EPHA’s opinion on Smart Regulation

The Smart Regulation Agenda is the follow-up to the ’Better Regulation Agenda’ which aimed to simplify legislations and reduce administrative burdens; better implement Impact Assessments; and reinforce stakeholder dialogues.

 EPHA response to the Smart Regulation consultation

General Comments

EPHA considers that the current approach to improving legislation put too much emphasis on conditions to improve competitiveness in economic sectors without due attention to the public interest, including health and well-being.

We also consider that the current Better Regulation agenda has been mainly accountable to economic operators, rather than to citizens themselves.

Smart Regulation - EPHA recommendations

EPHA argues that several ways to be use to shift the Smart Regulation Agenda:

Establish the well-being of people as the overarching objective of the Smart Regulation Agenda The primary objective of the future Smart Regulation Agenda should be enshrined into the Treaty of the European Union, namely to achieve the aim of the European Union as stated in Article 3.1 of the consolidated Treaty of the European Union: “the Union’s aim is to promote peace, its values and the well-being of its peoples”.

Go beyond GDP to regulate smartly EPHA therefore recommends that the European Commission speeds up the development of multiple indicators to measure progress and development that go beyond the narrow measure of GDP.

Include improving the health status of the population as one of the sub-objectives of the Smart Regulation Agenda

Regulating smartly still means regulating, not self-regulation EPHA would also like to point out that simplifying legislation should not lead to lowering the standards laid down in current or past legislations, especially when it relates to protecting the health of people.

We therefore urge the European Commission to strongly reconsider the use of self-regulatory instruments when regulating on legislation impacting on health: the health of the population should always prevail on businesses’ interests, in order to meet the commitments enshrined in the Treaty.

Repeal the 25% reduction of administration burden target as a stand alone target EPHA considers that the target of 25% reduction of administrative burden puts undue pressure on reducing administrative burden at the expenses of considering other objectives which may require an increase of administrative burden in the short term to be effective in the longer run.

Restructure the High Level Group for Reducing Administrative Burden Given that creating business and market conditions that lead to health, environmental and social well-being of people should be the primary objective of the Smart Regulation Agenda, this should be reflected in the composition of the High Level Group for Reducing Administrative Burden.

Include the third sector and public administrations as a target to administration reduction programmes

Balance simplification with benefits and costs for long-term public goals

It would be useful if the Commission could in the future clearly spell out why such a simplification is beneficial and for whom. In those cases in which simplification benefits are likely to be significant for business in the short term but have a negative impact on society in the long term, the potential cost savings should be assessed quantitatively and qualitatively taking into account both the long term and short term time frame.

EPHA suggestions on Impact Assessments

EPHA considers Impact Assessments as an important tool to help take decisions. However, we would like to remind decision makers that Impact Assessments should not replace the decision-making itself. The final decision, in particular trade-offs should remain in the political domain. Impact Assessments add to the length of a process and are often use as an excuse not to regulate. They shouldn’t be used to delay further regulations.

Implement Sustainability Impact Assessments EPHA disagrees with the side by side assessment of all relevant impacts as we believe this has not provided for an integral approach. EPHA would therefore call on the European Commission to promote an integrated approach to Impact Assessment through ‘Sustainability Impact Assessment’. Sustainability Impact Assessment would focus on environmental, social, health and equality objectives and would also assess the costs of action and inaction.

Health should be integrated in the Sustainability Impact Assessment system.

Consider qualitative as well as quantitative impacts The overwhelming importance of economic impacts means that other impacts had to be quantified and monetised. This triggers a question: How much is a life worth? Balancing the interest of competition with health outcomes means monetising the price of a life, which is clearly unethical and doesn’t help the EU moving towards improving the well-being of its people.

External Impact Assessments should be closely monitored and tendered to avoid conflict of interests arising.

EPHA suggestions on stakeholders involvement

Revise the minimum standards for consultation and improve the timing for consultations to twelve weeks

Stakeholder engagement through High Level Groups, Expert Groups, etc need a drastic revision.

For more information

 EC Better Regulation website
 Event:EU Better Regulation : from economic to citizen-centric ?
 EPHA briefing note on Regulation, Self-regulation and Co-regulation
 Tobacco industry leads industry lobby attempt to skew policy-making : new evidence