The MEB operates in a continuously changing environment. How this environment changes is partly predictable, but also uncertain to a significant degree. The strategy that MEB uses responds to both certain and uncertain developments. The MEB is setting the course for the next two years with the annual plan for 2017 and 2018. This gives concrete details for implementing the Strategic Business Plan 2014-2018.
The Ministry of Health, Welfare and Sports has started a broad movement in order to ensure improvements in care. It is aiming for greater transparency, less regulatory pressure, information standardisation and encouragement of innovation. The MEB is already working on these themes and will follow them up over the coming years, both nationally and in a European setting.
The context and the implications are increasingly important when decisions are being taken about medicines. The MEB has referred to the way that it will be shaping this further as ‘adaptive regulation’. Adaptive regulation is a term for the approach taken by the MEB to make sure that the general interests of patients are weighted heavily, besides the scientific data. Where necessary, the MEB will use the scope provided by the regulations to make the right considerations to ensure that patients are given good and safe medicines. The MEB wants to develop the concept of ‘adaptive regulation’ further, which is why it is one of the central themes in the annual plan.
There are considerable challenges for the entire European network of pharmaceutical authorities over the coming years in making sure that innovative medicines are made available for patients quickly but responsibly, in particular when 'unmet medical needs' are involved. This requires interaction from all parties involved in the development and the use of medicines.
An important development is the possible withdrawal of the United Kingdom from the EU. Although it is unclear what the actual consequences of Brexit may be for the Netherlands and the EU network, it is important to anticipate them at an early stage. A large amount of work may have to be reapportioned between the medicines authorities of the various Member States. This requires more cooperation – and different cooperation – as well as less complexity in the regulatory system.
More work as the result of Brexit has not yet been taken into account for 2017. In its annual plan, the MEB has assumed for the time being that the number of procedures in 2017 will be comparable to that of 2016. It may well be the case that this assumption needs to be revised.
Annual plan for 2017 and 2018
The central objective of the MEB when carrying out its legal tasks is:
“Adaptive and innovative regulation, while taking the practice into account through patient-oriented assessment and promotion of the proper use of medicines”.
To achieve its central goal, the MEB has defined a number of concrete aims that apply for the coming 2 years. In other words, until the end of the term of the Strategic Business Plan 2014 - 2018:
- The MEB knows the end users (patients, healthcare providers) and integrates the knowledge and practical experience gained into its assessments and activities to encourage the proper use of medicines, for example. To that end, the MEB will be intensifying its contacts with numerous organisations. Setting up patients’ and healthcare providers’ panels is also part of the programme.
- Information from the MEB will be made easier to understand and more accessible for patients and healthcare providers, by organising the provision of information differently. To realise this, the MEB is starting initiatives to ensure digital searchability of medicine information such as patient information leaflets and more detailed product information (Summaries of Product Characteristics, SmPCs) as well as further optimisation of the MEB’s Medicines Information Bank.
- What the MEB is doing is effective. The MEB uses regulatory science and research work to improve its efficiency and effectiveness. Participation in European and scientific and regulatory initiatives is essential for innovative regulation. Another element in these aims is the satisfaction surveys among organisations that the MEB cooperates with.
- The MEB is an organisation aware of its surrounding with a clear focus and a great deal of flexibility. Adaptive regulation, a focus on its surrounding and research will be embedded yet further in the organisation. This also requires changes to the MEB processes and systems. There will be substantial investment in IT, according to a new “I-vision”. Attention is being paid to the infrastructure, information security, renewing the primary operating system and cooperation with other Member States to ensure connection to European IT systems.
- The right people are in the right places. In 2017, the MEB’s operations will pay particular attention to human resources policy. The way that new employees are recruited will be re-examined and the development of employees will be more aligned with the organisation's ambitions.
Concrete activities for 2017 have been defined in the implementation chapter of the annual plan, and measurable targets have been added. The stated aims are to be realised in a 2-year timeframe.
A number of activities have not been included explicitly in the annual plan, although they are part of the MEB’s regular work. This includes a number of activities that were prominent in 2016, such as the MEB and the Health Care Inspectorate setting up the Medicine shortages and defects notification centre, and the approach to antibiotic resistance.
In the annual plan, the MEB is also outlining the strategy of the Strategic Business Plan for 2014–2018. The strategy looks at the entire lifecycle of medicines even more strongly than before, from early development through to their use in practice. Here, the MEB puts patient's interests first. The MEB cooperates actively with its surroundings, including both patients and health care professionals. In addition, the MEB is continuously working on strengthening national, European and worldwide cooperation between pharmaceutical authorities and the parties in the care chain.
The three main themes of the Strategic Business Plan are woven into the annual plan:
Patient-oriented evaluation of medicinal products
Promotion of proper use of medicinal products
Promotion of innovation of medicinal products