EU Better Regulation

This page was last edited on at


The EU Better Regulation agenda is an approach to governing regulation. Better regulation programmes, sometimes termed ‘smart regulation’, have been adopted by many governments across the world. They vary substantially but have a common focus on regulatory quality and burden reduction, operationalised via impact assessment, evaluation, and stakeholder consultation (see below).

The Better Regulation agenda was formally introduced by the European Commission in the early 2000s with the goals of reducing unnecessary ‘red tape’ and improving the quality of EU legislation. Although similar initiatives exist at country level, this page concentrates on the EU’s Better Regulation agenda and the tobacco industry’s interest in it. Although the EU Better Regulation agenda has been reformed several times,12 its core tools remain impact assessment, evaluation, and stakeholder consultation. The underlying core aims of minimising regulatory burden, simplifying regulation, fostering wide participation, and adhering to principles of evidence-based policymaking have also remained consistent.34

The European Commission has described EU Better Regulation as:

“[create] legislation that achieves its objectives while being targeted, effective, easy to comply with and with the least burden possible”.3

While the European Commission explicitly states that the purpose of Better Regulation is to improve regulatory quality rather than deregulate, health and environmental civil society groups have expressed serious concerns about its impact on regulatory protections.567 In this context, it is notable that a concerted campaign by British American Tobacco (BAT) and other large corporations from regulated industries is deemed a contributing factor to its rise at EU level.89

What follows is a brief overview of the EU Better Regulation agenda, followed by a discussion of the tobacco industry’s interests and involvement in its development, and how it has been used to challenge public health policy that safeguards populations of health-harming practices and products.

The core pillars of Better Regulation

Although the core tools of evaluation, impact assessment, and stakeholder consultation were used prior to the introduction of Better Regulation, the EU agenda has formalised and significantly expanded their use.

Impact assessment

Ex-ante impact assessment aims to assess the potential economic, social and environmental impacts of new policy proposals and changes to existing policy.3

In 2002, the European Commission established a new ‘integrated’ impact assessment (IA) system for its initiatives, bringing together three preceding forms of IA: Business, Health, and Environmental. The European Commission’s guidelines for applying Better Regulation state that economic, social, and environmental impacts should be assessed for all initiatives which are likely to have significant impacts, including non-legislative initiatives such as action plans, strategies, as well as delegated and implementing acts. When assessing potential impacts of proposed policies, policymakers are encouraged to assign a monetary value to each predicted impact. This has prompted concerns within the public health community on the basis that business costs of regulation are often easier to predict and quantify than longer-term health or environmental benefits.10

IAs and consecutive policy decisions concerning health or the environment are often supported by a risk assessment.

Within policymaking, risk assessment is conducted (often as part of an impact assessment) to facilitate the decision about whether legislation is required to manage a particular hazard or populations’ exposure to it.4

Where the significance of a risk cannot be determined due to a lack of evidence or scientific consensus, the decision may be taken based on the precautionary principle.

The precautionary principle is an approach in which risk management action is taken when there are reasonable grounds to believe that a particular hazard may have an irrevocable impact on public health or the environment, despite scientific uncertainty.11


Evaluations which retrospectively assess the impacts of an initiative must be conducted for all significant initiatives on a rolling basis. According to the ‘evaluate first’ principle, existing legislation should also be evaluated before new policy action is taken in the same field. Fitness Checks, which are large evaluations reviewing the performance of multiple pieces of legislation within a policy area or on a specific, cross-cutting topic, are conducted more sparsely.

The regulatory fitness and performance (REFIT) programme, first launched in 2012 by the European Commission,12 aims to improve the ‘regulatory fitness and performance’ of EU legislation on a rolling basis by continuously evaluating burden reduction and simplification potential.2 The programme is supported by the Fit for Future platform (previously REFIT platform), an expert group representing member state authorities, EU Committees, and stakeholders from industry and civil society.

In 2019, the incoming von der Leyen Commission announced the introduction of a ‘one in, one out’ measure to complement the REFIT programme, with piloting underway since late 2021. It involves “offsetting new burdens resulting from the Commission’s legislative proposals by equivalently reducing existing burdens in the same policy area”.2 In practice, this means that any burdens related to applying EU legislation must be accompanied with the reduction of equivalent burdens in related policies.

Stakeholder consultation

Since its introduction, Better Regulation has gradually expanded commitments to consult with stakeholders and citizens throughout the policy cycle. Stakeholders are invited to express their opinions and feed into policy development and evaluation, including the assessment of potential policy impacts. This is done through a range of formats such as online surveys, open statements, and targeted meetings. A new consultation tool introduced by the von der Leyen Commission, the ‘call for evidence’, combines a public consultation questionnaire and early feedback on plans for initiatives – separate consultation steps until 2021. Stakeholders can also submit comments on legislative proposals, delegated and implementing acts adopted by the Commission, before these move on to be considered by the European Parliament and Council. Although the stated aim behind broadened consultation requirements is to render EU law-making more participatory by involving affected groups, concerns have been raised that these opportunities disproportionately benefit well-resourced stakeholders, including tobacco corporations and their allies.10

Principles and regulatory oversight

Throughout its operation, the agenda commits the Commission to the application of several cross-cutting principles that inform decision-making. The legal principles of proportionality and subsidiarity, for instance, command that the EU should only do what is strictly necessary to achieve a desired outcome, and only act if this cannot be done more effectively at national or local level, respectively. Further principles were introduced in the late 2010s and early 2020s but are less well operationalised: ‘do no significant harm’ (the green oath of the European Green Deal), SDG mainstreaming, and strategic foresight.43

To improve the processes of Better Regulation, in 2015 the Regulatory Scrutiny Board (until 2015 Impact Assessment Board) was established to provide oversight and assess all IAs and major evaluations, in addition to providing cross-cutting guidance on the implementation of Better Regulation.13 The Board is set up as an ‘independent body’ within the Commission, led by a Commission Director-General and staffed with three high-level Commission officials and three external experts on a non-renewable three-year mandate.

Tobacco industry efforts to shape EU Better Regulation

In the 1980s and 1990s, a drive in many western countries to improve competitiveness through deregulation met with increasing scepticism about the tobacco industry’s role in public health policy and increasing regulatory pressure from the EU.

During this time, British American Tobacco (BAT) developed a strong interest in alternative ways of shaping EU legislation.9 Internal documents, made public as a result of litigation in the 1990s, reveal that BAT and other large corporations from regulated industries played an active role in promoting regulatory reform in the EU.9

Building on Philip Morris International (PMI)’s previous use of risk assessment to undermine smokefree laws in the US, BAT concluded that a similar, structured approach to risk assessment at the EU level. They sought to counter efforts to restrict smoking by positioning second-hand tobacco smoke above what is considered an ‘unacceptable risk’. Moreover, internal documents suggest that BAT believed that enshrining a requirement for conclusive evidence of the necessity and effectiveness of legislation could make it harder for policymakers to justify regulatory policies that protect public health.89

BAT also had a strong interest in promoting extensive stakeholder consultation requirements. Transparency had been an ongoing topic of debate in the European Commission since the 1990s. In 1996, the international law firm Covington and Burling advised BAT that they could use the desire for greater transparency to argue for the need for policymakers to consult with stakeholders (i.e., BAT) early in the policy process (see Image 1).14

Image 1. Law firm Covington and Burling’s advice to BAT14

BAT’s strategy to promote governance reforms

Core to BAT’s strategy was

  1. the recruitment of a supportive coalition of companies and associations from regulated industries, and a seemingly independent think tank, and
  2. the strategic use of malleable, ‘chameleonic ideas’ to make its proposed reforms palatable to a wide audience of policymakers, NGOs, and member states.9

BAT approached the European Policy Centre (EPC) to lobby for regulatory reform and recruit other corporations from regulated industries such as pharmaceuticals, chemicals, and petroleum. Using the EPC as a third party served to conceal BAT’s involvement in the campaign for regulatory change. At the same time, the number of organisations involved in the campaign gave the impression to EU member states that there was great and diverse pressure for regulatory reform in the EU.89

BAT collaborated with the EPC to recruit more companies and in 1996 established the EPC Risk Forum, a closed group which focused specifically on the role of risk in regulation.9  Similarly, BAT and other companies came together in 1999 to form the UK-based Fair Regulation Campaign which lobbied for regulatory reform at both the EU and UK level.8 They successfully got the UK Presidency of the EU to sanction a conference paid for by BAT (it is not clear whether attendant policy makers were aware that BAT funded the event).

BAT was so successful in obfuscating their involvement that European Commission staff had no awareness that the tobacco industry was involved in the reforms:8

“I would be absolutely astonished and would find it very difficult to believe if there was any information available which tended to indicate that the European Policy Centre was advocating on behalf of the tobacco industry – that would be shocking.” David Byrne, Commissioner for Health and Consumer Protection 1999-2004 (Interview 27 August 2008)8

Through its broad coalition, BAT promoted its desired regulatory reforms by employing what Smith and colleagues term ‘chameleonic’ ideas: malleable concepts that can be used strategically to appeal to diverse audiences. In the case of Better Regulation, BAT and its allies presented the proposed changes as minor technical tools when communicating with policymakers, and as fundamental reforms when speaking to corporate partners.9

Changes to the Treaty of Amsterdam

Working with the EPC and business lobby groups such as the Union of Industrial and Employers’ Confederations of Europe (now BusinessEurope), and the Confederation of British Industry, BAT established lobbying campaign for changes to the Treaty of Amsterdam. These changes were subsequently adopted, codifying an obligation to consult widely in all future policy proposals and to reduce the burden of policy changes on “economic operators”, i.e., businesses.8915

The precautionary principle

A major focus of BAT’s campaign for regulatory reform was the use of the precautionary principle which is a crucial factor in the EU’s approach to risk. Based on a perception that decision-making based on precaution would result in greater regulation of their products, BAT and its allies promoted an alternative approach centred around minimising business impacts of regulation and safeguarding innovation.9 Further, the so-called ‘innovation principle’ was first promoted by the European Risk Forum, an organisation that spun off in 2007 from the EPC’s Risk Forum which was dominated by corporate actors such as BAT.8 There is some evidence indicating a shift in policymakers’ perceptions of risk and precaution in line with BAT’s objectives16 and the use of the innovation principle within corporate efforts to undermine public health and environmental protections has been documented by civil society organisations.17

Possible consequences of the Better Regulation framework

While internal tobacco industry documents provide significant insights into the corporate campaign in the lead-up to Better Regulation in the EU, less information is available on tobacco industry activities after the early 2000.9 Nonetheless, there is evidence to suggest that tobacco companies and other actors from regulated industries harness Better Regulation provisions in their favour and continue to seek to shape how the EU makes decisions on regulation. In addition to cautioning against a deregulatory or chilling effect resulting from Better Regulation’s focus on regulatory burdens, civil society organisations have expressed concerns that the way in which tools such as consultation and impact assessment are operated disproportionately benefits well-resourced industry interests.181920

The European Risk Forum, renamed in 2021 to European Regulation and Innovation Forum,  continues to describe itself as an “expert-led think tank” and claims that throughout its history, it has “never been involved in lobbying for any particular product or sector ”.21 It remains active in debates on EU regulatory reform and appears to maintain high-level access, for instance, to the Regulatory Scrutiny Board.2223 The Forum lists among its self-declared achievements that it played an important role in “establishing formal requirements for cost-benefit analysis at EU-level in the Amsterdam Treaty”, “the Commission adopting its modern system of impact assessment”, “the creation […] of the Regulatory Scrutiny Board”, and increasing recognition of the innovation principle.24

During the 2014 Tobacco Products Directive revision, tobacco companies harnessed Better Regulation provision to increase their access to officials and overwhelm the consultation process.25 Despite efforts by DG SANTE to safeguard tobacco control policy from undue influence, two inquiries by the European Ombudsman have since indicated that a lack of transparency on interactions with the tobacco industry persists in large parts of the European Commission.2627

Better Regulation used to challenge tobacco control internationally

Better Regulation and related ideas have been used internationally to challenge tobacco control policies and safeguards against undue corporate influence.

Attempts to undermine Framework Convention on Tobacco Control Article 5.3

Tobacco companies and allied third parties lobbied extensively against the World Health Organization’s Framework Convention on Tobacco Control (FCTC). Recognising that tobacco industry interference presents a major obstacle to tobacco control, the FCTC included a proposal to limit tobacco company influence on health policies – Article 5.3 – which states that:

“in setting and implementing their public health policies with respect to tobacco control, Parties shall act to protect these policies from commercial and other vested interests of the tobacco industry in accordance with national law.”28

After initial efforts to prevent Article 5.3 were unsuccessful, tobacco corporations have sought to undermine its implementation in the UK and the EU by arguing that this would contravene Better Regulation principles, in particular commitments to broad stakeholder consultation. 29

In the UK, where a Better Regulation programme is also in place, BAT’s response to the 2008 public consultation on the Future of Tobacco Control argued that the draft guidelines outlined in Article 5.3 of the FCTC “could result in less than full and proper consultation with the tobacco industry. Such a proposal would be inconsistent, not only with UK Government policy but with the European Commission’s commitment to open consultation.”29

At the EU level, BusinessEurope, for instance, sent a letter to European Commission President José-Manuel Barroso in August 2008, expressing serious concern about the upcoming implementation of Article 5.3 and arguing that “proper consultation of all affected stakeholders carried out in accordance with the Commission’s general principles and minimum standards is crucial for getting an idea about the cost-effectiveness of legislation.”29

UK Plain Packaging

In their submissions to the 2012 UK public consultation on plain (standardised) packaging for tobacco products, each of the big four tobacco companies in the UK argued that policy makers and the public health community were acting in a way that contravened the principles of Better Regulation.

For more information see Plain Packaging in the UK

Relevant Links

EU Commission’s ‘Better regulation’ toolbox.

EU Commission’s ‘Better regulation’ guidelines

TobaccoTactics Resources

TCRG Research

For a comprehensive list of all TCRG publications, including research that evaluates the impact of public health policy, go to TCRG publications.

Print Friendly, PDF & Email


  1. European Commission, Better regulation for better results – an EU agenda, May 2015, accessed July 2022
  2. abcEuropean Commission, Better regulation: Joining forces to make better laws, April 2021, accessed July 2022
  3. abcdEuropean Commission, Better Regulation Guidelines, November 2021, accessed July 2022
  4. abcEuropean Commission, Better Regulation Toolbox, November 2021, accessed July 2022
  5. Corporate Europe Observatory, ‘Better Regulation’: corporate-friendly deregulation in disguise, 18 February 2020, accessed July 2022
  6. ETUC, Better regulation, accessed July 2022
  7. Smokefree Partnership, The Origin of EU Better Regulation – The Disturbing Truth, 24 February 2010, accessed March 2021
  8. abcdefghK. E. Smith et al, “Working the system”- British American Tobacco’s influence on the European Union Treaty and its implications for policy: an analysis of internal tobacco industry documents, PLoS Medicine, 2010, 7(1):e1000202, doi:10.1371/journal.pmed.1000202
  9. abcdefghijkK. E. Smith et al, Corporate Coalitions and Policy Making in the European Union: How and Why British American Tobacco Promoted “Better Regulation”, Journal of Health Policy, Politics and Law, 2015, 40(2):325-372, doi:10.1215/03616878-2882231
  10. abK. E. Smith et al, Is the increasing use of Impact Assessment likely to undermine efforts to achieve healthy public policy?, J Epidemiol Community Health, 2010, 64:478-487, doi:10.1136/jech.2009.094300
  11. EUR-Lex, Precautionary principle, Accessed July 2022
  12. European Commission, Communication on EU regulatory fitness, December 2012, accessed July 2022
  13. European Commission, Regulatory Scrutiny Board, accessed July 2022
  14. abCovington & Burling, EC risk assessment proposal, Truth Tobacco Industry Documents, 8 February 1996, ID:ftgx0195
  15. European Communities, Treaty of Amsterdam amending the Treaty on European Union, the Treaties establishing the European Communities and Certain Related Acts. Office for Official Publications of the European Communities and Europa, 2 October 1997, accessed June 2013
  16. R. E. Löfstedt, The swing of the regulatory pendulum in Europe: From precautionary principle to (regulatory) impact analysis. The Journal of Risk and Uncertainty, 2004, 28(3):237-60, doi:10.1023/B:RISK.0000026097.72268.8d
  17. Corporate Europe Observatory, The ‘innovation principle’ trap: Industries behind risky products push for backdoor to bypass EU safety rules, December 2018, accessed July 2022
  18. Corporate Europe Observatory, ‘Better Regulation’: corporate-friendly deregulation in disguise, February 2020, accessed July 2022
  19. Corporate Europe Observatory, Commission CON-sultations, May 2016, accessed July 2022
  20. New Economics Foundation, Reprotecting Europe, May 2016, accessed July 2022
  21. European Risk and Innovation Forum, A short History of the ERIF – 1991 to 2021, January 2021, accessed July 2022
  22. European Commission, Meetings of Chair of the Regulatory Scrutiny Board Anne Bucher with organisations and self-employed individuals, accessed July 2022
  23. Regulatory Scrutiny Board, reply to GESTDEM 2022/1868, April 2022, accessed July 2022
  24. European Risk and Innovation Forum, Main achievements, January 2021, accessed July 2022
  25. S. Peeters et al, The revision of the 2014 European tobacco products directive: an analysis of the tobacco industry’s attempts to ‘break the health silo’, Tobacco Control, 2016, 25:108-117, doi:10.1136/tobaccocontrol-2014-051919
  26. European Ombudsman,!FrJg8J, December 2016, accessed July 2022
  27. European Ombudsman, Letter from the European Ombudsman to the European Commission on the transparency of its interactions with representatives of the tobacco industry, March 2022, accessed July 2022
  28. World Health Organization, Framework Convention on Tobacco Control, 2003, accessed June 2013
  29. abcK. E. Smith, A. Gilmore, G. Fooks, J. Collin, H. Weishaar. Tobacco industry attempts to undermine Article 5.3 and the “good governance” trap. Tobacco Control (18), 2 December 2009, accessed March 2021.