IHS Global Insight Perspective | |
Significance | The European Medicines Agency (EMA) has published its strategy document for 2011–15, which includes as one of its main strategic priorities the need to resolve the gaps in drug development, particularly in the case of rare diseases and unmet medical needs. |
Implications | The EMA is looking at what it can do as the main co-ordinating agency of drug regulation in the European Union (EU) to facilitate the completion of more drug-development programmes, making regulation more "friendly" to companies dedicating resources to developing new drugs. |
Outlook | With "improved" incentives planned for companies developing new medicines in areas of identified priority, there could be some potentially very positive points of the EMA's strategy from the point of view of the pharmaceutical industry; meanwhile, the increasing complexity and geographic scope of the EMA's role in an expanding EU make its task of aligning regulation across the bloc appear increasingly onerous. |
The European Medicines Agency (EMA), the agency of the European Union (EU) with wide-ranging responsibilities in the regulation of the market for human and veterinary medicines, has published its so-called "Road Map" document for 2011–15, in which it sets out its strategic vision for development during this period. The document contains the priorities that will guide the EMA's activities during this period, as well as presenting a number of proposed initiatives aimed at realising these priorities.
As well as focusing on its core activities of the evaluation and supervision of human and veterinary medicines, and increasing its efficiency in carrying out these activities, the agency outlines in the strategy document a number of key areas of involvement during 2011–15, of which the most significant to the pharmaceutical industry are described below. The full strategy document, in English, can be accessed here.
Dealing with Gaps in Development of Medicines
The EMA highlights the absence of medicines on the market to meet certain medical needs, emphasising particularly the lack of novel antibiotics for human use, as well as rare and neglected diseases. It proposes that research should be focused on known substances to identify better methods of administration, as well as on new substances. Importantly for pharmaceutical companies, it also proposes the launching of a process of investigation and analysis into the reasons why many companies discontinue the development of medicines for human use, identifying orphan medicines as the first area to be looked at in this context. Such investigations will be followed up with proposals for actions to remedy the situation in which such a significant number of drug-development projects are stopped. The agency proposes that changes in the regulatory procedures surrounding the approval process for medicines catering for unmet medical needs, rare diseases, and neglected diseases could be made, so that the administrative burden could be eased and the process speeded up, which could have positive benefits for health in the EU and beyond.
Additionally, the agency proposes that there should be improved incentives to boost the development of medicines, with a list to be drawn up identifying the priority unmet medical needs, which would be carried out with public consultation.
Increasing Communication During Drug Development
In the context of the need to increase the number of successful marketing authorisation applications in order to facilitate the launching of a greater number of medicines aimed at more unmet medical needs, the EMA proposes that there should be a greater emphasis on drug producers who are applying for marketing authorisation applications providing regulators with more substantial information on their products and their development at earlier stages. This would remain voluntary, it emphasises, although it sets out a potential structure for more intensive interaction between applicants and regulators. Meanwhile, it is also suggested that in the interests of the "greater good", information on failed drug-development projects should be made more openly available to the public, with a view to the useful data this could make available to other producers. To this end, the EMA suggests that it will discuss with the pharmaceutical industry the potential incentives that could be offered in order to make this otherwise lost information available.
EMA Plans to Improve Role As Information Provider for Drug Regulators
In order to streamline the process of drug regulation at a time when health technology assessment (HTA) is growing in importance across the EU as governments seek to limit their pharmaceutical expenditures, the EMA proposes two initiatives. First, it plans to improve its information provision, pointing to the fact that HTA organisations across the EU are reliant on the European Public Assessment Reports (EPARs) produced by the EMA for the drugs it recommends for marketing approval in the EU. Thus, it will raise its transparency in terms of the outcome of the scientific-process section of EPARs, giving more explanation for the reasons behind decisions. It will also strive to make sure that the product-lifecycle concept is more adequately included in EPARs, in order for these documents to fulfil their intended role as a "living" document, providing up-to-the-minute information on all aspects of the product that are of interest to national regulators.
Additionally, the EMA plans to become involved with HTA agencies at the earlier stages of a medicine's development, so that it can avoid a bifurcation of the medicine-development programme, and to remain engaged with individual HTA agencies throughout the process of a new medicine's development, attempting to ensure that the evidence requirements of the HTA agencies are aligned. In general, the EMA stresses the importance of maintaining dialogue with HTA agencies throughout the lifecycle of medicinal products, in order to align more fully the collection of data obtained through post-authorisation collection.
Outlook and Implications
As the scope and range of the EMA's activities increases, and the complexity and scale of its operations grow, its importance to the pharmaceutical industry in its position as the main co-ordinator of the regulation of pharmaceutical products in the EU also grows. The strategic plan for 2011–15 contains some potentially very positive provisions for the pharmaceutical industry, in particular the possibility of improved incentives for pharmaceutical companies dedicating resources to the development of new medicines. Although the exact nature of these incentives is not discussed, there is an emphasis within the strategy paper on consultation with the industry, and working together to achieve the goal of improving health, which is likely to translate into some innovation-friendly policies—to complement the existing Innovative Medicines Initiative—in the foreseeable future.
In terms of regulation and co-ordination of the pharmaceutical industry across the EU, this task is only going to become more difficult for the EMA in the coming years, as the EU is set to expand again, with the probable entry of Croatia in 2012, and the possible entry of Former Yugoslav Republic (FYR) Macedonia at around the same time. Transposing the EMA's priorities onto these markets will require even greater effort and manpower.
Meanwhile, it remains to be seen to what extent the EMA will be able to exert a more effective centralised control of HTA agencies and bodies in EU member states than it does presently. In the context of the economic difficulties being experience by a number of countries in the EU, the use of HTA in order to restrict the entry of innovative drugs onto their markets is becoming more of an issue. Whether the EMA will be able to ensure a greater level of unity between the approach of HTA bodies in EU countries in light of these concerns remains to be seen.