COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE EVALUATION of the Regulation (EC) No 469/2009 of the European Parliament and of the Council concerning the supplementary protection certificate for medicinal products, and Regulation (EC) No 1610/96 of the European Parliament and of the Council concerning the creation of a supplementary protection certificate for plant protection products
Date: 2020-11-25
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: innovation, intellectual property, market approval, medicinal product, pharmaceutical legislation, plant health product, public health, research and development

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   EUROPEAN COMMISSION  Brussels, 25.11.2020  SWD(2020) 293 final  COMMISSION STAFF WORKING DOCUMENT  EXECUTIVE SUMMARY OF THE EVALUATION  of the Regulation (EC) No 469/2009 of the European Parliament and of the Council concerning the supplementary protection certificate for medicinal products, and Regulation (EC) No 1610/96 of the European Parliament and of the Council concerning the creation of a supplementary protection certificate for plant protection products  {SWD(2020) 292 final}  
 
 
Evaluation of Regulation (EC) 469/2009 concerning the supplementary protection 
certificate for medicinal products, and Regulation (EC) 1610/96 concerning the 
creation of a supplementary protection certificate for plant protection products 

EXECUTIVE SUMMARY 

1. 

BACKGROUND 

This  evaluation  concerns Regulations 469/2009  and 1610/96 on supplementary protection 
certificates (SPCs). It is relevant to the analysis of pharmaceutical incentives called for by 
the  June  2016  Health  Council1.  Its  findings  will  feed  into  the  implementation  of  the 
intellectual property action plan and the pharmaceutical strategy for Europe.  

SPCs  are  intellectual  property  rights  that  may  extend  by  up  to  5.5  years  the  protection 
conferred by a patent on a medicinal or plant protection product (PPP). 

The objectives identified in the intervention logic underpinning the Regulations are to: 

(1)  encourage  global  R&D  in  the  field  of  new  active  ingredients  of  medicines  and 

PPPs; 

(2)  attract R&D centres and jobs to the EU and prevent R&D relocation; 

(3)  promote a uniform SPC system in the EU.  

This evaluation relies on legal and economic studies as well as on several surveys.  

2. 

MAIN FINDINGS 

As regards the effectiveness of the SPC Regulations in achieving their objectives: 

  SPCs promote innovation and the availability of new medicines and PPPs, as they help 

companies recoup their R&D investments.  

  SPCs promote R&D in Europe to some extent. The EU remains a hub for R&D in the 
fields of pharmaceuticals and PPPs despite strong global competition. However, R&D 
location  also  depends  on  other  factors  such  as  the  local  availability  of  skilled  labour, 
public  funding  and  tax  schemes.  Patents  and  SPCs  may  be  especially  helpful  in 
supporting innovative EU pharmaceutical SMEs, which have fewer resources to embark 
on lengthy development cycles. 

  Although  the  SPC  regimes  provide  a  common  framework  within  the  EU,  they  are 
administered  at  national  level.  This  causes  fragmentation,  leading  to  high  costs  and 
imposing  an  administrative  burden  on  applicants  (especially  SMEs)  and  national 
administrations. It also leads to legal uncertainty, as the scope of protection can differ 
across the EU. This has a negative impact on SPC users and generic makers.  

  The  negative  effects  of  fragmentation  are  amplified  by  a  lack  of  transparency, 
especially  from  a  cross-border  perspective,  making  it  difficult  to  trace  what  SPC 

1   https://www.consilium.europa.eu/en/press/press-releases/2016/06/17/epsco-conclusions-balance-

pharmaceutical-system/ 

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protection  exists  for  which  products  in  which  Member  States.  This  affects  both  SPC 
holders and generics manufacturers.  

As regards efficiency, the SPC system appears to be reasonably balanced. SPCs may delay 
the  market  entry  of  generic  medicines  and  PPPs,  which  may  negatively  affect  the 
accessibility and affordability of medicines and PPPs. (For a sample of 232 medicines, we 
estimate that the SPC protection adds 13% of gross profits during the first 12.5 years after 
market launch). However, this negative effect is offset by the need for companies to recover 
investments in R&D, amid a steady increase in timelines and the costs of developing new 
products, and rising global competition. Moreover, SPC protection affects only a fraction of 
all medicines and PPPs. In many cases it is not the last protection to expire.   

The SPC system remains relevant today for the following reasons. 

 

Its three objectives remain of major political importance.  

  The COVID-19 crisis highlights the need for Europe to have a strong pharmaceutical 
sector, and for that sector to  remain  a  world  leader in  innovation  and manufacturing. 
While SPCs are granted without any condition regarding the place where the protected 
medicine  is  to  be  developed  and  manufactured,  we  have  found  examples  of  SPCs 
supporting manufacturing location decisions.  

  The  SPC  system  has  supported  major  technical  developments  in  the  pharmaceutical 
and  PPP  fields  that  have  emerged  since  1992,  such  as  biotechnology  techniques. 
However,  as  the  SPC  is  an  incentive  based  on  extending  a  period  of  exclusivity  of 
sales, the current SPC regime is not expected to be efficient in encouraging research in 
areas  with  low  commercial  viability,  such  as  medicines  for  orphan  and  paediatric 
conditions.  

The SPC Regulations are  internally  coherent, and the CJEU has progressively refined its 
case law on the most disputed provisions. The Regulations are also coherent with the future 
unitary patent, and with regulatory legislation on pharmaceuticals and PPPs, notably: 
 

the  EU  Bolar  exemption2,  which  applies  to  patents  and  SPCs  for  pharmaceutical 
products, despite divergences in national implementation; and 

 

the  legislation  on  orphan  and  paediatric  rewards,  although  a  recent  evaluation  found 
that the national granting of the SPC paediatric extension entails legal uncertainty. 

The  SPC  regime,  being  defined  at  EU  level,  creates  EU  added  value  through  the  broad 
uniformity  of  the  incentives  it  provides,  despite  some  fragmentation  resulting  from  their 
national implementation.  

3. 

CONCLUSIONS 

The  SPC  Regulations  appear  to  support  research  on  new  active  ingredients  and  to  have 
remained  fit  for  purpose;  they  are  coherent  with  the  patent  and  related  pharmaceutical 
legislation,  and  have  brought  EU  added  value.  However,  it  is  challenging  to  establish  a 
clear link between SPC protection and the location of R&D, as other factors play a role.  

The  fact  that  SPCs  are  nationally  administered  and  managed  undermines  the 
effectiveness and efficiency of the SPC system. This is the system’s main shortcoming. 

2   Article 10(6) of Directive 2001/83/EC and Article 41 of Regulation (EU) 2019/6.  

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It creates legal uncertainty, red tape and extra costs for businesses, especially SMEs. Purely 
national examination and grant procedures also entail extra costs and administrative burden 
for national administrations.  

In  addition,  the  overall  transparency  of  the  SPC  system  is  suboptimal,  especially  in  a 
cross-border  perspective.  This  is  detrimental  to  innovators  and  generics  manufacturers 
alike. 

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