COMMISSION STAFF WORKING DOCUMENT Subsidiarity Grid Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act)
Date: 2025-12-16
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: biotechnology, competitiveness, consumer protection, foodstuff, foodstuffs legislation, innovation, medical research, pharmaceutical industry, public health, single market

EN 

  EN 

   EUROPEAN COMMISSION  Strasbourg, 16.12.2025  SWD(2025) 1055 final  COMMISSION STAFF WORKING DOCUMENT Subsidiarity Grid Accompanying the document Proposal for a   REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) {COM(2025) 1022 final}  
 
 
Subsidiarity Grid 

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 general objective of this Regulation is threefold: (i) to improve the functioning of the internal 
market by establishing a framework to strengthen the competitiveness of the health biotechnology 
sector, from research to production, (ii) to create the conditions for the development and timely 
placing  on  the  Union  market,  of  biotechnology  innovations,  products  and  services,  (iii)  while 
safeguarding  high  standards  for  the  protection  of  human  health,  animal  health,  patients  and 
consumers, and the environment, ethics, quality, food and feed safety, and biosecurity.  

The appropriate legal basis is therefore as follows:  

•  Article 114 of the Treaty on the Functioning of the European Union (‘TFEU’) which allows 
the  Union  to  take  measures  that  increase  harmonisation  and  remove  fragmentation  to 
create a level playing field within, and fully exploit the scale of, the Union single market, so 
that the health biotechnology and biomanufacturing sectors can thrive. In accordance with 
Article 114(3) TFEU, the proposal seeks to achieve the objective of a high level of health and 
safety protection. 

•  Article 168(4)  TFEU, which  mandates the Union to contribute to the  achievement a high 
level of human health protection through the adoption - in order to meet common safety 
concerns  -  of  (i)  measures  setting  high  standards  of  quality  and  safety  of  organs  and 
substances of human origin, blood and blood derivatives; (ii) measures in the veterinary and 
phytosanitary fields which have as their direct objective the protection of public health; and 
(iii) measures setting high standards of quality and safety for medicinal products and devices 
for medical use. 

•  Article 173(3) TFEU which allows the Union to decide on specific measures in support of 
action  taken  in  the  Member  States  to  ensure  the  conditions  necessary  for  the 
competitiveness  of  the  Union’s  industry,  excluding  any  harmonisation  of  the  laws  and 
regulations of the Member States. This article provides the legal basis for up an EU health 
biotechnology investment facility, setting establishing the framework basis for future Union 
financial  support  together  with  implementing  partners,  to  support  the  financing  of,  and 
investments in, companies and projects falling within the scope of the European Biotech 
Act.  

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

In these areas the Union’s competence is shared with the Member States.  
The proposal respects Member States’ exclusive competences, such as in the provision of health 
services. 

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 

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  

1 

 
 
 
 
 
between the Union and the Member States. Article 6 TFEU3 sets out the areas for which the Unions 
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? 

Extensive stakeholder consultations were carried out in view of the preparation of the proposal.  

•  A call for evidence (14 May - 11 June 2025) gathered 222 valid individual contributions from a 
wide  range  of  stakeholders:   business  associations5  (63),  companies  (50),  non-governmental 
organisations (NGOs) (44), academic and research institutions (20), public authorities in the EU 
(14), EU-citizens (14) and other categories (17).  

• As part of the public authorities, one had an international scope, 8 had a national scope, 

and five had a regional scope.  

•  A public consultation (4 August - 10 November 2025) collected a total of 359 contributions. The 
contributions  considered  for  the  analysis6  were  submitted  by  91  companies/businesses,  61 
business  associations,  47  NGOs,  44  academic/research  institutions,  54  EU  citizens,  9  non-EU 
citizens, 21 public authorities, 2 trade unions, 2 consumer associations, and 1 environmental 
organisation7, while 27 additional respondents identified themselves as ‘Other’.  

• As part of the public authorities, 8 had a national remit and 8 a regional scope, 2 were 

local authorities and 3 were international organisations. 

• A strong majority of respondents to the public consultation agreed that biotechnology and 
biomanufacturing  products  can  positively  impact  the  EU  economy  and  the  society,  also 
recognizing its contribution to the environment.  

•  Targeted consultation activities have been conducted, including in the context of an external 
study. announced in the Commission Communication ‘Building the future with nature: Boosting 
Biotechnology and Biomanufacturing in the EU’ (Action 1)8.  

•  Consultation activities related to the analysis of regulatory problems and challenges faced 
by the biotechnology sector, and on the mapping of applicable EU and national legislations 
to biotechnologies (interviews, surveys and workshops). 

•  For the analysis of the impacts of identified policy provisions, evidence on their impacts 
has  been  collected.  On  clinical  trials,  evidence  has  been  collected  through  interviews, 
surveys  and  workshops.  Evidence  on  the  impacts  of  options  on  genetically  modified 
microorganisms has been collected through interviews. 

The Explanatory Memorandum contains a section on the principle of subsidiarity. 

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  
5 3 respondents that selected trade unions are analysed together with business associations 
as representing the industry. 
6 4 trade unions were analysed under business associations. 
7 In the statistics, the 2 trade unions, 2 consumer organisations and the environmental organisation are 
reflected with the respondents who identified themselves as ‘other’. 
8 Communication from the Commission to the European Parliament, the Council, the European Economic and 
Social Committee and the Committee of the Regions, Building the future with nature: Boosting Biotechnology 
and Biomanufacturing in the EU, COM(2024) 137 final. 

2 

 
 
 
 
2.2 Does  the  explanatory  memorandum  (and  any  impact  assessment)  accompanying  the 
Commission’s proposal contain an adequate justification regarding the conformity with the 
principle of subsidiarity? 

The objectives of the proposal cannot be achieved by Member States acting alone, as the issues 
tackled  are  of  a  cross-border  nature  and  are  not  limited  to  single  Member  States  or  to  several 
Member States. The proposed actions focus on areas where there is a demonstrable value added in 
acting at Union level due to the scale, speed and scope of the efforts needed.   

Furthermore, the drivers identified are shared across the Member States, affecting the functioning 
of the single market and the global competitiveness of European companies. Moreover, access to 
finance is scattered across the EU and EU companies lack the capacity to access private finance at a 
competitive  scale,  including  at  later  stages  of  development.  Similarly,  European  biotechnology 
clusters are scattered across the EU, without sufficient continental scale to compete globally. The 
development and deployment of AI solutions for biotechnology remains limited, also due to the low 
level of storage, access and sharing of data relevant for biotechnology in the EU, including across 
borders. Lastly, there is also a clear need across the EU to attract, reskill and upskill the workforce.  

Moreover, while several Member States have taken action to boost innovation  in biotechnology, 
the above-mentioned bottlenecks persist; improvements are expected to take considerably more 
time and without achieving the levels needed to compete at global level. For example, access to 
finance  would remain scattered at EU  level. The growth of clusters in the EU would also remain 
limited, without sufficient benefits from cross-border connections. 

Finally, important regulatory barriers faced by European biotechnology companies stem from Union 
legislation.  Therefore,  with  a  view  to  enable  the  effectiveness  of  the  substantive  measures  put 
forward in this proposal, it is proposed to simplify Union legislation in the area of health and of food 
and feed safety to make it easier to innovate and place biotechnology products and services on the 
Union market and to enhance legal clarity.   

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  proposed  measures  aim  at  tackling  two  main  drivers,  i.e.  the  complexity  of  the  regulatory 
frameworks  leading  to  slow  time  to  market  in  comparison  to  a  rapidly  evolving  and  high-risk 
biotechnology  sector,  as  well  as  the  fragmentation  in  the  biotechnology  and  biomanufacturing 
enablers, resulting in difficulties for EU stakeholders to scale-up.  
The  regulatory  drivers  are  likely  to  persist  without  intervention.  Given  that  they  stem  from  EU 
legislations, national action would not be relevant and EU action is more appropriate. The market 
drivers are not expected to be sufficiently tackled through national action. Member States will still 
be able to take complementary action and their competences are respected.  

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

tackled? Have these been quantified? 

First, important regulatory barriers faced by European biotechnology companies stem from Union 
legislation, including authorization procedures at EU level. In the health area especially, given that 
diseases do not know borders, these common EU provisions constitute a cross-border issue that 
affect all Member States and can be streamlined at EU level.  
Second,  the  market  drivers  identified  are  shared  across  the  Member  States  (see  section  2.2.), 
affecting  the  functioning  of  the  single  market  and  the  global  competitiveness  of  European 
companies. The proposed Act ensures the smooth functioning of the internal market in the health 

3 

 
 
 
 
 
biotechnology and biomanufacturing sector, while maintaining a high level of protection of health 
and of the environment. 

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

the Treaty9 or significantly damage the interests of other Member States? 

The proposed regulatory changes concern measures directly affecting the internal market as regards 
biotechnology products. The proposed changes concern legislation at EU. Absence of EU level action 
would  not  allow  to  address  the  regulatory  complexities,  uneven  interpretations  and  high  costs 
stemming from EU legislation, which are likely to persist without intervention. Therefore, national 
action would not be relevant and EU action is more appropriate. 

With  regards  to  EU  industrial  policy  measures,  whilst  several  Member  States  have  taken  action, 
challenges and barriers persist. Improvements in this policy area are expected to take considerably 
more time and without achieving the levels needed to compete at global level, thus compromising 
the overall objective of ensuring the  functioning of  the  internal market  and support  the Union’s 
competitiveness. 

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

measures? 

First,  Member  States’  ability  to  enact  national  measures  is  limited  to  the  areas  framed  in  the 
amended legislations. 
Second, Member State can continue to develop national policies on the enabling factors to R&D and 
the industrial base in their countries; the proposal does not affect their competences in these areas 
(e.g. access to finance, education, etc.).  
The proposal also respects Member States’ exclusive competences, such as in the provision of health 
services. 

(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 problems and drivers have been observed across the national, regional and local levels of the 
EU.  
This includes the regulatory barriers stemming from EU legislation, which are similar in all Member 
States given that the related fields have been harmonised. 
The  drivers  hindering  the EU  biotechnology  and  biomanufacturing  sector  (e.g.  access  to  finance, 
skills,  taxation,  etc)  are  also  similar  in  all  Member  States.  These  challenges  might  however  have 
different intensities in different Member States and at regional and local levels. 

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

First, biotechnology and biomanufacturing can be carried out anywhere in the EU. 
Second,  the  driver  related  to  the  complexities  of  the  regulatory  frameworks  has  a  clear  EU 
dimension as they are caused by shortcomings in the existing Union legislation.  
Third, the drivers related to the fragmentation in the biotechnology and biomanufacturing enabler 
factors have been observed across the EU.  

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

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

4 

 
 
 
 
First, the first Pillar of the proposed Act aims at making the EU regulatory framework streamlined 
and  fit-for-purpose  for  the  rapidly  evolving  biotechnology  and  biomanufacturing  sector.  In  this 
context, the proposed Act is expected to allow Member States to perform their implementation and 
enforcement tasks in a more cost-efficient and consequently a more proportionate manner. 
Second, with regards to EU industrial policy measures, Member States will incur costs related to the 
implementation  of  certain  measures  however  these  are  expected  to  be  proportionate  with 
objectives being achieved. 

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

differ across the EU? 

There is an overall strong support from Member States to reinforce the EU health biotechnology 
and biomanufacturing, and to ensure patients and users can benefit from innovations placed on the 
EU market. In September 2025, EU Member States urged the Commission to unlock the potential of 
biotechnologies,  by  reducing  fragmentation  and  simplifying  the  EU  regulatory  framework  across 
policy areas10. 

2.4 Based on the answer 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)? 

A large market with a streamlined and fit-for-purpose regulatory framework is the best possible way 
to support biotechnology to reach the market. It also ensures the same level of the protection health 
and of the environment across the Union.  
Coordinated  action  at  EU  level  on  the  enabling  factors  for  a  competitive  EU  biotechnology  and 
biomanufacturing sector, are expected to yield higher benefits than national measures to ensure 
the smooth functioning of the EU single market. Stakeholders will be equipped with targeted tools 
to  for  biotechnology  and  biomanufacturing  to  efficiently  scale-up.  These  respect  national 
competences. 

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

A large market with a streamlined and fit-for-purpose regulatory framework is the best possible way 
to support biotechnology to reach the market. It also ensures the same level of the protection health 
and of the environment across the Union.  
Furthermore,  comprehensive  coordinated  action  at  EU  level  on  the  enabling  factors  for  a 
competitive EU biotechnology and biomanufacturing sector in the integrated single market (e.g. the 
set-up of strategic projects at EU level), are expected to yield higher benefits than national measures 
at lower scale. 

(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 development of biotechnology and biomanufacturing is costly, therefore it is more cost-efficient 
for  operators  to  operate  in  a  larger  market  with  uniform  regulatory  frameworks.  The  measures 
streamlining and clarifying the regulatory framework and reducing administrative burden will allow 
to place products on the market in shorter time best achieve this objective through action at EU 
level. 
The measures supporting the enabling factors for biotechnology and biomanufacturing in the EU 
aim at enhancing the functioning of the EU Single Market, which can be met more efficiently at EU 
level.  

10 Council of the European Union, A call for action on life sciences for the Union's competitiveness - Council 
conclusions (approved on 30 September 2025) (13323/25) 

5 

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

homogenous policy approach? 

The first pillar of the proposal focuses on the EU regulatory frameworks. Although the covered areas 
are already harmonised at EU level, the proposed Act  aims at streamlining and clarifying already 
existing  Union  legislation,  also  addressing  the  observed  diverging  national  interpretations  or 
additional national requirements, hampering the smooth functioning of the internal market. The 
other  measures  aim  at  equipping  the  EU  with  targeted  tools  to  for  biotechnology  and 
biomanufacturing to efficiently scale-up. 

(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)? 

The first Pillar of the proposal will amend existing Union legislation. Member States will keep the 
competences as the implementation and enforcement of the planned measures. 
The  additional  measures  aim  at  ensuring  the  smooth  functioning  of  the  Single  Market  and  the 
competitiveness of the EU through complementary action at EU level. These objectives cannot be 
sufficiently achieved through national measures. National competences are not impacted. 

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

The first Pillar specifically addressed the implementation challenges of the amended EU legislation. 
The additional measures will apply to the whole Single Market and will provide stakeholders with 
the tools and enhanced predictability to operate in the EU. 

3.  Proportionality: How the EU should act 

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

The selected measures under the industrial policy and substantive part of the proposal are targeted 
at the specific areas of interventions listed below:   

•  The provisions on strategic health biotechnology projects and high-impact strategic health 
biotechnology projects are proportionate to the aims pursued, including by recognising the 
first category of projects at Member State level, and the second category at Union level on 
the  basis  of  an  assessment  at  Member  State  level.  Moreover,  the  recognition  of  such 
projects  is  based  on  clear  criteria  tailored  to  ensure  that  projects  that  contribute 
substantially  to  the  Union’s  competitiveness,  resilience,  and  security  fall  within  the 
enhanced  support  regime.  Moreover,  the  recognition  of  such  projects  does  not  restrict 
Member States’ ability to support additional projects through other instruments. Member 
States  benefit  from  flexibility  as  regards  the  authorities  that  they  intend  to  designate  to 
recognise strategic health biotechnology projects and assess applications for high-impact 
strategic health biotechnology projects. This flexibility  also applies to the single points of 
contact  and  the  provision of  administrative,  technical,  and  financial  support,  in  line  with 
Union  law  and  the  national  systems.  Accelerated  permitting  timelines  apply  only  to 
recognised  projects  and  are  designed  to  streamline  procedures  without  lowering  any 
environmental, health or safety standards.  
Similarly, measures aimed at supporting networking among health biotechnology clusters 
are  limited to  what  is  necessary  to  foster  synergies  in  the  internal  market,  while  the EU 

• 

6 

 
 
Health  Biotechnology  Support  Network  is  aiming  to  build  on  existing  national  and  EU 
structures wherever possible.  

•  On access to funding, the interventions focus on measures mobilising public funding and 

private capital; public funding needs to be in line with State aid rules.  

•  The proposed interaction modalities with Member States in the context of a Steering Group 
allows  for  priorities  to  be  adjusted,  including  by  ensuring  that  the  support  measures  for 
strategic  health  biotechnology  project  and  high-impact  strategic  health  biotechnology 
projects remains closely aligned with the Regulation’s general objective.  

The proposed amending provision aimed at reducing the time-to-market of biotechnology products 
and services focus on certain sectoral Union legislation where room for simplification of regulatory 
and  administrative  complexities  has  been  identified.  Simplification  relates  to  changes  that  are 
necessary with a view to secure the effectiveness of the substantive provisions put forward in this 
proposal  and  will  improve  the  legal  clarity,  certainty,  and  overall  efficiency of the  concerned  EU 
legislative frameworks.   

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

The initiative does not go beyond what is necessary to achieve the objectives of the proposal and is 
appropriate to achieve them. The choice of the legal instrument is justified. The proposal respects 
and does not modify the competences of Member States. 

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

their own, and where the Union can do better? 

As  indicated  in  question  2.3.,  the  first  pillar  of  the  proposal  aims  at  streamlining  and  clarifying 
existing  Union  legislation,  also  addressing  the  observed  diverging  national  interpretations  or 
additional national requirements that hamper the smooth functioning of the internal market. Action 
at EU level is therefore more appropriate than national interventions and the proposal does not go 
beyond what is necessary to achieve this objective. 
Moreover, the other pillars of the  proposed Act  aim at addressing  the market drivers identified. 
Whilst several Member States have taken action, the absence of coordinated action at EU level is 
not expected to bring  fast  improvements  and at the necessary levels to compete at global level. 
National action would not be sufficient to achieve the objective general and specific objective of the 
proposal. 

(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.)? 

The proposal takes the form of a Regulation of the European Parliament and of the Council.  

A regulation is the most suitable legal instrument for Pillars 1 to 4, given the need for a uniform 
application  of  the  new  rules,  in  particular  the  conditions  and  procedure  for  recognising  heath 
biotechnology strategic projects and high-impact health biotechnology strategic projects, and for 
their administrative, technical and financial support, and also more broadly for companies and non-
profits active in the relevant biotechnology sectors across the internal market. This is also the case 
for Pillar 5, regarding the provisions on biotechnology health products, given that they aim to ensure 
a dialogue and more flexibility across the Union legislative frameworks in the area of health. The 
choice of a regulation as a legal instrument is also appropriate for pillar 6 because only a regulation, 

7 

 
 
 
with its directly applicable legal provisions, can provide the necessary degree of uniformity needed 
to boost EU biodefence and biosecurity and prevent biotechnology misuse. 

In  all  cases,  the  choice  of  the  instrument  is  justified  considering  that  the  pillar  7  establishes 
provisions  amending  several  existing  Union  regulations  in  the  area  of  health  and  food  and  feed 
safety. 

Lastly, a regulation is appropriate for the provisions regarding on evaluating this Regulation which 
do not need to be transposed through national measures and are directly applicable. 

(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 og approach?) 

The first pillar of the proposal has an internal market component, and therefore it leaves limited 
scope for national action in order to ensure the smooth functioning of the internal market. Member 
States’  ability  to  enact  national  measures  remains  limited  to  the  areas  framed  in  the  amended 
legislations and is unchanged. 
With regards to the other pillars, Member States can develop complementary national, regional and 
local policies to support biotechnology and biomanufacturing, including in the areas covered by the 
act, based on their needs. 
The  proposal  does  not  modify  the  repartition  of  competences  between  the  Union  and  Member 
States. 

(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? 

For the Union level, without prejudice to the outcome of the negotiations on the next MFF proposal, 
strategic health biotechnology projects and strategic health high-impact biotechnology projects may 
be  supported  by  Union  programmes,  funds  and  financial  instruments,  in  accordance  with  the 
objectives set out in the regulations establishing those funds and programmes. 

For the national and regional level, authorities might incur costs related to establish single points of 
contact with adequate staff and provide administrative support to project promoters for the permit 
granting procedures of Health Biotechnology Strategic Projects. 

Costs are expected to be commensurate to the benefit that countries and regions are expected to 
receive  from  streamlined,  more  coherent  procedures  and  improved  coordination,  reducing 
duplication of administrative work, and supporting more consistent regulatory decisions across the 
Union, as well as, from the investment that strategic health biotechnology projects, the strategic 
health  high-impact  biotechnology  projects  and  the  EU  investment  facility  might  attract  in  the 
respective countries (e.g. establishment of biomanufacturing infrastructures, set up and growth of 
start-ups and scaleups with subsequent economic value and employment generation). 

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

States been taken into account? 

The proposed measures enabling biotechnology and biomanufacturing to scale-up in the Union aims 
at complementing national initiatives. Member States will continue to be able to take action in these 
areas, taking into account the diversity of their national biotechnology industry. 

8 

 
 
 
 
9