Policy development and delivery

Regulatory systems and legislation for medicines and medical devices are increasingly derived from European Directives. The Agency is committed to ensuring that UK, and the interests of UK citizens and industry, have a strong, proactive and leading voice in the development and implementation of European legislation.

All our policy initiatives are undertaken with the principles of Better Regulation in mind, so that the regulatory framework is proportionate, targeted, and focused on activities that can make a real difference to safeguarding health and for the benefit of patients.

Policy development
Agency policy initiatives can arise from various sources, for example:

• Negotiations in Europe
• Implementation into UK law of European legislation
• National regulatory or procedural initiatives
• Suggestions from stakeholders
• Internal or external sources of evidence that changes to existing policy or practice are needed.

In all these cases it is important that there is evidence that the proposed policy and the way in which it is delivered must improve or maintain public health, and is as proportionate, transparent and risk based as possible.

To ensure this we carry out extensive consultation with stakeholders as a key part of the policy development process. Consultation can provide answers to critical questions raised by the policy proposal, and ensure that stakeholders are actively engaged with and can properly influence the policy making process. Current and past Agency consultations can be found in our Consultations section. The Agency follows the Government Code of Practice on Consultation (external link) which sets out six criteria which must be followed in all consultation exercises. In addition to formal consultation processes, we aim to engage and work with interested stakeholders to ensure that they have every opportunity to comment on and influence the Agency’s decisions.

Robust evidence gathering is essential if we are to be aware of the impact of our proposals on stakeholders. As part of the policy development and consultation process the Agency publishes Impact Assessments (IAs) of its proposals. An IA helps us to focus on the purpose and impact – both financial and non-financial – of the policy, including consideration of a ‘do nothing’ option.

Policy delivery
After the consultation the Agency implements the policy, taking into account the views and suggestions of stakeholders as far as is possible. For major policy proposals, and for all regulatory changes, Ministerial agreement must be obtained Implementation can take a variety of forms: regulation, changes to procedures or new or revised guidance for industry. In all cases we ensure that affected stakeholders have good notice of the changes so they are able to prepare for change and where necessary update their own procedures. Parliamentary business must also be effectively discharged.

It is important that the real effect of policy on public health and on stakeholders is measured and the success of the policy reviewed. We need to know if our actions achieved the outcomes that we wanted and expected. The Agency therefore carries out post-implementation reviews of new policies. This gives us a chance to revise them if necessary.

Engagement in Europe
The Agency aims to be one of the leading authorities in Europe, not only in scientific and operational work, but also in influencing the policy and legislation that underpin much of what we do. Teams in the Policy Division coordinate the Agency’s input, on behalf of UK Government, to all negotiations in Brussels on medicines and medical devices legislation.

But we see our role in Europe as wider than just formal negotiations on new legislation; for example we work closely with fellow regulators from other EU countries, through the Heads of Medicines Agencies, and the network of Competent Authorities for Medical Devices, exchanging best practice and working together on matters of common interest. We play a leading role in the developing Heads of Medicines Agencies Benchmarking of European Medicines Agencies initiative. And we have been active in identifying “twinning” opportunities with other national regulators, helping newer Member States to develop their capabilities through a programme of training and support. All these activities enable us to deepen our links and influence across Europe, so we can shape the regulatory agenda in line with the interests of UK stakeholders and government.

Engagement beyond Europe
The Agency has links with other key regulators such as the FDA in the US and plays a leading role in international standard setting fora such as the International Conference on Harmonisation (ICH) and the Global Harmonisation Task Force on medicines and devices respectively. .We also cooperate with strategically important countries such as China which are home to an increasing amount of manufacturing and development of medicinal products.

Better Regulation
The Agency is committed to the UK government’s Better Regulation programme. Better regulation is important for the Agency as it emphasises using risk awareness to target and focus our resources and efforts on detailed consideration of the costs and benefits, both financial and non-financial, of our regulatory actions.

We are determined never to lose sight of our primary objective, the protection of public health, but we recognise that reducing unnecessary regulation can allow us to concentrate resources on those activities that have the greatest impact on public health. The Agency has contributed significantly to the Department of Health Administrative Burden Reduction Simplification Plan (external link), and is taking a lead role in shaping the developing European better regulation agenda.

The Hampton principles
The government has issued a statutory code of practice The Regulators’ Compliance Code (external link). This Code places a duty on regulators to carry out their responsibilities in a proportionate, risk aware and transparent way. The Agency seeks to develop and deliver policies in compliance with the Code, and with the Hampton principles (external link) from which the Code derives. These principles can be summarised as:

• Comprehensive risk assessment should be used to concentrate resources on the areas that need them most
• Regulators should be accountable for the effectiveness of policies and the decisions they take
• Inspections should not take place without a reason
• Businesses should not have to give unnecessary or duplicate information
• Businesses that persistently break regulations should be identified quickly
• Regulators should provide authoritative and accessible advice easily and cheaply
• Regulators should recognise that a key element of their role is to allow economic progress and only intervene when there is a clear case for doing so.