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Gerry Stimson | 21 September 2013

New report by Clive Bates and Gerry Stimson on the Costs and burdens of medicines regulation for e-cigarettes.
What were the MHRA, the Department of Health, and their health advisers thinking when they embarked on the e-cigarettes as medicines route? The more you analyse it, the more medicines regulation appears to lead to a monstrous perversion of public health objectives.

E-cigarettes are the big consumer led public health revolution. E-cigarettes have been widely adopted despite neglect – and indeed antipathy – from public health leaders. The government mindset should be to do everything to build on and enhance this. Enter the regulators and their advisors, who think they can do better than the hundreds of thousands of e-cigarette users who already know that e-cigarettes are a good thing for them.

The Only Way Is Medicines (TOWIM) position is that ‘we can make the product better’. Lacking knowledge of consumer choices (individuals showing preferences for lower risk products, choosing their best products from the range available), and lacking knowledge of product development and marketing (companies competing to deliver better products) TOWIM proponents think that a regulatory fix is the only way to improve the product.

There are hundreds of products on the market in thousands of variations. There is a vibrant industry of perhaps 300 successful and emerging small and medium enterprises (SMEs) all over the UK either making and marketing products, or importing and reselling from manufacturers in the Far East. Larger players, including tobacco industry subsidiaries, are becoming involved and will bring technology, marketing and distribution reach. Poor products on the market are being superseded by superior products through the normal processes of consumer choice and supplier innovation interacting in a competitive market.

Risk averse regulators and their advisors claim these products are ‘unregulated’. To the contrary, there are already 17 European directives and regulations that manage general safety, electrical safety, packaging and labelling, quality and fair commercial practices in this market (see http://www.clivebates.com/?p=1092) . They are not ‘unregulated’, and a voluntary industry code has raised standards and assisted trading standards officers in targeting poor quality producers (see http://www.ecita.org.uk/theise.html)

So – is there a problem in need of fixing?

Medicines regulation – far from improving the product and extending the reach of products to new consumers - will have the perverse effect of turning back a consumer led revolution that has been developing quite happily without benefit of medicines regulation. The main threat to this active and highly beneficial market is excessive and poorly conceived legislation.

Clive Bates and I have conducted a detailed analysis of the potential impact of medicines regulations in our report on the Costs and burdens of medicines regulation for e-cigarettes.

We conclude that there are no problems that justify a further dramatic regulatory intervention, and the rationale for intervening in this way is weak and unconvincing.

To repeat – there is not a problem in need of fixing.

We identify major issues in applying medicines regulation to e-cigarettes including:

  • Burdensome application process and information requirements
  • Disproportionate costs of achieving Good Manufacturing Practice
  • Excessive costs and burdens of the medicines quality management regime
  • Unclear purpose of tests required for a license application
  • Severe impact of licensing restrictions on the range of products available
  • Dampening effect on innovation and creativity
  • Unwarranted forced restructuring of the market and industry
  • Counterproductive social cost of reduced quitting and extra harm
  • Negative implications for specialist high street retailers
  • Excessive and counter-productive restrictions on marketing
  • Discriminatory and unnecessary risk management and surveillance obligations
  • Unintended consequences – home production, internet sales and black market

This process has exhibited poor regulatory practice including:

  • Inadequate impact assessment
  • Inadequate consultation
  • Overlooking e-cigarette industry efforts to manage risk
  • Narrow sources of advice – advisors on the Commission on Human Medicines.

We conclude that medicines regulation for e-cigarettes will:

  • Destroy the existing supply chain and most businesses
  • Create a de facto ban on most products
  • Make e-cigarettes harder to buy than tobacco cigarettes
  • Favour the cigarette industry
  • Induce significant legal risk
  • Create high and unnecessary barriers to entry for firms and products.

In short, medicines regulation focuses on creating a better medicinal product, whereas the public health is served by having better alternatives to cigarettes.

The government should revisit the policy of treating e-cigarettes as medicines.

The government should:

  • Immediately reserve its position on e-cigarettes (Article 18) in the context of the Council deliberations on the Tobacco Products Directive. The UK government should do this until it has properly assessed the impacts and ministers are clearly sighted on the consequences for the businesses and users involved and the potential damage to public health
  • Initiate a ‘Red Tape Challenge’ process on the application of medicines regulation to e-cigarettes under the ‘challenger business’ theme of the Red Tape Challenge.
  • Prepare an updated Impact Assessment that addresses the deficiencies raised in this report and properly assesses the impacts on the existing e-cigarette industry.
  • Invite the Regulatory Policy Committee to examine the current proposals, the impact assessment and process followed and to provide advice to ministers.

The Department of Health, with support from the Department for Business, Innovation and Skills should:

  • Urgently examine non-medicines options for proportionate regulation that meets the government’s better regulation and red tape objectives. The MHRA is bound to medicines regulation and cannot therefore do this.

The E-cigarette industry should:

  • Commit to strengthening and formalising its own code, the Industry Standard of Excellence, and to do more to assist trading standards officers in applying risk-based regulation.

See the full report on the Costs and burdens of medicines regulation for e-cigarettes.