COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT REPORT Accompanying the documents Proposal for a Regulation of the European Parliament and of the Council on the supplementary protection certificate for medicinal products (recast) and Proposal for a Regulation of the European Parliament and of the Council on the supplementary protection certificate for plant protection products (recast) and Proposal for a Regulation of the European Parliament and of the Council on the unitary supplementary protection certificate for medicinal products, and amending Regulation (EU) 2017/1001, Regulation (EC) No 1901/2006 as well as Regulation (EU) No 608/2013 and Proposal for a Regulation of the European Parliament and of the Council on the unitary supplementary protection certificate for plant protection products
Date: 2023-04-27
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: European patent, market approval, medicinal product, pharmaceutical legislation, plant health legislation, plant health product

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 27.4.2023  SWD(2023) 119 final  COMMISSION STAFF WORKING DOCUMENT  EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT REPORT  Accompanying the documents Proposal for a Regulation of the European Parliament and of the Council on the supplementary protection certificate for medicinal products (recast) and  Proposal for a Regulation of the European Parliament and of the Council on the supplementary protection certificate for plant protection products (recast) and Proposal for a Regulation of the European Parliament and of the Council on the unitary supplementary protection certificate for medicinal products, and amending Regulation (EU) 2017/1001, Regulation (EC) No 1901/2006 as well as Regulation (EU) No 608/2013 and  Proposal for a Regulation of the European Parliament and of the Council on the unitary supplementary protection certificate for plant protection products   {COM(2023) 221 final} - {SEC(2023) 172 final} - {SWD(2023) 117 final} - {SWD(2023) 118 final}  
 
 
Executive Summary Sheet 

Impact assessment on a reform of the EU’s supplementary protection certificates (SPC) regime, 
including  a  proposal  for  a  Regulation  creating  a  procedure  for  the  centralised  examination  of 
SPC applications, and a proposal for a Regulation creating a unitary SPC. 

Why? What is the problem being addressed?  

A. Need for action 

Supplementary  protection  certificates  (SPCs)  are  specific  intellectual  property  (IP)  rights  that 
extend  by  up  to  5  years  the  20-year  term  of  patents  related  to  medicinal  or  plant  protection 
products (PPP). 

They  aim  to  offset  the  loss  of  effective  patent  protection  due  to  the  compulsory  and  lengthy 
testing required in the EU to obtain regulatory marketing authorisation for these products.  

The relevant EU legislation is: 

  Regulation (EC) 469/2009 on SPCs for medicinal 
  Regulation (EC) 1610/96 on SPCs for plant protection products. 

Between 25 and 81 SPC applications were filed annually per EU country and more than 26,000 
national  SPCs  have  been  granted  since  1993.  The  average  duration  of  SPC  protection  is 
estimated to be 3.5 years. 

The Commission’s Intellectual Property action plan of November 2020 (COM(2020)760 final), 
building  on  the  SPC  evaluation  (SWD(2020)  292  final),  highlighted  the  need  to  tackle  the 
remaining fragmentation in the EU’s IP system, which leads to complex and costly procedures.  

The  plan  noted  that,  for  medicinal  products  and  plant  protection  products,  SPC  protection  is 
only  available  at  national  level.  At  the  same  time,  there  is  a  single  procedure  for  granting 
European patents, as well as a single set of rules for obtaining marketing authorisations.  

In  the  same  vein,  the  Pharmaceutical  Strategy  for  Europe  (COM(2020)761  final)  emphasised 
the importance of investment in R&D to provide innovative medicines, while stressing that the 
differences  across  EU  countries  in  implementing  IP  regimes,  especially  for  SPCs,  lead  to 
duplications and inefficiencies. These affect the competitiveness of the pharmaceutical industry. 
Both the EU Council1 and the European Parliament2 have called on the Commission to fix these 
deficiencies. 

Of particular importance for this impact assessment is the unitary patent (UP) system expected 
to  enter  into  force  in  2023.  It  will  allow  for  a  single  patent  covering  all  participating  EU 
countries  in  a  unitary  manner.  Alongside  it,  the  new  Unified  Patent  Court  will  allow  for 
centralised  litigation  for  participating  countries.  However,  without  this  policy  initiative  for 
SPCs, there would not be a corresponding unitary SPC to accompany (extend) unitary patents. 

The key problems this initiative aims to tackle are:  

1.  legal uncertainty about SPC status, 
2.  cumbersome monitoring of SPCs, 

1 Council conclusions on IP policy of 10 November 2020 https://www.consilium.europa.eu/media/46671/st-
12750-2020-init.pdf 
2 European Parliament, Committee on Legal Affairs, Report on an intellectual property action plan to support 
the EU’s recovery and resilience (2021/2007(INI)), https://www.europarl.europa.eu/doceo/document/A-9-
2021-0284_EN.html  

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3.  the high cost and burden of seeking and maintaining SPC protection in the EU. 

To obtain SPC protection in the whole EU for the maximum term of 5 years, applicants need to 
comply  with  27  different  procedures  at  national  patent  offices  and  pay  various  national 
application and maintenance fees totalling €192,000.  

Due to these divergent granting practices at national level, the outcome of national procedures 
is uncertain, including a lack of uniformity both in the length and outcome of the examination. 
Historically  around  a  quarter  of  applications  relating  to  the  same  product  have  resulted  in 
different decisions. 

Generic  and  biosimilar  producers,  as  well  as  public  buyers  in  the  healthcare  sector,  face 
difficulties  in  ascertaining  the  status  of  SPC  protection  in  due  time.  For  producers  this  may 
hamper the launch of competing generic or biosimilar products, or their participation in tenders 
for the purchase of medicines.  

For  national  authorities,  this  creates  problems  in  procuring  medicines,  especially  jointly  with 
other EU countries. 

What is this initiative expected to achieve?  

The general objective of the proposed policy measures is to improve the availability of (i) novel 
medicinal products for EU patients and (ii) plant protection products for agriculture, as well as 
to incentivise firms to develop those products in the EU. 

In  connection  with  the  general  objectives  and  the  problems  identified  earlier,  3  specific 
objectives have been defined: 

(1)  Increase  the  predictability  and  legal  certainty  of  SPC  protection  in  the  EU.  This  specific 
objective can be obtained by: i) facilitating substantive examination procedures; (ii) facilitating 
involvement of affected third parties; (iii) facilitating granting procedures. 

(2) Facilitate the monitoring of SPCs in the single market, preferably by offering a single point 
of access to information about the status of SPCs in the EU (e.g. whether they have been filed, 
granted, refused, invalidated, renounced or withdrawn), as well as access to structured data on 
the subject. 

(3)  Reduce  the  cost  and  burden  of  seeking  and  maintaining  SPC  protection,  by  investigating 
possible  administrative  cost  reductions;  improve  access  to  procedures  for  all  stakeholders, 
especially small and medium-sized firms. 

What is the value added of action at the EU level?  

EU-level  action  would  increase  the  integrity  of  the  single  market  by  providing  for  a 
unitary/centralised, balanced and transparent SPC system in the EU, and mitigating the negative 
consequences faced by applicants as a result of the diverging procedures.  

Hence, action at EU level is also justified to ensure the smooth functioning of the single market 
for innovative products that are subject to marketing authorisations, and to permit the benefits 
of an efficient industrial property framework to be reaped in the relevant product markets.  

B. Solutions 

What  legislative  and  non-legislative  policy  options  have  been  considered?  Is  there  a 
preferred choice or not? Why?  

  Option 0: No policy change (baseline scenario). 

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  Option 1: Guidelines for applying the current SPC regimes. This would give national 

patent offices common guidelines/recommendations for applying the existing SPC 
Regulation, building on their experience and case law from the Court of Justice of the EU. 
Such guidelines would also recommend common rules for publishing SPC information in 
national registers and ensuring it is accessible. 

  Option 2: Mutual recognition of national decisions. It would enable SPC applicants to file 
an SPC application with a designated national patent office – the “reference office” – whose 
decision would be recognised by all other national patent offices. 

  Option 3: Centralised filing and examination of SPC applications resulting in a non-

binding opinion. This would create a central authority for filing SPC applications in the EU, 
which would examine applications and issue an opinion on whether to grant an SPC or not. 
National patent offices would be free to either follow this opinion or conduct their own 
examination. Therefore, the decision on granting SPC protection would be kept at national 
level. Only holders of a European patent – and, for medicinal products, a centralised 
marketing authorisation – could benefit from this system. 

  Option 4: Centralised filing and examination of SPC applications, resulting in a binding 
opinion. This is identical to option 3, but national patent offices would have to follow the 
opinion. Therefore, while decisions on granting SPC protection would still be taken by 
national offices, the outcome of these decisions would be determined by a central authority. 

  Option 5: A ‘unitary SPC’ complementing the unitary patent. The central authority, in 
addition to examining applications, would grant a so called “unitary SPC” to applicants 
holding a European patent with unitary effect. The unitary SPC would be valid only in the 
territory of the (currently 17) EU countries participating in the UP system. 

Options  2  to  5  would  allow  third  parties  (e.g.  generic  producers  in  pharmaceutical  or 
agrochemical  sectors,  as  well  as  public  buyers  in  the  healthcare  sector)  to  influence  the  SPC 
examination process through written observations.  

Any EU language could be used to (electronically) file applications and observations. Similarly, 
the outcome of the centralised SPC examination will be published in all languages in a single 
(options 3 to 5) and searchable database.  

When  vesting  an  institution  with  SPC  responsibilities,  the  following  candidates  have  been 
considered:  the  European  Patent  Office,  the  EU  Intellectual  Property  Office,  the  European 
Medicines Agency and the European Food Safety Authority.  

The considered options would not replace national SPCs, but rather provide for an alternative 
route for obtaining SPC protection across the EU. 

The preferred choice is a combination of options 4 and 5.  

This  would  provide  for  a  centralised  procedure  that  would  result  in  the  granting  of  national 
SPCs in some or all EU countries and/or a unitary SPC (covering those EU countries in which 
the basic unitary patent has effect).  

It  is  proposed  that  the  EU  Intellectual  Property  Office  (EUIPO)  should  become  the  central 
examination authority. 

Who supports which option?  

The  combination  of  options  4  and  5  was  considered  to  offer  the  most  balanced  and 
proportionate approach, also taking into account of the views and concerns of stakeholders. 

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Regarding  the  options  set  out  in  the  call  for  evidence,  there  was  overall  support  for  an  EU 
initiative  that  would  comprise  a  combination  of  the  unitary  SPC  and  a  centralised  granting 
procedure. Though national procedures should still exist alongside them.  

Some stakeholders took the view that a single granting mechanism alone may not be sufficient 
to tackle the problems identified. Respondents further highlighted the need for the system to be 
transparent.  

In  particular,  some  stakeholders  emphasised  that  there  was  a  need  for  a  balanced  system  and 
that the initiative should not shift the current balance between generics and originators.  

What are the benefits of the preferred option (if any, otherwise main ones)?  

C. Impacts of the preferred option 

The  preferred  option  would  address  the  3  identified  problems  (i.e.  high  costs  and  burden  of 
seeking  and  maintaining  SPC  protection,  legal  uncertainty  and  cumbersome  monitoring  of 
SPCs).  

It would: 

i) Increase predictability and legal certainty in the single market regarding SPC protection, by 
eliminating  the  possibility  of  divergent  national  decisions  on  SPC  protection  across  the  EU. 
That  would  be  achieved  through  unitary  SPC  protection  for  the  EU  countries  participating  in 
the UP system and through a binding opinion by the examination authority about the validity of 
the SPC in the non-participating EU countries; 

ii)  Significantly  decrease  the  cost  of  monitoring  SPC  protection  across  the  EU  and  therefore 
boost transparency, since such information would be publicly available through a single access 
point (a website with search functions). 

iii) Significantly decrease the cost and burden of seeking SPC protection in the EU, as it would 
simplify  the  SPC  procedure  and  reduce  the  current  cost  generated  by  launching  up  to  27 
national SPC procedures.  

For  instance  a  5-year  long  SPC  protected  across  the  EU  would  cost  55%  less  than  in  the 
baseline scenario, producing savings of around €137,000 per applicant.  

The  bulk  of  savings  would  result  from  the  unitary  SPC,  as  firms  would  avoid  having  to  pay 
renewal fees annually for unitary patent protection in each of the participating EU countries (17 
currently).  

In addition, the opportunity to involve a single patent agent/attorney to file and prosecution of a 
single SPC application would also lead to savings, compared to the current need to potentially 
involve up to 27 patent agents/attorneys.  

Table 1. Costs and savings to applicants for receiving EU27-wide, 5-year long SPC protection (options 4+5) 

Filing fees 
Maintenance fees for 5 years 
Translation costs 
Agent/attorney’s fees 
Total 

€ per applicant 

Savings compared to the 
baseline 

38,800 
71,900 
 0 
2,000 
112,700 

-30,000 
111,100 
4,000 
52,000 
137,100 

Source: In-house estimates, numbers rounded to 100s. 

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What are the costs of the preferred option (if any, otherwise main ones)?  

It could be claimed that a more efficient and coherent SPC system could, indirectly, adversely 
affect  access  to  less expensive generic or biosimilar equivalents.  Based on historical  data, the 
estimated  additional  expenditure  to  healthcare  systems  during  the  additional  period  of 
protection could reach up to 0.48% in Latvia, while being negligible for many other countries 
(e.g. Luxembourg, Belgium, and Italy).  

The  revenue  from  application  and  maintenance  fees  that  could  be  lost  by  the  national  patent 
offices  (as  some  SPCs  will  no  longer  submitted  via  the  national  route)  is  estimated  at  up  to 
0.4% of their budgets – but their operating costs might be also reduced.  

Attorneys  representing  clients  before  national  patent  offices  might  see  their  revenues  drop  by 
around €2,000 per case, with the overall loss depending on the number of EU countries where 
the centralised SPC is chosen instead of the national route. 

How will businesses, SMEs and micro-enterprises be affected?  

Small  and  medium-sized  firms  are  expected  to  benefit  from  lower  SPC  application  and 
maintenance  fees  (up  to  55%  cheaper),  which,  together  with  other  savings  (attorneys, 
translations, etc.), would equate to around €137,000 per applicant for a given product. 

Smaller generic and biosimilar firms should also benefit from easier access to SPC information, 
allowing  for  better  market  monitoring  and  business  planning  (expected  to  affect  around  300 
firms annually, with savings of up to €40,000 per firm). 

Will there be significant impacts on national budgets and administrations?  

For EU countries participating in the UP system– except Malta (data not available) – the total 
additional health budget spending would amount to €37 million a year.  

If  the  above  cost  for  public  healthcare  budgets  was  re-invested  in  R&D  by  innovative 
companies, the option would produce a cost-neutral outcome. 

The possible revenue losses by national patent offices (maximum €0.5 million per EU country) 
are the corollary of applicants’ savings, depend on the demand for the unitary/centralised SPC 
and will be mostly compensated by a reduction in the workload.  

Will there be other significant impacts?  

There are no other significant impacts expected. 

When will the policy be reviewed?  

D. Follow-up 

The  first  evaluation  report  should  be  completed  5  years  after  the  entry  into  effect  of  the  first 
SPC granted through the new central procedure. 

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