause a high administrative burden without providing a clear public health 
benefit have a strong negative impact on the competitiveness of the EU industry. Small and 
medium-sized enterprises (SMEs) are economically affected in particular, e.g. in the field of 
pharmacovigilance  redundant  reporting  requirements  in  different  Member  States  create 
unjustified  costs.  Such  obstacles  may  be  decisive  for  these  enterprises  not  to  apply  for 
marketing authorisations outside their Member State of origin. 

However,  in  view  of  the  fact  that  national  regulators  are  involved  in  legislation  and 
responsible  for  the  implementation  a  high  level  of  joint  commitment  is  required  from  all 

13 

COM(2008) 414. 

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actors  in  order  to  make  pharmaceutical  rules  clearer,  simpler  and  more  flexible  without 
compromising public health. 

1.2.1.  A better Framework on 'Variations' 

The  Commission  recognises  the  burden  that  current  rules  on  changes  to  the  marketing 
authorisations  of  medicines  ('variations')  entail.  This  complex  framework  hinders  the 
introduction  of  changes  that  are  beneficial  to  patients  and  delays  access  to  improved 
treatments. 

1.2.2. 

Improving the Framework on Clinical Trials 

A  number  of  stakeholders  have  raised  concerns  (e.g.  divergence  in  interpreting  the  relevant 
legislation  and  cumbersome  procedures  for  multi-centre  clinical  trails  in  different  Member 
States)  over  the  application  by  Member  States  of  the  Directive  on  Clinical  Trials14  and  its 
impact  on  academic  as  well  as  non-academic  research.  The  recent  EMEA-Commission 
conference15 has identified shortcomings in applying the Directive. An in-depth assessment of 
the matter and recommendations for improvement should now be undertaken. 

Objective #8: An assessment of the application of the Clinical Trials Directive with a view 
to  making,  if  appropriate,  legislative  proposals  -  while  taking  into  account  the  global 
dimension of clinical trials - should be presented by the Commission by 2010. 

1.3. 

Safer Medicines for Better Informed Citizens 

1.3.1. 

Improving Safety 

Recent events linked to adverse reactions demonstrate that the safety of medicines remains a 
major public health issue. To tackle it, the Commission has submitted a legislative proposal16 
to rationalise and strengthen the EU framework on safety monitoring ('pharmacovigilance'). 

Objective  #9:  The  proposal  to  rationalise  and  strengthen  the  EU  framework  on 
pharmacovigilance should be adopted swiftly. 

Another important health issue also follows from the increased number of medication errors 
which have led to severe medical conditions for patients, such as medicine name confusions, 
and  prescription,  dispensing  and administrative  errors.  To  address  this,  the  Commission  has 
developed  new  strategies  to  reduce  the  scale  of  medication  errors  in  the  above  mentioned 
proposal  and  to  specify  quality  criteria  for  Health  related  websites17.  The  Commission  has 
also confirmed that patient safety will be a priority for 2008, through a proposal addressing 
systemic patient safety issues, which aims to reduce all adverse events in healthcare, including 
medication  errors,  as  well  as  specific  measures  aimed  at  the  prevention  and  control  of 
healthcare-associated infections18. 

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OJ L 121, 1.5.2001, p. 34. 
http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/archives_en.htm, 30.11.2007. 
COM(2008) 665, COM(2008) 664 
COM(2002) 667 
http://ec.europa.eu/atwork/programmes/docs/clwp2008_en.pdf 

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1.3.2.  Empowering Patients 

As outlined in the Commission White paper on Health Strategy19, patients are becoming more 
involved  in  the  decision-making  regarding  their  health.  They  have  a  right  to  more  quality 
information on available medicines, the grounds on which they have been authorised and how 
they are monitored. 

Public authorities and health care professionals have a crucial role in providing patients with 
relevant and impartial information. The Pharmaceutical Forum endorsed recommendations to 
enhance the generation, access and dissemination of good quality information on diseases and 
treatments. The use of quality principles and the increased cooperation among all partners for 
developing patient information should lead to tangible improvements for citizens. 

However, information provided by public authorities currently varies considerably, and media 
such  as  the  internet  may  not  always  provide  reliable  or  understandable  data.  This  became 
clear  in  a  recent  report  prepared  by  the  Commission  in  response  to  a  request  from  the 
European Parliament and the Council20. On this basis, the Commission considers that the role 
of industry in this context should be clarified and presents a legislative proposal to rationalise 
the  availability  and  improve  the  quality  of  information  to  patients  within  the  EU21  on 
prescription-only medicines. Industry should be given the opportunity to provide, under strict 
conditions,  quality  information.  In  that  context,  all  actors  and  in  particular  industry  and 
Member  States  should  pay  attention  to  the  specific  linguistic  needs  of  patients  belonging  to 
minorities or with an immigration background. 

Objective #10: The Conclusions and Recommendations of the Pharmaceutical Forum's work 
on information to patients on diseases and treatments should be taken forward. 

Objective  #11:  Measures  to  ensure  that  the  information  provided  by  the  industry  to  those 
who seek it is reliable and objective should be taken. 

1.3.3.  Addressing the Environmental Impact 

Pollution  of  waters  and  soils  with  pharmaceutical  residues  is  an  emerging  environmental 
problem  and  also  an  emerging  public  health  concern.  The  Commission  recognizing  these 
concerns  has  funded  several  research  projects  to  assess  possible  environmental  and  health 
impacts  of  pharmaceuticals.  It  is  now  necessary  to  focus  on  measures  that  could  reduce  the 
potentially  harmful  impact  of  pharmaceuticals  on  the  environment  and  public  health.  Areas 
for further actions include evaluating environmental information on pharmaceuticals collected 
by  the  European  Medicines  Agency  and  national  medicines  authorities  with  a  view  to 
integrating this information into the current EU legislative framework. 

Objective #12: Measures to reduce the potentially harmful impacts of pharmaceuticals on 
the European environment and public health should be proposed.  

19 
20 
21 

COM(2007) 630. 
COM(2007) 862 
COM(2008) 662, COM(2008) 663 

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2. 

TAKING ON THE OPPORTUNITIES AND CHALLENGES OF GLOBALISATION 

The EU pharmaceutical industry operates in a global economy. Globalisation brings important 
benefits, such as the opening of foreign markets and the rise in purchasing power, particular in 
emerging economies. Research-based as well as generic manufacturers see increasing market 
opportunities through public funding schemes as well as a growing number of patients  who 
are  able  to  pay  for  best  available  treatment  options  in  emerging  economies.  The  EU-based 
industry  is  responding  to  the  changing  environment  in  different  ways.  On  the  one  hand 
innovators  as  wells  as  generic  manufacturers  are  increasingly  tapping  into  markets  of 
emerging  economies  while  outsourcing  and  internationalising  research  and  development  on 
the  other  hand.  Furthermore,  they  increasingly  rely  on  active  pharmaceutical  ingredients 
(API)  imported  from  Asian  countries  as  precursors  for  their  finished  products,  thus 
maintaining their production capacity in the EU. 

However,  globalisation  also  leads  to  new  public  health  challenges.  Protecting  European 
citizens  by  addressing  these  challenges  is  a  priority  of  EU  pharmaceutical  policy.  The 
Commission  is  also  committed  to  improving  medicine  availability,  affordability  and  access 
worldwide in the interest of global health. 

2.1. 

Tackling Worldwide Health Challenges 

2.1.1. 

Illegal Medicinal Products 

The Commission has recently adopted a Communication on an Industrial Property Rights 
Strategy  for  Europe  and  a  core  element  of  the  strategy  is  effective  enforcement  of 
Intellectual  Property  Rights.  Illegal  medicines  exist  in  several  forms,  one  of  them  being 
counterfeit  medicines.  Safety  is  a  prerequisite  for  trade  of  medicines.  A  study  launched  in 
2006  by  the  Commission  on  the  distribution  of  pharmaceuticals  revealed  that  a  growing 
number of medicines are subject to counterfeiting in the EU.  

The  Commission  "Report  on  Community  Customs  Activities  on  Counterfeit  and  Piracy"  for 
200722 also revealed that medicines seized by customs authorities increased by 628% in just 
two  years  (2005-2007).  They  relate  not  only  to  'lifestyle'  products,  but  also  to  treatments 
against  life-threatening  diseases.  Existing  contacts  in  regulatory  cooperation  with  third 
countries should be intensified in order to combat illegal medicinal products. 

On this basis, the Commission presents a legislative proposal23 to effectively protect European 
citizens from this major health threat and ensure that medicines bought from the legal supply 
chain are fully reliable. Various means are proposed, ranging from product-related measures 
(such  as  obligatory  safety  features  allowing  traceability)  to  strengthened  obligations  for 
wholesale  distributors.  The  proposal  also  addresses  all  other  actors  in  the  supply  chain  and 
clarifies their responsibilities. 

Tackling counterfeiting requires joint international efforts. Bilateral cooperation with targeted 
third  countries  must  be  further  developed.  New  mechanisms  of  exchange  of  information  on 
illegal distribution channels and counterfeiting should be established. 

22

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http://ec.europa.eu/taxation_customs/resources/documents/customs/customs_controls/counterfe

it_piracy/statistics2007.pd 
COM(2008) 668 

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The  Commission  is  working  intensively  with  European  and  international  partners  on  this 
topic. It is an active member of the World Health Organization (WHO) International Medical 
Products  Anti-Counterfeiting  Task  Force  (IMPACT)24,  which  has  delivered  principles  on 
legislation against counterfeit medical products, and furthermore the Group of Specialists on 
Counterfeit Pharmaceutical Products (PC-S-CP) of the Council of Europe.  

Objective #13: The proposal to prevent the entry of illegal medicinal products into the legal 
supply chain should be adopted swiftly. 

Objective  #14:  An  intensified  exchange  of  information  on  illegal  distribution  channels  in 
relation to counterfeit medicinal products should be proposed by 2012. 

Objective  #15:  Within  IMPACT,  third  countries  developing  and  enforcing  legislation 
against counterfeit medicinal products should be assisted by the Commission. 

2.1.2.  Preparing to combat Pandemics 

The growing number of avian flu cases has proven that a comprehensive strategy in the field 
of infectious diseases, notably against pandemics, is necessary. 

Much has already been achieved in this field, e.g. in facilitating the marketing authorisation of 
vaccines  against  pandemics.  EU  preparedness  planning  is  well  established25  and  a  targeted 
legal  framework  has  been  set  up  under  which  several  products  against  pandemic  flu  have 
already been authorised. 

However,  the  international  dimension  of  the  EU  influenza  strategy,  including  UN  (WHO, 
FAO,  UNICEF  etc.)  and  OIE,  needs  to  be  strengthened  so  as  to  provide  EU  citizens  with 
effective  vaccines  without  delays  after  an  outbreak  has  occurred.  Regulatory  cooperation 
between  the  EU  and  third  countries  should  provide  a  platform  to  share  information  on 
medicines  against  pandemics  and  to  benchmark  pandemic  preparedness  plans,  as  well  as 
sharing influenza strains and improving access to vaccines and other benefits. 

Objective  #16:  To  improve  international  cooperation  in  the  field  of  pandemics,  existing 
bilateral and multilateral relations with third countries should be strengthened and extended. 

2.2. 

Global Cooperation and Harmonisation 

2.2.1. 

Strengthening international cooperation 

Tackling  worldwide  health  threats  is  in  itself  a  sufficient  reason  to  strengthen  international 
cooperation.  The  global  burden  of  disease  is  increasing,  including  poverty-related  and 
neglected diseases which disproportionately affect developing countries. Recognising this, the 
EU  played  a  constructive  role  recently  in  developing  the  WHO's  new  Global  Strategy  on 
Public  Health,  Innovation  and  Intellectual  Property  aiming  at  fostering  the  availability  of 
innovative  products  addressing  the  public  health  challenges  in  these  countries.  The 
Commission has already begun to promoting research with and for Africa on new treatments 
for  neglected  diseases.  The  EU  has  also  taken  steps  to  enable  international  companies  to 
provide medicines at substantial discounts to developing countries while ensuring that these 

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http://ec.europa.eu/health/ph_threats/com/Influenza/influenza_level_en.htm  

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preferential prices do not lead to negative repercussions in the EU market by reimportation. 
Furthermore  the  EU  supports  the  Global  Fund  to  fight  against  AIDS,  Tuberculosis  and 
Malaria in developing countries. The significant financial contributions from public as well as 
private sources like charities enable the Global Fund to boost prevention, treatment and care 
in order to accelerate the urgently needed response to these three diseases.  

There  are  a  number  of  other  compelling  grounds  to  strengthen  international  cooperation 
related to globalisation. 

Firstly,  a  growing  number  of  medicines  are  now  developed  in  a  multi-centre,  international 
way.  Clinical  trials  are  often  done  outside  Europe,  including  through  the  European  and 
Developing Countries Clinical Trials Partnership (EDCTP). Ingredients and finished products 
are more and more sourced through international distribution channels. This makes the task of 
authorities (evaluation of trials, inspections of sites) more difficult and resource-intensive. 

Secondly,  companies  increasingly  operate  worldwide.  Side  effects  recorded  throughout  the 
world may be relevant to European patients as well. It is therefore essential that the EU has 
access to such information. Global monitoring requires global cooperation. The Commission 
is  committed  to  addressing  these  challenges  in  a  proactive  manner.  EU  international 
cooperation  has  been  significantly  strengthened  since  2005.  Confidentiality  arrangements 
with the US, Japan and Canada have been established. Yet, bilateral cooperation must still be 
further  enhanced  to  better  share  information  on  the  safety  of  medicines  and  coordinate 
actions.  Mutually  agreed  mechanisms  for  inspections  should  also  be  agreed  to  avoid 
duplication of work. 

Cooperation must be intensified with other key third countries (e.g. Russia, India, and China) 
where  more  and  more  clinical  trials  are  carried  out  and  active  ingredients  produced. 
Compliance  with  the  ethical  principles  of  the  Helsinki  Declaration26  must  be  a  common 
objective for clinical trials in third countries. First steps have already been achieved, notably 
with India. Concrete initiatives such as training of regulators, information sharing procedures 
and work towards common standards should be initiated to increase mutual understanding and 
confidence. 

Objective  #17:  The  regulatory  cooperation  with  the  US,  Japan  and  Canada  within 
existing confidentiality arrangements, focusing on safety monitoring should be intensified. 

Objective  #18:  Mutually  agreed  mechanisms  for  inspections  in  third  countries  should  be 
proposed to these three countries by 2010. 

Objective  #19:  Bilateral  cooperation,  including  the  research  field,  with  Russia,  India  and 
China,  focusing  on  clinical  trials  and  the  manufacture  of  active  ingredients  should  be 
strengthened. 

Objective  #20:  Training  and  information  sharing  procedures  with  these  three  countries 
should be fostered. 

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2.2.2.  Promoting Global Harmonisation 

Establishing  and  enforcing  international  public  health  standards  is  essential  to  minimise  the 
risk that unsafe products enter the EU market. The work carried out with the US and Japan at 
the International Conference on Harmonisation (ICH) is essential in this context and must be 
expanded. ICH standards should be promoted so that they can become worldwide standards. 

International  cooperation  also  provides  opportunities  to  strengthen  the  EU  position  by 
launching  initiatives  that  benefit  European  companies.  The  EU-US  Transatlantic  Economic 
Council  (TEC)27,  in  particular,  provides  a  unique  chance  to  bring  closer  the  two  biggest 
pharmaceutical  markets  in  the  world,  lowering  costs  by  reducing  unjustified  regulatory 
divergences.  Important  simplification  initiatives  such  as  the  action  plan  adopted  after  the 
Transatlantic Workshop on Administrative Simplification28 have already been initiated. Joint 
upstream  regulatory  dialogue  initiatives  with  other  third  countries  could  prove  to  be 
successful and should be further developed. 

Objective  #21:  International  harmonisation  at  ICH  and  the  promotion  of  the  use  of 
international  standards  by  third  countries  beyond  the  US  and  Japan  should  be  further 
developed. 

Objective #22: Using the TEC areas for simplification and convergence of rules between 
the  US  and  the  EU  and  engaging  in  upstream  regulatory  dialogue  for  major  legislative 
proposals should be pursued. 

2.3. 

Towards Global and Fair Competition 

New  markets  (China,  India,  Brazil,  Russia,  Indonesia,  Mexico  and  Turkey)  are  expected  to 
represent one fifth of the global sales by 2020. Globalisation and the opening of these markets 
therefore  bring  major  business  opportunities  for  EU  companies.  At  the  same  time,  new 
competition  from  India,  China  and  other  Asian countries  is  emerging.  These  countries  have 
already  become  centres  in  producing  Active  Pharmaceutical  Ingredients  (APIs)  and  prime 
sources for European imports of those substances. 

Europe is in a good position to compete globally, provided the competition is fair, i.a. based 
on  international  rules.  However,  it  is  acknowledged  that  non-tariff  barriers  often  impede 
market  access  for  European  operators  while  at  the  same  time  non-EU  companies  enjoy  full 
access to open European markets. Therefore, the Commission has established cooperation in 
various  areas  relevant  to  pharmaceuticals  with  emerging  trading  partners  in  order  to  ensure 
that  EU  companies  are  able  to  compete  on  a  level  playing  field  in  foreign  markets,  in 
particular that their competitors abide by the World Trade Organisation (WTO) rules. 

Objective  #23:  The  EU  should  work  towards  the  implementation  and  enforcement  of  the 
WTO  framework  in  its  bilateral  and  multilateral  contacts,  including  bilateral  Free  Trade 
Agreements (FTAs), in particular as regards the protection of intellectual property rights. 

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http://ec.europa.eu/enterprise/enterprise_policy/inter_rel/tec/index_en.htm  
http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/archives_en.htm, 30.11.2007. 

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3. 

MAKING SCIENCE DELIVER FOR EUROPEAN PATIENTS 

3.1. 

Supporting Pharmaceutical Research 

Research and Development in life sciences is a key to pharmaceutical innovation. However, 
Research  and  Development  investment  has  gradually  been  relocating  from  Europe  to  the 
United States and Asia. While certain factors are sector-specific others also relate to broader 
factors such as fiscal policy, cost of labour or education and training. 

The Commission recognises the crucial role pharmaceutical research and development plays. 
It is currently implementing various sector-specific initiatives to foster innovation in this field. 
In  2006,  the  7th  Research  and  Development  Framework  Programme  (FP729)  and  the 
Competitiveness  and  Innovation  Programme  (CIP30)  were  adopted  to  support  not  only  the 
development of new technologies, but also to ensure the early commercialisation of scientific 
findings. 

The Commission will also in its planned Communication on rare diseases for the end of 2008 
look  into  how  it  could  strengthen  its  research  and  development  efforts  in  relation  to  rare 
diseases. 

The  Innovative  Medicines  Initiative  (IMI31)  is  a  key  measure  to  strengthen  Europe’s 
competitiveness  in  biopharmaceutical  research  and  development.  The  objective  of  this  new 
instrument, an industry-Commission public-private partnership, is to enhance and  accelerate 
medicine development so as to make new treatment options available to patients earlier. 

3.2. 

Keeping the Pace: New Horizons in Medicine 

New technologies and therapies such as tissue engineering or nanomedicines and innovative 
information  and  communication  technology  (ICT  or  eHealth)  tools  for  healthcare  are 
emerging. They often lie at the borderline between various fields (medicines, medical devices, 
transplantation, ICT). Their emergence emphasises the importance of the proportionality and 
flexibility of the regulatory framework. 

The  Commission  is  committed  to  incorporating  scientific  breakthroughs  into  the  EU 
pharmaceutical framework of the 21st century like tissue engineering and gene therapy and its 
translation  into  marketable  products,  in  particular  in  areas  with  unmet  medical  needs,  e.g. 
infectious  diseases  (like  tuberculosis,  HIV/AIDS)  and  rare  diseases  which  do  not  only  pose 
public  health  challenges  for  Europe  but  also  for  developing  countries,  particular  in  sub-
Saharan Africa. All new technologies must however be evaluated properly. It is particularly 
important that the ethical pluralism and the principle of subsidiarity are fully respected. 

3.2.1.  Realising the promises of regenerative medicine 

Regenerative  medicine,  i.e.  the  use  of  genes,  cells  and  tissues  to  treat  dysfunctions  or 
regenerate  parts  of  the  human  body,  offers  a  huge  potential,  notably  against  diseases  like 
Alzheimer or Parkinson which are of high prevalence in an ageing population. The new EU 

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http://cordis.europa.eu/fp7/home_en.html 
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Regulation on Advanced Therapies32 should speed-up the development of these products and 
foster industry's competitiveness, while respecting national prerogatives on ethics. 

Objective  #24:  The  effects  of  the  implementation  of  the  Regulation  on  Advanced 
Therapies should be assessed and reviewed by 2012.  

3.2.2.  Towards more personalised medicines 

With  the  emergence  of  new  technologies  like  pharmacogenomics  and  patient-specific 
modelling  and  disease  simulators,  personalised  medicine  is  now  on  the  horizon.  In  the  long 
term, doctors may be able to use genetic information to determine the right medicines, at the 
right dose and time. This field is already affecting companies' business strategies, the design 
of clinical trials and the way medicines are prescribed. Although it is too early to say whether 
‘-omics’ technologies will indeed revolutionize the sector, the Commission closely monitors 
the area and will reflect on how it can support its development. 

In addition, it has to be assumed that the high costs of these new treatment options are likely 
to put strains on public healthcare budgets. The deliberations in the Pharmaceutical Forum on 
matters related to pricing and reimbursement have set the ground to address these issues. 

Objective #25: A report on the use of ‘-omics’ technologies in pharmaceutical research and 
development should be submitted by 2010 and the subject as to whether new Community 
instruments are needed to support their development should be explored with stakeholders. 

4. 

CONCLUSION 

The  Commission  firmly  believes  that  in  today's  globalised  world  and  security  environment, 
Europe needs a dynamic and competitive pharmaceutical sector. The EU has major assets to 
meet  this  objective:  a  strong  research  base,  a  renowned  education  system  and  skilled 
workforce, a well-established and innovative EU-based industry. 

The  future  of  the  sector  will  be  shaped  by  structural  factors,  some  of  which  go  beyond  the 
sole  pharmaceutical  area.  Nevertheless,  the  Commission  underlines  the  major  role  that  EU 
policy can play in this sector. Community action is most appropriate to tackle the challenges 
that  Member  States  have  in  common.  The  commitment  of  all  actors  involved  in  the 
implementation  of  this  Communication  will  be  essential  to  achieve  the  intended  vision:  a 
competitive industry that generates safe, innovative and accessible medicines. 

Based  on  the  objectives  outlined  in  the  Communication,  the  Commission,  therefore,  invites 
the other institutions to engage in a constructive dialogue on the way forward. 

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