Better Regulation still needs to convince Health stakeholders

Health community representatives seem far from convinced by the EC's Better Regulation policy, if those who spoke at the EPHA conference last week are to be believed.

Ms Christina Colclough, from UNI Europa (trade union for private employees) told how "disappointed" her organisation was with BR for not tackling the main challenges to Europe, including that of raising social standards.

Ms Magda Stoczkiewicz, director of Friends of the Earth, regretted that an excessive focus on administrative burdens, instead of the benefits of legislation, which made the EC's agenda look like a Business Europe position.

Ms Florence Berteletti, director of Smokefree Partnership, reminded the audience that industry lobbies were behind the adoption of RIA, a thesis researched by Dr Katherine Smith, in a report launched in the European Parliament in 2010 (see blog post).

On the other hand DG Santé representative and your blogger were given the time to defend a more positive reading of the recent Commission BR package, and Ms Tamsin Rose (Friends of Europe think-tank), pointed out that BR should reduce the irrationality of policy-making. 

Moderator Nina Renshaw, secretary general of EPHA, was able to wrap-up with some forward-looking conclusions:

- BR and RIA were an opportunity that the Health stakeholders should embrace and make heard the voice of their communities in the policy-making process at EU level. 

- the cost of doing nothing option should always be assessed (such as the cost of doing nothing to provide health care to migrants)

- BR should be used to increase the accountability of politicians when pursuing policies not supported by evidence.

See also post on calling the conference (below).

Better Regulation to support better health

Better Regulation has always found in Health issues a rich terrain to test the effectiveness of the solutions it offers the economy and society. See the 23 posts of this blog under the Health category.

Our community will have a new opportunity to identify current trends and update our principles and tools, at the Annual conference of the European Public Health Alliance (EPHA), "Europe's leading NGO advocating for better health," to be held in Brussels on 2-3 September 2015.

The theme of the conference "Towards a European Union for Health - From Health in All Policies to EU Governance for Health and Well-Being?" will give rise to a number of panels and discussions, including one entitled: "Better Regulation for Better Health? Mainstreaming public health into the EU's agenda." The conumdrum is defined as: "Better Regulation is now an even greater priority for the European Commission through the REFIT process. Where does this leave broader issues of labour rights, health and safety, environmental protection or public goods that are perceived as sources of administrative burdens? "

Your blogger has been invited to speak, presumably to explain the benefits of BR to a panel and audience probably impatient with simplification and burden reduction efforts (judging by the wording of the issue). 

Also follow Alberto Alemanno, the great risk and regulation expert, who will fly our colours in the session on "Europe and Chronic Diseases : challenges accepted, lessons learned, ways forward"

Stay tuned for the outcome by visiting http://goo.gl/Ec51QS @EPHA_EU

Training course on "new comitology"

(Announcement) "How the EU Impact Assessment is changing advocacy: focus on 'New Comitology' (16-17 May)": as impact assessments are increasingly being performed by the Commission on delegated and implementing acts, new opportunities for substantive lobbying emerge. This one-day training will offer a unique opportunity to understand how your organisation may ask the Commission to run an Impact Assessment and also how to use it in the decision-making process. Our case studies will be based on the most recent and controversial risk regulatory decisions such as Bisphenol A and Neonicotinoids.
With a guest speaker from the European Parliament's newly created Impact Assessment unit, and former EU Commission officials and Court of Justice of the EU you will get a unique insight to the latest developments and get practical tips on how to work with IA in regulatory affairs.
To see the detailed programme, click here: http://www.eu-academy.eu/training/impact-assessment-comitology-stakeholders-and-advocacy/

Smarter rules for safer food (Commission)

The European Commission adopted on 6 May a package of measures to strengthen the enforcement of health and safety standards for the whole agri-food chain. Smart regulators will be interested in the claim that the proposals have been inspired by the principles of better or smart regulation, more than in the relation with the horsemeat scandal which is undoubtedly in the back of the minds of the Commision:
According to the press release, "the package of measures provide a modernised and simplified, more risked-based approach to the protection of health and more efficient control tools to ensure the effective application of the rules guiding the operation of the food chain. The package responds to the call for better simplification of legislation and smarter regulation thus reducing administrative burden for operators and simplifying the regulatory environment. Special consideration is given to the impact of this legislation on SMEs and micro enterprises which are exempted from the most costly and burdensome elements in the legislation. The current body of EU legislation covering the food chain consists of almost 70 pieces of legislation. Today's package of reform will cut this down to 5 pieces of legislation and will also reduce the red-tape on processes and procedures for farmers, breeders and food business operators (producers, processors and distributors) to make it easier for them to carry out their profession." Yes, the elements are there: simplification, risk-based approach, reduction of aministrative burde:s, impact assessment, SMEs test, consolidation. For more on the package, see press pack.

New figures concerning US regulatory costs

An interesting but highly critical study of the recent evolution of regulatory reform was published on 17 January by Free Enterprise. It quotes a study by the the American Action Forum showing that "$518 billion in new regulatory costs have been dropped on the economy in the last four years, nearly $216 billion in 2012 alone. Three big culprits are EPA, the Dodd-Frank financial reform law, and the health care law, and in 2013, expect more costly rules from each of them." The article also gives the example of mandated menu labeling (includig calorie count) for chain restaurants and "similar retail food establishments," including pizza franchises and grocery stores, that will cost $757 million, with figures taken from the Federal Registry RIA (enough to cut your appetite).

Risk and Smart Regulation (EJRR)

The assessment and mitigation of risk is one of the more complex issues faced by smart regulators. Most regulators have devised strategies and developed tools to cope with this dimension: see for instance "Risk and Regulatory Policy: Improving the Governance of Risk" by OECD. The latest issue of the European Journal of Risk Regulation hosts inter alia a special symposium devoted to the operation of the Parliament’s own Science Unit: the Science and Technology Options Assessment (STOA). One of the articles addresses "The changing face of risk governance: Moving from precaution to smarter regulation” (by subscription or purchase.)
The EU definition of the precautionary principle in public decision making is given in another article: it concerns situations "where following an assessment of the available scientific information, there are reasonable grounds for concern for the possibility of adverse effects on the environment or human health, but scientific uncertainty persists. In such cases provisional risk management measures may be adopted, without having to wait until the reality and seriousness of those adverse effects become fully apparent."

Food law enforcement under public scrutiny (UK)

On 1 May, the Department of Business, Innovation and Skills (BIS) launched the first review theme for the Government’s Focus on Enforcement campaign (see previous post), which will concern food manufacturing companies. This initiative is important for us experts as it provides a practical illustration that Better Regulation policies must include steps to determine how enforcement of regulation can be improved, reduced or done differently.

To provide facts for the future review of regulation, For the next five weeks, small businesses in food manufacturing are invited to share their experiences of working with national regulators and local authorities. This can include:

• Dealing with paperwork.
• Inspections.
• Advice given by regulators on how to comply.

APEC links RR with trade and green growth

There is a lot of conceptual material to be found in the proceedings of the 2011 APEC ministerial meeting held in Honolulu, Hawai, on 11 November and chaired by Ms Clinton. In a “Declaration of Honolulu – towards closer regional economic ties,” APEC Ministers committed to take action to strengthen economic integration and expand trade, promote green growth and advance regulatory convergence and cooperation, to achieve economic growth in the region. The statement published on the APEC site and the annex F on regulatory issues provide rich reading. Here are the main chapters (our unofficial summary):

• "Regulatory Cooperation on Emerging Standards and Regulatory Issues for green growth": the objective is to prevent unnecessary technical barriers to trade, support interoperable emerging standards for smart grids, green buildings, and solar technologies.
• Approval of a "Regulatory Cooperation Action Plan" to inter alia improve the efficiency and effectiveness of regulations, build public trust in regulations, improve consumer confidence in globally traded products and encourage implementation of the APEC-OECD Integrated Checklist on Regulatory Reform;
• Regulatory Convergence: streamlining approval procedures for Medical Products , harmonised classification of Chemicals, cataloguing regulations on Services, reducing unnecessary testing and streamlining paperwork on Wine certification and trade procedures, raising common Food Safety rules, including closer alignment on international standards (with APEC-World Bank collaboration).

In summary, a fine example of effective regional regulatory cooperation.

New definition of smart regulation (US FDA)

Under the title " FDA official urges smart regulation" a short article in the Philadelphia Inquirer online edition uses smart regulation to sum up a necessary new paradigm for Health law. "Caught between wary patients who want safe artificial hips and demanding medical-device manufacturers who want their potentially lucrative gizmos approved yesterday, the top device official at the U.S. Food and Drug Administration told skeptical industry executives gathered Monday at the Convention Center that he was trying to institute a paradigm shift to help all parties.
'It's not safety or innovation, Dr. Jeffrey Shuren said. It's safety and innovation.
'We needed to move away from this construct that safety and effectiveness and facilitating innovation are incompatible," Shuren, director of the FDA's Center for Devices and Radiological Health, said at the Biotech 2011 conference, "They are both sides of our mission."

Commission proposes electronic ID for bovines

One of the most potent administrative burden reduction measures at EU level, which had been under study for two years, has been given a green light. On August 31, the European Commission adopted a proposal that will, it claims, further enhance food safety and better safeguard animal health in the EU when it is implemented. 

From the press release: "In particular, the Commission proposal provides the legal framework for the introduction, for the first time and on a voluntary basis, of an electronic identification system (EID) for bovine animals. Bovine EID is already used in several EU Member States on a private basis mainly for farm management purposes. Its implementation on a wider scale will strengthen the current traceability system for bovine animals and food products (e.g. beef) making it faster and more accurate. Finally, it may bring benefits to farmers and other stakeholders as it will reduce the administrative burden through the simplification of the current administrative procedures. Despite its voluntary character, the Commission proposal allows Member States to introduce a mandatory regime at national level.In addition to EID, the Commission proposal introduces changes in relation to labelling, by repealing the current provisions on voluntary beef labelling. The main objective is to reduce unnecessary administrative burden."

This measure had been one of the key suggestions stemming from the "baseline operation" within the Action Programme for reducing administrative burdens in the European Union ("Food Safety" priority area).

Why"green tape" is good for business

At last year's OECD conference, one of the ideas new to some of participants was that environmental protection should not be viewed only a source of administrative costs, it actually boosted economic performance. This is confirmed by recent research: a new working paper from the National Bureau of Economic Research found that reducing ground-level ozone (a main component of smog) significantly improved worker productivity.

Australian insights and recent developments in BR

According to news reports (such as ABC), an independent regulator for Australia's not-for-profit sector will be set up in the budget to be presented this week, with the aim of cutting the red tape that burdens the sector. As in other countries, the sector is seen by many as burdened by rules at state and federal levels that require them to write numerous reports for different government departments.
Reflection and lobbying are quite intense in Australia on BR issues, and can yield some good insights, owing to the traditional Australian tendency not to mince words and speak in plain English.
An example is provided by blog Safety at work that presents the current dilemma between “due diligence” and “red tape” faced by the Australian Government and its OHS regulator, Safe Work Australia. "How is compliance (due diligence) to be proven without a subsequent increase in paperwork (red tape)? In New South Wales this question is far more than a simple academic exercise on administrative process, it is a real political challenge that, if not handled carefully, could result in outrage from many business and community sectors with very little upside" asks the blog. Apparently the agency that is coordinating the changes has yet to provide detailed guidance on what is expected from “due diligence” obligation imposed on businesses but observers fear new information obligations in the form of safety audits and subsequent paperwork. The New South Wales WorkCover Authority that implements that legislation has been listed number three on the NSW Business Chamber’s list of “top 5 red tape offenders”(?), released on 9 March 2011 .





Regulation inside Government is also addressed in detail in Australia with a recent report by the Management Advisory Committee (MAC) report on Reducing Red Tape in the Australian Public Service which highlights the need for a change in thinking and approach across the public sector in order to achieve a sustained reduction in internal red tape. The report sets out a framework (to review administrative requuirements) to assist agencies in dealing with their "risk aversion" and a number of self-serving myths which the report identifies.


Meanwhile the Federal Government is not remain inactive: today it announced measures to assist SMEs in coping with red tape: The advice telephone line would be continued under new Budget funding, and a resources kit would be made available. The kit, on a USB flashdrive, lists the most common problem areas for small entrepreneurs. It would help them find government grants and assistance; be a guide for operators looking for finance and credit comparisons; and offer planning templates prepared with prominent business and financial advisors. Senator Sherry said there also would be templates for marketing and succession plans; simplified contracts for independent contractors plus a guide to such matters as tax and super measures.

Announcement of Conference on REACH - 22/2/2011, Brussels

This blog has been informed of a Conference on REACH - Challenges after the registration deadline of 1 December 2010 - 22 February 2011,  in Brussels
 It's about the challenges after the first of three registration deadlines of the REACH regulation which has just passed: Substances in high quantities and CMR substances had to be registered by 1 December 2010.
At this conference, the second in the field of law which is covered by our European Journal of Risk Regulation (EJRR), we will evaluate and discuss the impacts and challenges of this registration deadline for the chemical industry. At the beginning of the conference the actual situation after December will closely looked at 1 from different points of view with seven speakers from various backgrounds informing the audience about their experiences. Towards the end the speakers will concentrate on a possible revision (panel discussion with all speakers).
More information and registration at bock@lexxion.de

France reviews precautionary principle

France is probably one of the only countries to have written the precautionary principle into its Constitution, in 2005. The need to forestall any re-occurence of the "scandal of the contaminated blood" was one of the driving forces behind the reform. Attention has recently been drawn back to the issue by the excessive precautions taken against the swine flu that did not materialise, and again yesterday 21 June by the publication of a report on the past hasardous effects of an insecticide in the Antilles. Earlier this month, Parliament held a seminar bringing together lawyers, philosophers, academics and others to publicise and discuss the results of a parliamentary review of the implementation of this principle. Today, Parliament examined the report.
The 2005 constitutional amendment introduced a Chart of the Environment defining conditions (grave danger, uncertain scientific evidence) in which specific risk assessment procedures and conservatory measures should be used. The drafters of the review have noticed that the principle was being applied to a wider range of issues than initially foressen (on this see previous post on this blog) and call for a new text to further specify the conditions, stressing proportionality and insisting that precautionary measures should always be temporary. Good dossier on Vie-Publique.fr (in French.)

European Parliament votes for simpler food labelling

On 16 June, the EP voted in plenary on a 2008 Commission proposal for new legislation on providing food information to consumers. The proposal combines existing rules on food labelling and nutritional information into one regulation. The aim is to make food labels clearer and more relevant to consumers, without introducing excessive labelling costs for the packaging industry. The regulation includes specific requirements for displaying information on the front of packaging. A significant part of the discussion centrered around "traffic-light" labelling supposed to provide dietary information. It seems that the some balance has been struck, in the new legislation, between the need to inform consumers, without imposing unnecessary and often illegible labels on food packages, a permanent challenge for quality regulation. Some countries, such as the Netherlands, do not consider third party labelling as administrative burdens. For background information, see Euractiv dossier.

Impending simplification of GMO authorization

As announced in March, the Commission is working on a review of its approval system for genetically modified (GM) crops. With most Europeans showing no appetite for GM produce in food, EU politicians have approved just two varieties for growing in 12 years, compared to more than 150 worldwide. Following an in-depth evaluation of GMO policy, proposals due to be adopted on 13 July, will give the European Commission greater freedom to approve new GM varieties for cultivation, in return for letting EU governments decide whether or not to grow them. According to the press release shows that EU policy is to be based on scientific assessment of health risks and sustainable innovation, and challenging the "instinctive fear and suspicion (that had) taken hold among European consumers due to scaremongering and a reluctance of industry to explain the science behind their products" (J. Dalli). This "regulatory risk" approach to EU law is consistent with President Barroso's new political guidelines. Good background on Euractiv dossier.

BR approach to bio-waste (Commission)

In a press release circulated yesterday, the Commission promotes, for a specific area of EU law, better implementation of existing texts, rather than adding new rules to the corpus. Speaking about the management of bio waste, Environment Commissioner Janez Potočnik said:   "We already have a significant body of legislation governing bio-waste in the EU. But through better implemention and enforcement, we can squeeze even more benefit from bio-waste."

See also Euractiv comment.

New research into impact assessment (health risk legislation).

Following the 24 February conference organised by Smokefree Partnership concerning the evolution of Better Regulation and risk assessment in the EU, Dr Katherine Smith (U. of Bath) has informed this blog of the publication of an article concerning impact assessment in the EU, entitled 'Is the increasing policy use of Impact Assessment in Europe likely to undermine efforts to achieve healthy public policy?'

Proceeds of Feb. conference on EU Better Regulation

Smokefree Partnership inform this blog that they have published the report of the 24 February conference, on "EU Better Regulation - from economic to citizen-centric? " which may be of interest to BR experts.

Clinical trial directive under fire

In addition to yesterday's post on recent SANCO BR activity, another of the major pieces of EU legislation on pharmaceuticals is in the line of fire: the clinical trials directive, described as "arguably the most criticised piece of legislation" the EU has ever produced on medicines", and other unflattering comments. This legal act was listed among those in scope of the Commission's Action Programme for reducing administrative burdens, but no proposal for simplification has yet been put forward. This may be about to change. See clinical trial page on Europa for reference to consultation results and roadmap of reform, and excellent Euractiv dossier of today.