COMMISSION STAFF WORKING DOCUMENT Summary of the replies to the public consultation on Supplementary Protection Certificates and patent research exemption for sectors whose products are subject to regulated market authorisations Accompanying the document Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products
Date: 2018-05-28
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: administrative formalities, export (EU), market approval, medicinal product, pharmaceutical legislation, public health, single market

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 28.5.2018  SWD(2018) 242 final  COMMISSION STAFF WORKING DOCUMENT Summary of the replies to the public consultation on Supplementary Protection Certificates and patent research exemption for sectors whose products are subject to regulated market authorisations Accompanying the document Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products {COM(2018) 317 final} - {SEC(2018) 246 final} - {SWD(2018) 240 final} - {SWD(2018) 241 final}  
 
 
1. 

INTRODUCTION 

The Single Market Strategy, adopted in October 2015, announced that the Commission would 
‘consult,  consider  and  propose  further  measures,  as  appropriate,  to  improve  the  patent 
system  in  Europe,  notably  for  pharmaceutical  and  other  industries  whose  products  are 
subject to regulated market authorisations’. 

In  particular,  the  Strategy  aimed  to  explore  a  recalibration  of  certain  aspects  of  patent  and 
supplementary  protection  certificate  (SPC)  protection,  and  announced  that  this  recalibration 
could comprise the following three elements: (1) the creation of a European SPC title, (2) an 
update  of  the  scope  of  EU  patent  research  exemptions,  and  (3)  the  introduction  of  an  SPC 
manufacturing waiver. 

Accordingly, an online public consultation was conducted from 12 October 2017 to 4 January 
2018.  Its  outcomes  are  summarised  below.  Comprehensive  information  on  this  public 
consultation  can  be  found  at  https://ec.europa.eu/info/consultations/public-consultation-
supplementary-protection-certificates-spcs-and-patent-research-exemptions_en. 

2. 

PARTICIPATION 

The consultation included a set of six specific sub-questionnaires for the following groups of 
stakeholders:  (I)  general  public,  (II)  originators  industry/associations,  (III)  generics  and 
biosimilars  industry/associations,  (IV)  health  authorities/doctors/patients  groups,  (V)  patent 
offices/practitioners, and (VI) industry/trade authorities. 

A total of 231 replies were provided to the on-line consultation: 43 replies from the general 
public,  71  from  originators  industry/associations,  63  from  generics  and  biosimilars 
industry/associations, 15 from health authorities/doctors/patients groups (mostly from national 
organisations  dealing  with  health  insurance/reimbursement/health  technology  assessment, 
from  a  doctors’  organisation,  and  2  from  patients’  associations),  34  from  patent 
offices/practitioners, and 5 from industry/trade authorities. 

Therefore,  the  largest  category  of  respondents  was  innovative  pharmaceutical  companies 
(‘originators’, most of whom were SPC-holders), with 71 respondents, of whom 44 are based 
in the Union. The second largest category was generics/biosimilars organisations/companies, 
with 63 respondents, 51 of whom are based in the Union. 

Amongst  originators,  it  may  be  noted  that  15  of  the  71  respondents  declared  to  also  own  a 
separate branch or business activity that develops or markets generics and/or biosimilars.  

Most firm respondents have their headquarters in the Union, except for 16 firms that are based 
mainly in Switzerland, Asia and USA. 

Both  innovators  and  generics  respondents  are  mostly  global  players.  Regarding  generics 
respondents, 33 respondents have a world-wide activity, 13 have EU- only activities and 4 are 
limited to their national domestic market. Regarding originators respondents, 31 respondents 
have  world-wide  activities,  8  have  EU-  only  activities  and  6  are  limited  to  their  national 
domestic market. 

The statistics corresponding to respondents identified as SMEs or start-ups are the following: 

-  Among  the  63  respondents  defining  themselves  as  mostly  manufacturers  of 
generics/biosimilars,  12  respondents  identified  themselves  as  an  SME  and  one  as  a 
start-up; 

1 

 
-  Among  the  71  respondents  defining  themselves  as  mostly  originators,  2  respondents 
identified  themselves  as  an  SME  involved  in  medicines  biotechnology  and  one  as  a 
start-up in the field of bio-pesticides. 

In  addition,  several  pharmaceutical  associations  (Medicines  for  Europe,  EUCOPE,  and 
EuropaBio) also represent pharmaceutical start-ups and SMEs and conveyed SME views both 
by responding to the public consultation and/or by sending position papers to the Commission 
services. The input of these position papers is taken into account in this summary of replies. 

3. 

FIVE CLUSTERS OF QUESTIONS 

The  questions  of  the  consultation  can  be  clustered  into  the  following  seven  headings  (the 
question  in  the  cluster  (1)  below  was  only  addressed  to  the  general  public  (group  (I)  of 
stakeholders): 

(1) Awareness  of  the  existence  of  the  EU  SPC  system  and  its  role  in  innovation,  and 
awareness about the geographical origin of the production of the medicines consumed; 

(2) Profile of the originators and generics respondents; 

(3) Effectiveness of the EU SPC regime: the role of SPC in innovation, localisation of 

R&D and manufacturing; 

(4) Implementation of the SPC system:  the registration  procedures,  transparency  of the 

system, associated cost and enforcement aspects; 

(5) The SPC manufacturing waiver; 

(6) The unitary SPC: need for it, the grant authority, language regime, etc.; 

(7) The  scope  of  the  EU  Bolar  patent  exemption:  its  role,  national  implementation, 
covering  supply  of  active  pharmaceutical  ingredients,  coverage  of  it  by  the  Unified 
Patent Court Agreement, Bolar in the plant protection products market, availability for 
health technology assessment. 

The  following  subsections  summarise  the  replies  submitted  in  relation  to  the  groups  of 
questions above. 

3.1. 

General  questions  addressed  to  the  general  public:  awareness  of  the 
existence of the EU SPC system 

Of  the  43  replies  received  from  the  general  public,  36  respondents  from  the  general  public 
were aware of the SPC system (only 1 respondent stated not to be aware of). 34 respondents 
agree on the positive role of the SPC on pharmaceutical innovation (21 think that the SPC has 
been  positive  for  the  growth  of  the  pharmaceutical  industry  in  the  EU),  but  22  respondents 
think  that  the  SPC  is  not  enough  to  encourage  certain  categories  of  treatments  (i.e.  other 
incentives might be necessary). There is less awareness about the existence of SPCs for plant 
protection products (only 23 respondents were aware of them). 

24  respondents  are  aware  of  the  geographical  location  of  the  production  of  consumed 
medicines, and 23 care about where medicines are produced. Only 3 respondents do not care 
where medicines are produced. 

3.2. 

Profile of the originators and generics respondents 

Companies  and  organisations  who  participated  in  the  consultation  are  mostly  producers  of 
human  medicinal  products  (75%  generic  firms  or  associations  and  61%  for  innovators)  and 
veterinary  medicinal  products  (21%  generics  and  20%  innovators).  There  were  very  few 

2 

 
submissions  from  plant  protection  products  stakeholders,  but  the  main  European  originator 
generics associations in this field made submissions. 

As highlighted in section 2 above, commercial activity of most firms is worldwide (not only 
specific  for  international  firms  but  also  for  Union-based  firms  or  associations).  The 
commercial activity of more than 47% of innovators and 53% of generic firms is not limited 
to the EU market, but covers international markets. Only 17% of Union-based innovators who 
participated  in  the  consultation  and  24%  of  Union-based  generic  firms  declare  having  a 
commercial activity restricted to the EU landscape. 

Limited information is provided regarding their business structure. From those who provided 
information,  more  than  half  of  generics  firms  declare  having  more  than  90%  of  their 
manufacturing  output  (outsourced  and  not  outsourced)  located  in  the  Union.  The  other  big 
poles  where  generic  firms  concentrate  a  significant  part  of  their  manufacturing  are  China 
(16%),  the  USA  (12%)  and  India  (11%).  On  the  other  side,  generic  investments  in  clinical 
trials  and  R&D  are  reported  to  be  mostly  EU-based1.  Innovators  have  reported  little 
information on business structure, and their investment is spread worldwide, more than is the 
case  with  generics  manufacturers.  High  investments  are  reported  in  almost  all  geographical 
markets,  especially  for  investments  in  clinical  trials  and  in  R&D  in  Korea,  Japan,  the  USA 
and Canada. 

3.3. 

Effectiveness  of  the  EU  SPC  regime:  impact  on  innovation  and  indirect 
impact on generics and biosimilars 

Most innovators consider the SPC, or the possibility of obtaining one, an important factor for 
investment  decisions.  However,  as  some  companies  indicate  in  the  consultation,  investment 
decisions are the result of having the right overall ecosystem of all the relevant policies that 
foster R&D. SPCs are considered to have a proportionate impact on investment along all steps 
of  the  value  chain:  R&D,  clinical  trials,  manufacturing,  distribution  and  commercialisation. 
Some  innovators  consider  SPC  availability  as  the  main  factor  for  investment  decisions  in 
manufacturing.  However,  the  importance  that  the  majority  of  innovators  ascribe  to  SPCs  is 
moderate, as they consider that SPCs are one factor in a package of elements: aside from the 
availability of SPCs, decisions on investments in research (excluding clinical trials and field 
trials)  are  driven  by  a  combination  of  factors  such  as  access  to  high  skilled  labour  and 
recruitment of patients. With regard to the most important factors when investing in clinical 
trials, innovators consider health infrastructure and proximity of research universities. 

Two thirds of originator respondents, and most practitioners, confirm that in the Union, SPCs 
are  not  available  for  certain  types  of  innovation  that  require  regulatory  approval,  such  as 
medical devices; such innovations are however SPC-protected in the USA and Japan (as also 
confirmed by generics respondents). 8 innovators state that SPCs do not suffice to encourage 
them to invest in the development of antibiotics, orphan and neglected treatments. 

According to the results of the public consultation, the three main drivers which lead generic 
firms  to  invest  in  the  development  of  products  outside  the  Union  are  the  lack  of  SPC 
protection in other markets, the existence (or not) of a ‘Bolar exemption’ and the proximity of 
the export market to the manufacturing facilities. Most of them consider that Regulation (EC) 
No  469/2009  has  forced  them  to  relocate,  or  outsource  (via  licensing),  their  production 
outside the Union, to other countries where SPC protection does not exist or is weaker. They 
consider  that  supply  sources  of  active  pharmaceutical  ingredients  (‘APIs’)  have  also  been 
affected  by  the  SPC  regime.  The  main  factors  that  industry  considers  to  be  affecting  API 

1   These  findings  should  be  considered  as  anecdotal,  due  to  the  few  replies  we  have  received  in  the  public 

consultation. 

3 

 
                                                 
supply  sources  are  SPC  protection,  the  scope  of  the  Bolar  exemption,  indirect  patent 
infringement  rules  in  the  country  manufacturing  the  API,  and  compliance  with  regulatory 
standards.  A  secondary  –  but  still  relevant  –  driver  is  securing  supply.  Proximity  to 
manufacturing does not seem to be of great significance for generics when choosing their API 
sources.  However,  most  generics  manufacturers  claim  that  it  is  not  always  possible  to  find 
APIs supplied from within the Union. In contrast, they claim that, for biosimilars, R&D and 
manufacturing tends to take place at the same location. SPCs and the Bolar exemption are key 
elements  for  generics/biosimilars-related  investments,  over  labour  costs,  including  the  way 
they can source APIs.  

A  few  respondents  (from  the  health  professionals  and  patients  group)  claim  that  SPC 
protection  has  a  negative  effect  on  the  development  of  medicines  vis-à-vis  added-value  for 
patients. 

3.4. 

Implementation of the SPC system 

Respondents broadly support the way in which SPC issues are regulated at Union level, which 
is  found  to  be  globally  effective.  However,  most  respondents  claim  that  there  are  different 
practices for registration and SPC enforcement across Member States (a few originators  and 
generics manufacturers disagree). 
However,  EFPIA2  suggests  that  guidance  at  Union  level  would  improve  the  situation.  This 
should not extend to amending the SPC acquis, as EFPIA considers that such an amendment 
process could lead to years of uncertainty; generics manufacturers seem to be split on whether 
to clarify aspects of the SPC Regulation implementation via legislative amendments. 

IP practitioners (including patent offices) and generics manufacturers support this ‘guidance’ 
approach,  especially  since  court  proceedings  in  some  Member  States  may  take  too  long. 
Generics  manufacturers  mostly  support  SPC  registration  with  substantive  examination,  but 
consider that transparency is  not  optimal (information  published  by public authorities  is not 
always  comprehensive  or  up-to-date,  and  private  databases  monitoring  SPC  status  are 
expensive).  Most  respondents  do  not  see  problems  with  the  level  of  registration  fees  or 
litigation  costs  for  SPC  holders,  as  they  are  already  well  compensated  by  the  additional 
exclusive sales resulting from SPC protection. 

3.5. 

SPC manufacturing waiver 
Views expressed by generics/biosimilars manufacturers3 

Most  generics/biosimilars 
manufacturing waiver, considering that: 

(‘G/B’)  manufacturers  support 

the 

introduction  of  a 

  SPCs disadvantage EU-based G/B manufacturers compared with those based in countries 
with no SPC when exporting G/Bs outside the Union. This problem is confirmed by 56 
out of 62 G/B respondents (1 respondent denies this problem, and 2 do not know). 

  SPCs disadvantage EU-based G/B manufacturers compared with those based in countries 
with  no  SPC  when  placing  G/Bs  on  the  market  in  the  EU  immediately  after  the  SPC 
expires; this problem is confirmed by 53 out of 62 G/B respondents (3 respondents deny 
this problem, and 3 do not know). 

2   The European Federation of Pharmaceutical Industries and Associations. 
3   Questions 10, 11 and 34. Additional written information was provided by Medicines for Europe and certain 

national sister associations. 

4 

 
                                                 
  The EU SPC, in its current form, increases reliance on imports of medicines and active 

pharmaceutical ingredients from outside the Union; 

  The entry into force of the SPC Regulation in an EU country has triggered relocation to 
non-EU countries, or licensing of our manufacturing to a country with no or weaker SPC-
type protection; 

  Already  today,  it  is  not  always  possible  to  source  active  pharmaceutical  ingredients 

(‘APIs’) from within the Union; 

  The introduction of an SPC manufacturing waiver in the Union would increase G/B sales 
in  countries  outside  the  Union  when  protection  in  those  countries  expires;  would  lead 
them  to  increase  their  manufacturing  in  the  EU;  would  not  increase  the  risk  of 
infringement of SPCs in the EU; and would not significantly reduce originators’ sales in 
countries outside the Union when protection abroad expires. 

The  vast  majority  of  SMEs  manufacturing  generics  and  biosimilars  also  share  these  views, 
and in  general  consider that  the longer duration of SPCs in  the Union compared to  non-EU 
countries makes manufacturing in the Union less interesting for them. 
Views expressed by originators4 

Originators’ submissions to the consultation reflect their broad – though not overwhelming – 
opposition to the introduction of an EU SPC manufacturing waiver: 54 out of 71 originators 
do not consider that EU-based manufacturers face export or EU day-1 entry-related problems 
vis-à-vis their competitors based in non-EU countries (with shorter or no SPC protection). 

A majority of originators oppose the introduction of an SPC manufacturing waiver in the EU, 
considering  that  the  current  SPC  framework  does  not  put  EU-based  generics/biosimilars 
manufacturers  at  a  particular  disadvantage  compared  with  foreign-based  manufacturers 
(neither when exporting generics/biosimilars outside the Union nor when it comes to placing 
generics/biosimilars on the EU market after SPC protection expires), and that a waiver would: 

  increase the risk of infringement of their SPCs in the Union; 

  reduce protection to recoup their investments in R&D in the Union; 

  reduce their sales in countries outside the EU when protection abroad expires; 

  erode IPR protection, sending a negative message to those innovating and investing in the 

Union, or intending to do so; 

  increase competition from EU-based generics/biosimilars in the EU market; 

  provide  EU-based  generics/biosimilars  manufacturers  with  limited  benefits  only  (it  is 
argued that EU-based generics companies are often the first to market in the EU, and that 
SPC(-like) protection is also available in the markets of EU’s main export partners (USA, 
Japan, etc.). 

Views expressed by other stakeholders 

As  indicated  above,  a  large  majority  of  the  43  citizens  who  answered  the  consultation  state 
that  they  care  about  the  origin  of  productions  of  the  medicines  they  consume,  while  only  3 
said they do not care. 

4   Questions 22, 23, 44. Additional written information was provided by EFPIA, EUCOPE, ECPA, EuropaBio 

and certain of their national sister associations. 

5 

 
                                                 
10  out  of  15  respondents  in  the  group  of  patients/doctors/insurers  agree  that  the  EU  SPC 
system puts EU-based manufacturers of generics and biosimilars at a disadvantage vis-à-vis 
competitors  based  in  third  countries  when  it  comes  to  export.  Only  1  respondent  considers 
that this is not a problem. 6 respondents of this category see also an issue regarding timely EU 
day-1  entry  for  EU-based  manufacturers  of  generics  and  biosimilars.  3  respondents  do  not 
consider that this is a problem. 

11  Member  States  authorities  or  ministries  took part  in  the  public  consultation  and/or  made 
written  submissions.  Some  expressed  support  and  none  expressed  explicit  opposition  to  the 
idea. 

One Member State strongly endorsed the introduction of an SPC manufacturing waiver in the 
EU  for  export  and  stockpiling  purposes;  in  its  view,  it  would  also  result  in  employment 
increase in the EU pharmaceutical industry and provide additional incentives for investments 
by generics/biosimilars companies in manufacturing and R&D in the Union. In particular, this 
Member  State  would  like  to  see  a  legislative  proposal  as  soon  as  possible  introducing  the 
manufacturing waiver, separately from the other issues considered for review. 

Another  Member  State  considered  that  before  deciding  to  introduce  the  manufacturing 
waiver, a careful assessment should be made of all the impacts thereof, its proven importance, 
and the general impact of the waiver on the patent protection system as a whole. 

A further Member State considered that the introduction of an SPC manufacturing waiver in 
the EU would not prevent originators from recouping their R&D investments, and that in the 
short  term  it  would  not  significantly  reduce  their  sales  outside  the  Union  when  protection 
abroad expires. 

Most respondents from national public authorities remained silent on the issue at this time. 

3.6. 

Unitary SPC5 

A very large majority of the respondents across all categories favour the creation of a unitary 
SPC, which would extend unitary patents when such patent rights expire. 

Regarding the benefits of a unitary SPC, a great majority of originators consider that it could 
boost  the  value  of  investments,  that  it  would  reduce  red  tape  relating  to  registration  and  to 
litigation, that it would provide uniform protection across the Union as well as legal certainty, 
that  it  would  reduce  maintenance  costs,  that  it  would  offer  a  specialised  court,  and  that  it 
would make licensing easier. A large majority of generics/biosimilars (‘G/B’) manufacturers, 
including SMEs, share these views. 

One  Member State considered that it would also simplify and enhance the efficiency of the 
SPC application process. 

Opinions diverge regarding the practicalities for implementing such a new title. While some 
respondents  favour  the  grant  of  that  title  by  a  virtual  office  composed  of  national  experts 
working on behalf of an EU agency, others prefer either to entrust the EPO with this task, or 
to set up a new EU agency to do so. 

Amongst SMEs manufacturing G/Bs, half of them favour the grant of unitary SPCs by a new 
EU agency, while the other half favour the EPO for this purpose. 

5   Questions 38, 39, 40, 43 as regards originators; questions 29, 30, 31, 32, 35 as regards generics/ biosimilars 
(‘G/B’)  manufacturers  as  well  as  SMEs  manufacturing  G/Bs;  questions  27,  28,  29,  30,  34  as  regards  IP 
practitioners; also questions 9, 10, 11, 12 as regards public authorities. 

6 

 
                                                 
Concerning the  languages  to be used for a  unitary  SPC, a clear majority  favoured the EPO 
language regime (English, French, German), which is the regime that is applicable to the EU 
unitary  patent.  However,  SMEs  manufacturing  generics  and  biosimilars  prefer  the  five 
language regime of the EUIPO (English, French, German, Italian and Spanish), whilst one of 
these favours the EPO regime. 

Respondents also mostly considered that national marketing authorisations should be able 
to be used (in addition to EU marketing authorisations) as a basis for getting a unitary SPC, 
even  though  the  latter  would  then  not  be  enforceable  in  those  Member  States  where  no 
marketing  authorisation  would  have  been  granted  (through  mutual  recognition  or 
decentralisation procedure). 

In  the  absence  of  a  unitary  SPC,  a  majority  of  the  respondents  were  of  the  opinion  that 
National Patent Offices could grant – pursuant to the current legislation – national SPCs for 
products covered by future unitary patents. 

3.7. 

Bolar exemption6 

The questions of the consultation related to the Bolar patent exemption addressed a number of 
issues  previously  analysed  by  the  the  Commission  services  in  the  related  inception  impact 
assessment7,  and  for  which  the  Commission  sought  the  views  of  stakeholders,  including  in 
relation  to  options  to  address  them  (e.g.  via  legislative  amendments,  guidelines,  etc.).  The 
issues relating to the Bolar exemption are: 

-  Effectiveness of the EU Bolar exemption; 

-  Whether the Bolar patent exemptions applies in all Member States to: 

o 

o 

tests  conducted  by  originator,  generic  and  biosimilar  manufacturers  for  the 
purpose of seeking marketing authorisations in non-EU countries; 

tests conducted by pharmaceutical originators to meet new national regulatory 
requirements  on  pricing  and 
technology 
assessments,  that  compare  a  given  medicine  with  others  to  show  relative 
cost/efficacy effectiveness); 

reimbursement 

(e.g.  health 

o  supply  of  patented  active  pharmaceutical  ingredients  (APIs)  to  EU-based 
generic  manufacturers  for  the  purpose  of  seeking  marketing  authorisations 
under the Bolar patent exemption; 

o  plant protection product; 

-  Whether the future Unified Patent Court will apply the Bolar patent exemption in line 

with Member States’ practice. 

Respondents  consider  that  several  aspects  of  the  implementation  of  the  EU  Bolar  patent 
exemption  are  not  clear  in  some  Member  States  (e.g.  a  number  of  generics  manufacturers 
claimed  that  courts  in  Member  States  have  denied  the  Bolar  exemption  for  foreign 
authorisation purposes). This provokes changes in their business models: a strong majority of 
the  respondents  in  the  generics  group  states  that  they  would  increase  their  orders  for  APIs 
from  EU-based  suppliers  if  the  implementation  of  the  Bolar  exemption  were  clear  in  this 
regard. 

6   Questions  29,  34,  35,  36,  42  as  regards  originators;  questions  17,  23,  26,  33,  36  as  regards  generics/ 

biosimilars (‘G/B’) manufacturers; questions 20, 23, 24, 31 as regards IP practitioners. 

7   http://ec.europa.eu/smart-

regulation/roadmaps/docs/2017_grow_051_supplementary_protection_certificates_en.pdf 

7 

 
                                                 
Originator  submissions  support  the  development  of  guidelines  at  Union  level  on  the 
recalibration of Bolar aspects, such as exempting from patent infringement, on the one hand, 
tests  and  trials  for  the  purpose  of  fulfilling  health  technology  assessment  (‘HTA’8) 
requirements,  registering  generic  medicines  in  third  countries9,  and  registering  generic 
versions  of  pesticides  in  the  EU;  and  on  the  other  hand,  supply  of  active  pharmaceutical 
ingredients (APIs10) to generic companies. 

Several  originators  favour  the  creation  of  a  Commission-Member  States  expert  group  to 
follow  Bolar  developments.  Respondents  consider  that  the  practice  of  the  Unified  Patent 
Court  regarding  the  Bolar  exemption  should  be  compatible  with  the  broader  practices 
developed in  many  Member  States (this is  a major  concern for a significant majority of the 
originators and generics manufacturers; almost half of IP practitioners also see this risk, and 
think it is undesirable). 

It is uncertain whether the Bolar exemption is available for plant protection products. None of 
the respondents claim that this is the case11; a few state that it is not clear, and two state that it 
might be available in a few Member States. Only a minority of IP practitioners state that it is 
certainly available in their Member States. 

8   Only about half of the originators claim to have certainty on whether HTA activities are covered by Bolar in 
Member States. One claims that it moved clinical trials from a Member State due to uncertainty about Bolar 
covering HTA-related testing or not. About half of the practitioners cannot state either whether HTA-related 
testing is covered by Bolar. 

9   About  a  third  of  the  practitioners  cannot  state  whether  testing  for  foreign  registration  of  a  medicine  is 

covered by Bolar or not. 

10   Most generics manufacturers claim that it is not always possible to source APIs within the EU. 
11   Submission by ECCA (European Crop Care Association), the association representing the sector of generic 

plant protection products. 

8