Patients’ Access to Medicines
Significant reforms of healthcare systems are underway around the world. The European pharmaceutical industry is keen to lend its expertise to these discussions to help ensure that the end results include increased access to innovative treatments for patients and expansion of healthcare coverage to lower-income populations.
The biggest challenge currently facing Europe’s health systems is sustainability. The EU’s reflection process on chronic diseases is an opportunity for change that must be taken, given that these diseases make up a large proportion of healthcare costs. Building on the EU competence in the field of public health, the European Commission could take a more active role in facilitating and co-ordinating the exchange of national and regional best practices in the field of prevention of chronic diseases, as well as evaluating them. This could include experiences with health promotion programmes, involving multiple relevant stakeholders – employers, the workforce, and health insurers – or with the implementation of patient registries. Along with the transfer of ideas and knowledge, models, tools and solutions that can be used in other countries could be developed, promoted and implemented.
The industry is also promoting new thinking about how we improve patients’ adherence to treatment. The issue is one of the most pressing facing healthcare systems in Europe. The reasons for non-adherence are complex, as are the factors that define how well individuals manage their health. Improving health literacy should be a priority, not least in light of the need to address chronic disease.
Health information is an important consideration of how to enhance patient empowerment, but also in terms of what role, if any, industry can play in providing information to patients. EFPIA believes that empowerment involves a change in the patient’s role in the healthcare system, but we are still in the early stages of understanding what sorts of informational supports are most useful for patients.
Patient safety is fundamental to everything we do as is promoting confidence among patients on the safety of the medicines they are prescribed. Great efforts have been put into updating the legislative framework on falsified medicines. The next phase is the implementation of the legislation throughout EU Member States and ensuring that patients and their physicians are properly informed. The implementation entails adopting a harmonised tracking system for medicines to guarantee the reliability of the supply chain. To this end, the pharmaceutical industry is - together with key supply chain partners - involved in setting up an EU-wide coding and serialisation system, the European Stakeholder Model (ESM), aimed at ensuring the safety of the supply chain through an interoperable and cost-effective system across the EU. According to the European Association for Access to Safe Medicines (EAASM), 60% of medicines purchased online are falsified, fake or substandard. As more and more patients look to the Internet for the supply of medicines, EFPIA is committed to protecting their safety and promoting access to safe and efficacious medicines, advocating for robust patient education and awareness, and combating unsafe medicines, including those sold by illegitimate online pharmacies.
Pharmacovigilance is a key public health function and there is a need to strive to ensure its effectiveness, so that patients continue to access safe medicines. There is a wide range of stakeholders integral to this process, from patients to doctors and regulatory authorities. Therefore, it is important to consider the appropriate level of involvement of these different stakeholders to ensure the process is not complicated more than necessary. EFPIA has consistently been supportive of efforts to strengthen, rationalise and streamline the EU’s pharmacovigilance system.
Clinical trials should allow increasing numbers of patients to benefit from innovative medicines that are still in development. Between 2005 and 2010, over 297,000 patients took part in clinical trials in Europe. This represents around 40% of trials conducted globally for that period. Despite this, Europe’s clinical trials infrastructure remains fragmented. This discourages investment and limits opportunities for participation. Furthermore, with the revision for the EU Clinical Trials Directive under discussion, the European pharmaceutical industry is seeking for more streamlined procedures that are better adapted to the new science in order to get innovative medicines to the patient more quickly.