COMMISSION STAFF WORKING DOCUMENT Subsidiarity Grid 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) 117 final  COMMISSION STAFF WORKING DOCUMENT Subsidiarity Grid 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) 118 final} - {SWD(2023) 119 final}  
 
 
1.  Can the Union act? What is the legal basis and competence of the Unions’ intended action? 

1.1 Which article(s) of the Treaty are used to support the legislative proposal or policy initiative? 

The  package  of  four  legislative  proposals  intended  to  reform  the  supplementary  protection 
certificate (SPC) regime includes: 

 

 

two  recast  Regulations  (for  medicinal  and  plant  protection  products  respectively)  based  on 
Article 114(1) of the Treaty on the Functioning of the EU (TFEU), which empowers the European 
Parliament and the Council to adopt measures for the approximation of the provisions laid down 
by  law,  regulation  or  administrative  action  in  Member  States,  which  have  as  their  object  the 
establishment and functioning of the internal market, and  

two Regulations (for medicinal and plant protection products respectively) based on Article 118, 
first  sentence,  of  that  treaty,  which  empowers  the  European  Parliament  and  the  Council  to 
establish measures for the creation of European intellectual property rights throughout the EU, 
including  the  setting  up of  centralised  Union-wide  authorisation, coordination and  supervision 
arrangements. 

Article 118 therefore provides an express legal base for EU-wide intellectual property rights. It is also 
the  legal  basis  for  Regulation  (EU)  1257/2012  of  the  European  Parliament  and  of  the  Council 
implementing enhanced cooperation in the area of the creation of unitary patent protection.   

1.2 Is the Union competence represented by this Treaty article exclusive, shared or supporting in 
nature? 

In the case of both Article 118(1) and Article 114(1) TFEU, the Union’s competence is shared.  

Subsidiarity does not apply for policy areas where the Union has exclusive competence as defined in 
Article  3  TFEU1.  It  is  the  specific  legal  basis  which  determines  whether  the  proposal  falls  under  the 
subsidiarity  control  mechanism.  Article  4  TFEU2  sets  out  the  areas  where  competence  is  shared 
between the Union and the Member States. Article 6 TFEU3 sets out the areas for which the Union has 
competence only to support the actions of the Member States. 

2.  Subsidiarity Principle: Why should the EU act? 

2.1 Does the proposal fulfil the procedural requirements of Protocol No. 24: 

-  Has there been a wide consultation before proposing the act? 
- 

Is there a detailed statement with qualitative and, where possible, quantitative indicators 
allowing an appraisal of whether the action can best be achieved at Union level? 

The  Commission  conducted  a  public  consultation  in  the  course  of  the  SPC  evaluation  (between 12 
October  2017  and  4  January  2018).  In  addition,  the  Max  Planck  Institute  (MPI)  study  mentioned 
below  included  a  survey  among  stakeholders  in  the  EU  Member  States  (2017),  conducted  by  the 
Allensbach Institute  (hereinafter  'the Allensbach survey'), which included several questions relating 
to  the  operation  of  the  current  (national)  SPC  regimes.  Moreover,  from  8  March  to  5  April  2022 
interested parties could provide feedback to Commission’s Call for Evidence. 

1 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:12008E003&from=EN  
2 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:12008E004&from=EN  
3 https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:12008E006:EN:HTML  
4 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:12016E/PRO/02&from=EN  

1 

 
 
 
 
                                                           
Both  the  explanatory  memoranda  of  the  proposals  and  the  common  impact  assessment  report 
(chapter 3) contain a section on the principle of subsidiarity. 

2.2 Do the explanatory memoranda (and impact assessment) accompanying the Commission’s 
proposals contain an adequate justification regarding the conformity with the principle of 
subsidiarity? 

Yes.  The  explanatory  memoranda,  which  summarise  Chapter  3  of  the  Impact  assessment  report, 
explain  that  1)  the  two  recast  proposals  are  based  on  Article  114(1)  TFEU  which  is  the  same  legal 
basis already used for Regulations (EC) No 469/2009 and (EC) No 1610/96 and 2) for the two unitary 
SPC  Regulations,  only  Article  118(1)  TFEU  can  be  applied  for  the  creation  of  European  intellectual 
property titles.  

Despite  the  fact  that  SPCs  are  already  harmonised  by  EU  law,  there  are  still  cases  where  some 
Member  States  have  granted  SPCs  while  identical  applications  have  been  refused  in  others,  or 
granted  with  a  different  scope.  SPC  applicants  currently  face  diverging  decisions  across  the  EU 
concerning  the  same  product  at  hand,  while  incurring  costs  for  applying  and  maintaining  SPCs  in 
several Member  States. National publication practices  also vary across Member States, resulting in 
poor  transparency,  which  can  be  harmful  e.g.  to  generics  makers  or  follow-on  manufacturers. 
Consequently,  further  EU  intervention  is  needed  to  address  these  issues  and  can,  unlike  national 
intervention  by  Member  States,  ensure  a  coherent  EU-wide  framework,  as  well  as  ease  the  total 
costs and burden of fees to be paid in multiple Member States. 

The  unitary  SPC  will  be  an  autonomous  regime  created  by  EU  Regulations,  just  as  the  Community 
design system of 2002 (and the corresponding current proposal for a regulation for EU designs) and 
the  EUTM  under  Regulation  (EU)  2017/1001.  An  EU  IP  right  (such  as  a  unitary  SPC)  can  only  be 
created  by  the  EU,  and  national  legislation  cannot  achieve  this  objective,  as  it  cannot  provide  for 
unitary  protection  throughout  the  Union.  Moreover,  a  bundle  of  national  SPC  in  the  enhanced 
cooperation area of the unitary patent would not give full continuation of the unitary effect of the 
unitary patent in that area.  

2.3 Based on the answers to the questions below, can the objectives of the proposed action be 

achieved sufficiently by the Member States acting alone (necessity for EU action)? 

The  identified problems to be  solved by the  present package initiatives  have a strong cross-border 
(single  market)  dimension  and  the  objectives  pursued  by  the  SPC  initiative  can  therefore  not  be 
sufficiently  achieved  by  the  Member  States  acting  alone.  Despite  the  fact  that  SPCs  are  already 
harmonised  by  EU  law,  there  are  still  cases  where  some  Member  States  have  granted  SPCs  while 
identical applications have been refused in others, or granted with a different scope. SPC applicants 
thus face diverging decisions across the EU concerning the same application at hand, while incurring 
costs  for  applying  and  maintaining  SPCs  in  several  Member  States.  The  above  is  particularly 
burdensome  for  follow-on  companies  that  need  to  monitor  SPC  status  across  many  jurisdictions. 
National publication practices also vary across Member States. Consequently, further EU intervention 
is needed to address these issues and can, unlike national intervention by Member States, ensure a 
coherent framework, as well as ease the current burden of applications and renewal fees to be paid 
in  several  Member  States.  Thus,  EU  action  is  needed  to  set  up  a  centralised  procedure  for  the 
granting of SPCs. 

Moreover, unitary SPCs, as any other unitary intellectual property rights, can only be created at EU 
level (in accordance with the two Regulation proposals under Art. 118 TFEU). The unitary SPC is an 
autonomous IP right, applying independently of any national system. Therefore, EU action is needed 

2 

 
 
 
for the creation of this new IP right. 

(a)  Are there significant/appreciable transnational/cross-border aspects to the problems being 

tackled? Have these been quantified? 

The key problems that have been identified as regards this initiative are: 1. Legal uncertainty about 
SPC status; 2. Cumbersome monitoring of SPC status by third parties; and 3. High cost and burden of 
seeking and maintaining SPC protection in the EU.  

These  problems  result  from  the  purely  national  implementation  of  the  SPC  regime;  i.e.  they  are 
caused by divergent national practices for application and grant of SPCs, as well as insufficient and 
patchy  information  on  the  SPC  status  in  each  EU  country.  Although  common  eligibility  criteria  are 
defined  in  the  SPC  Regulations,  around  one  in  four  SPC  applications  covering  the  same  product 
resulted in divergent decisions in Member States (in respect of 740 products approved between 2004 
and  2014  and  referring  to  the  same  basic  patent).  Moreover,  the  problems  should  be  seen  in  a 
general context of globally competitive pharmaceutical and PPP sector with increasingly cross-border 
value chains.  

(b)  Would national action or the absence of the EU level action conflict with core objectives of 

the Treaty5 or significantly damage the interests of other Member States? 

The absence of an EU level action would conflict with the core objective laid down in Article 3 of the 
Treaty,  which  is  to  establish  an  internal  market  and  to  work  for  the  sustainable  development  of 
Europe  based  on  balanced  economic  growth  and  price  stability,  and  a  highly  competitive  social 
market economy.  

(c)  To what extent do Member States have the ability or possibility to enact appropriate 

measures? 

The required modernisation, improvement and streamlining of the existing SPC regimes, exclusively 
implemented at  a national level,  cannot  be  achieved  by Member States  but  requires Union action. 
Not all MS may have the resources to examine all granting criteria: according to the 2018 study by 
the Max Planck Institute for Innovation and Competition (MPI), national patent offices (NPOs) of 15 
Member States do not use the exemption from verifying all substantive criteria (CZ, DE, DK, FR, HR, 
HU, IE, IT, LT, LV, NL, PL, PT, SE, SK), while other Member States do.  

Moreover, as regards the unitary SPC, an extension of the unitary patent by national SPCs would not 
be  able to give  rise to  a continued unitary effect. A unitary  right,  such as a unitary  SPC, cannot  be 
created by Member States alone. 

(d)  How does the problem and its causes (e.g. negative externalities, spill-over effects) vary 

across the national, regional and local levels of the EU? 

The  current  landscape  of  EU  SPC  law  is  characterised  by  a  range  of  diverging  decisions  taken  by 
national  patent  offices.  Although  common  eligibility  criteria  are  defined  in  the  SPC  Regulations, 
around  one  in  four  SPC  applications  covering  the  same  product  resulted  in  divergent  decisions  in 
Member States (in respect of 740  products approved between 2004 and 2014 and referring to the 

5 https://europa.eu/european-union/about-eu/eu-in-brief_en  

3 

 
 
                                                           
same basic patent).  

Moreover, the duration of the grant procedure may vary between MS, taking for instance 17 months 
in  FR  to  31  months  in  DE.  Last,  the  ratio  of  rejection  per  Member  State  differs  considerably:  on 
average, five countries (CY, EE, FI, IT, LU) reject fewer than 5% of applications while 6 countries (DK, 
ES, MT, NL, PL, SE) reject more than 15%, providing another example of the current inconsistencies 
observed in the current, national SPC granting procedure. 

(e)  Is the problem widespread across the EU or limited to a few Member States? 

As  follows  from  the  information  provided  for  under  point  (d),  the  problems  identified  affect  all 
Member States. 

(f)  Are Member States overstretched in achieving the objectives of the planned measure? 

No, as the proposed measures would create a new centralised procedure and a new unitary IP right 
at  EU  level.  These  new  measures  would  not  need  to  be  transposed  by  Member  States,  and 
participation in the  new  procedure by national patent  offices would be on a voluntary  basis. Work 
undertaken in the course of these procedures would also need to be financially compensated by the 
central authority operating the new regime. 

(g)  How do the views/preferred courses of action of national, regional and local authorities 

differ across the EU? 

Both  the  Council6  and  the  European  Parliament7  have  called  on  the  Commission  to  fix  the  current 
inefficiencies of the SPC system. As regards Member States, the meeting of the Commission expert 
Group  on  Industrial  Property  Policy  (GIPP)  on  18  November  2022  was  dedicated  solely  to  the  SPC 
reform.  

Several Member States shared their preliminary positions regarding the policy options presented in 
this  impact  assessment  in  the  meeting,  and/or  in  written  contributions  in  advance.  Among  the  17 
Member States who took a preliminary position, a clear majority (11) supported PO5 – a unitary SPC 
to  complement  the  unitary  patent.  Regarding  the  current  national  SPC  framework,  the  Member 
States  taking  the  floor  agreed  that  the  current  SPC  fragmentation  is  a  problem.  To  solve  this 
fragmentation, some called solely for guidelines (PO1), others for a centralised procedure and/or a 
unitary  SPC.  Among  those  recognising  the  need  for  a  centralised  procedure,  more  Member  States 
opted for PO4, where the examination opinion is binding on national authorities (8 Member States), 
than for PO3, where it is not binding (5 Member States).  

6 Council of the European Union, Intellectual property policy and the revision of the industrial designs system in 
the Union, Council conclusions (10 November 2020), 12339/20 
(https://www.consilium.europa.eu/media/46671/st-12750-2020-init.pdf) 
7 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) 

4 

 
 
                                                           
2.4 Based on the answers to the questions below, can the objectives of the proposed action be 
better achieved at Union level by reason of scale or effects of that action (EU added value)? 

The current SPC system was created by, and thus can only be changed via, EU Regulations.  

(a)  Are there clear benefits from EU level action?  

Yes. EU-level action would enhance the integrity of the internal market by providing for a centralised, 
balanced  and  transparent  SPC  system  in  the  EU  and  mitigate  the  negative  consequences  resulting 
from  redundant  and  potentially  diverging  procedures  that  applicants  face.  Hence,  by  its  nature, 
action  at  EU  level  is  also  justified  to  ensure  the  smooth  functioning  of  the  internal  market  for 
innovative medicinal products subject to marketing authorisations, and to permit the benefits of an 
efficient  industrial  property  framework  to  be  reaped  in  the  relevant  product  markets,  both  by 
innovative and follow-on manufacturers.  

Based on its current average coverage (20 Member States) and duration (3.5 years), SPC protection 
of a given product would cost around EUR 98 500 on average. In order to cover all 27 Member States 
for 5 years one should pay nearly EUR 192 000 in total – not including any fees that would be charged 
by patent attorneys or law firms. The introduction of a centralised examination procedure, and of a 
unitary SPC in particular, will allow for cost savings in this regard. 

Currently,  it  is  very  costly  and  burdensome  for  follow-on  manufacturers  (e.g.  generics  makers)  to 
assess  the  status  of  SPC  protection  for  a  given  product  throughout  the  EU  and  they  may  need  to 
monitor up to 27 SPCs per each product. The information relating to this product may be dispersed 
across various IT systems, formats and linguistic regimes, thus making it much more cumbersome to 
enter the generic/biosimilar market, especially for SMEs. 

Last, only an EU level action would allow a unitary patent to be extended in a unitary way, namely by 
the new unitary SPC. 

(b)  Are there economies of scale? Can the objectives be met more efficiently at EU level (larger 

benefits per unit cost)? Will the functioning of the internal market be improved? 

The proposed centralised procedure for the granting of national certificates, also able to result in the 
granting  of  a  unitary  certificate,  on  the  basis  of  a  single  application  that  would  undergo  a  single 
examination  process,  will clearly  result  in  economies  of  scale  compared  to  the  current  situation  in 
which multiple national applications for certificates need to be filed and examined separately in each 
Member State where protection is sought, in respect of a given product. This current situation entails 
duplication of work and results in high costs, poor transparency and poor legal certainty. This impacts 
not only innovative firms developing products eligible for SPC protection, but also makers of follow-
on  products  such  as  generic  medicines.  This  initiative  will  clearly  contribute  to  improving  the 
functioning of the internal market in the pharmaceutical and agrochemical sectors.  

(c)  What are the benefits in replacing different national policies and rules with a more 

homogenous policy approach? 

The  completion  of  the  single  market  in  the  area  of  will  create  greater  legal  certainty,  resulting  in 
lower  costs  and  administrative  burden  for  innovative  firms,  and  in  better  transparency  and  legal 
certainty  for  third  parties  such  as  generics  makers  –  which  will  indirectly  benefit  consumers,  and 
particularly patients.  

5 

 
 
The proposed centralised procedure for the granting of national and/or unitary certificates covering 
several  Member  States  will  make  it  easier  and  less  costly  for  innovative  firms  to  obtain  SPC 
protection across the Union, including through the combined use of national and unitary certificates. 
This will also increase predictability, help firms reduce costs in managing multinational IP portfolios, 
and make it easier and cheaper for makers of follow-on products to assess SPC status across the EU. 
The  Union-wide  approach  implemented  by  the  centralised  procedure  will  also  ensure  that  the 
applicable  rules  and  procedures  are  consistent  across  the  Union,  ensuring  legal  certainty  for  all 
relevant market participants. 

(d)  Do the benefits of EU-level action outweigh the loss of competence of the Member States 
and the local and regional authorities (beyond the costs and benefits of acting at national, 
regional and local levels)? 

Yes.  Competence  in  the  area  of  SPCs  will  continue  to  be  a  shared  one,  as  the  existing  national 
avenues for the granting of certificates will not be removed. The proposed completion of the single 
market in the area of SPCs through the introduction of a centralised procedure and the creation of 
unitary SPCs promises to bring about substantial economic benefit for both innovators and makers of 
follow-on  products.  National  offices  will  also  be  able  to  participate  in  the  new  centralised 
examination procedure and receive remuneration for the tasks done in this capacity.     

(e)  Will there be improved legal clarity for those having to implement the legislation? 

It  is  expected  that  the  new  procedure  and  the  unitary  SPC  will  lead  to  improved  legal  clarity,  in 
particular  compared  to  the  current  fragmentation  owed  to  diverging  decisions  undertaken  by 
national patent offices.  

3.  Proportionality: How the EU should act 

3.1  Do the explanatory memoranda (and any impact assessment) accompanying the Commission’s 
proposals contain an adequate justification regarding the proportionality of the proposals and 
a statement allowing appraisal of the compliance of the proposals with the principle of 
proportionality? 

Yes.  

As  stated  in  the  explanatory  memorandum  of  each  of  the  proposals,  the  initiative  does  not  go 
beyond what  is necessary to achieve the identified objectives. Its scope  is limited to those  aspects 
that Member States cannot achieve satisfactorily on their own, and where Union action can produce 
better  results.  For  example,  in  terms  of  consistent  decisions  on  SPC  applications,  reduction  of 
administrative burden and costs, and improving legal certainty as well as transparency. 

Moreover, the impact assessment in its section 7.4 assesses the compliance of the options with the 
proportionality  principle.  It  further  explains  that  the  options  considered  provide  a  mix  of  Member 
State  and  EU  level  actions  with  gradual  increase  of  the  EU  level  intervention.  Possible  legal 
instruments for implementing policy options are in the case of PO1 a set of recommendations; and in 
the case of PO2-5 an amendment (or recasting) of the existing SPC regulations.  

6 

 
 
3.2 Based on the answers to the questions below and information available from any impact 
assessment, the explanatory memoranda or other sources, is the proposed action an 
appropriate way to achieve the intended objectives? 

The  proposed  action  in  form  of  the  four  proposals  is  clearly  an  appropriate  way  to  achieve  the 
objectives. It cannot be envisaged to introduce a centralised procedure or a unitary SPC in any other 
way. 

(a)  Is the initiative limited to those aspects that Member States cannot achieve satisfactorily on 

their own, and where the Union can do better? 

Yes. 

(b)  Is the form of Union action (choice of instrument) justified, as simple as possible, and 

coherent with the satisfactory achievement of, and ensuring compliance with the objectives 
pursued (e.g. choice between regulation, (framework) directive, recommendation, or 
alternative regulatory methods such as co-legislation, etc.)? 

Since  the  current  SPC  regime  is  already  governed  by  Regulations,  no  other  instrument  can  be 
envisaged for this initiative.  

(c)  Does the Union action leave as much scope for national decision as possible while achieving 
satisfactorily the objectives set? (e.g. is it possible to limit the European action to minimum 
standards or use a less stringent policy instrument or approach?) 

Yes. It is foreseen that under certain conditions the centralised procedure has to be used in order to 
reduce the risk for national discrepancies (e.g. as soon as certain criteria are met, such as holding a 
European  patent  and,  for  medicinal  products,  a  centralised  marketing  authorisation),  but  national 
applications  will  not  be  abolished.  Member  States’  national  patent  offices  will  also  be  able  to 
participate  in  the  centralised  examination  procedure,  resulting  in  the  granting  of  national  SPCs 
and/or unitary SPCs.  Moreover, as regards the granting of a national SPCs on the basis of the new 
centralised procedure, a MS may deviate from the binding centralised examination opinion in certain 
cases, and moreover the validity of such a SPC may still be challenged before a national court – i.e. a 
certain degree of national autonomy will be preserved.  

(d)  Does the initiative create financial or administrative cost for the Union, national 

governments, regional or local authorities, economic operators or citizens? Are these costs 
commensurate with the objective to be achieved? 

This proposal will have no impact on the EU budget, since the system will remain fully self-funded (by 
applicants’ fees). The EUIPO as the new examination authority will implement the new proposal. The 
necessary set-up costs related to the tasks conferred to the Office, including the costs of new digital 
systems, will be financed from the Office’s accumulated budgetary surplus.  

National  Offices  would  see  a  diminished  workload  as  regards  national  applications  and  a  loss  in 
income  from  application  fees (for  a  breakdown,  see  Annex 5F of  the  impact  assessment),  but  may 
choose  to  participate  in  the  examination  procedure  in  exchange  for  remuneration.  Additionally,  a 
system  of  financial  transfers  should  be  set  up  to  compensate  for  these  losses.  In  light  of  these 
aspects, the financial burden created on NPOs is proportionate with the objectives to be achieved. 

SPC  applicants  will  benefit  from  cost  reduction  compared  to  the  baseline:  currently,  costs  are  on 

7 

 
 
average 98 500 EUR for 20 Member States for a duration of 3.5 years. To cover all 27 Member States 
for 5 years, this would cost 192 000. These numbers do not yet include agents or attorney fees. The 
introduction of a centralised examination procedure, and of a unitary SPC in particular, will allow for 
cost savings, creating a reduction in financial or administrative costs for applicants. 

(e)  While respecting the Union law, have special circumstances applying in individual Member 

States been taken into account? 

Given that SPCs are already harmonised by EU law, there are not special circumstances that would 
apply in this regard for individual Member States. While certain Member States currently make use 
of  the  exception  provided  for  in  Article  10(5)  of  Regulation  (EC)  No  469/2009,  namely  that  not  all 
granting criteria of Article 3 of those Regulations would need to be examined, national patent offices 
from those Member States may still participate in the centralised examination (albeit just one such 
examiner per panel). 

Last,  the  unitary  SPC  will  only  be  able  to  extend  a  unitary  patent  in  those  Member  States 
participating in the unitary patent system (17, initially). 

8