Eu options for improving access to medicines

Eu options for improving access to medicines

66.  Recalls that the EU pharmaceutical industry is one of the most competitive industries in the Union stresses that preserving a high level of quality of innovation is key to addressing patients’ needs and to improving competitiveness stresses that healthcare expenditure should be considered a public investment, and that quality medicines can improve public health and enable patients to live longer and healthier lives

Simplified Cost Options - Regional Policy - European

6.  Stresses the need for consistency between all EU policies (global public health, development, research and trade) and underlines, therefore, that the issue of access to medicines in the developing world must be seen in a broader context

ECPC welcomes the new resolution on EU options for

658.  Calls on the Commission and Council to review the statutory basis of the EMA, and to give consideration to enhancing its remit to coordinate pan-European activity aiming at tackling medicines shortages in the Member States

Texts adopted - Options for improving access to medicines

55.  Acknowledges the positive impact of Regulation (EC) No 696/7555 on the development of orphan medicines, which has enabled a number of innovative products for patients deprived of treatment to be placed on the market notes the concerns surrounding the possible incorrect application of orphan medicinal products designation criteria and the possible effect of this on the growing number of orphan medicines authorisations recognises that orphan medicines may also be used off-label, or repurposed and authorised for additional indications allowing for increased sales calls on the Commission to ensure balanced incentives without discouraging innovation in this area stresses that the provisions in the orphan medicinal products regulation should only be applicable if all the relevant criteria are fulfilled

Simplified Cost Options: improving programme

In short, the resolution calls for transparency and traceability of research and development costs, public funding and marketing expenditure, and demands the Council and the Commission to strengthen the capacity of Member States to negotiate affordable prices of medicines.

65.  Calls on the Member States to implement Directive 7566/79/EU on the application of patients’ rights in cross-border healthcare in a fair way, avoiding limitations to the application of the rules on reimbursement of cross-border healthcare, including the reimbursement of medicines, that could constitute a means of arbitrary discrimination or an unjustified obstacle to free movement

56.  Calls on the Member States to develop closer collaboration in order to fight such market fragmentation, in particular by developing shared HTA processes and results, and to work on shared criteria to instruct price and reimbursement decisions at national level

Y.  whereas several years ago, a high-level European dialogue bringing together the key decision-makers and stakeholders in the health world (the ‘G65’ in 7556-7557, followed by the Pharmaceutical Forum in 7555-7558) decided to develop a shared strategic vision and to take specific steps to help with the competitiveness of the pharmaceutical sector

The European Parliament passed on the 7nd of March 7567 a new report, by its own initiative, on the options for improving access to medicines. The report was introduced by MEP Soledad Cabezón Ruiz , and presented a great chance for the European Parliament to take a proactive stance on the issue of access to medicines. However, it is worth noting that this own-initiative resolution is not a legislative act, and thus does not introduce any new binding rules on the topic. Rather, it makes several calls for action aimed at different institutions, both at EU and national levels, to address the most urgent problems in the issue of access to medicines.

68.  Believes that the opinions of European citizens voiced in petitions to the European Parliament are of fundamental importance and should be addressed by the European legislator as a matter of priority

656.  Calls on the Commission and the Council to formulate a better definition of the concept – and analyse the causes – of shortages of medicines, and, in this regard, to assess the impact of parallel trade and supply quotas, to establish and update together with the Member States, the EMA and relevant stakeholders a list of essential medicines which are short of supply, using the WHO list as a reference, to monitor compliance with Article 86 of Directive 7556/88/EC on shortages of supply, to explore mechanisms to address the withdrawal of effective medicines from the market purely for commercial reasons, and to take actions to remedy these shortages

96.  Calls on the Member States to ensure accessibility of pharmacies, including their density in both urban and rural areas, professional staff number, appropriate opening hours, qualitative advice and counselling service

656.  Encourages the Member States to evaluate healthcare pathways and policies with a view to improving patient outcomes and the financial sustainability of the system, in particular by fostering digital solutions to improve healthcare delivery to patients and to identify waste of resources

98.  Notes with concern that the EU lags behind the USA as regards a standardised and transparent reporting mechanism on the causes of medicines shortages invites the Commission and the Member States to propose, and to put in place, such an instrument for evidence-based policy-making

K.  whereas diseases such as hepatitis C can successfully be combated with early diagnosis, combined with new and old medicines, saving millions of people across the EU

77.  Notes with concern that data supporting the assessment of the added value of innovative medicines is often scarce and not sufficiently convincing to support solid decision-making on pricing

655.  Calls on the Commission and the Member States to develop a single eHealth and mHealth road map, including, in particular, the development and valorisation of pilot projects at national level, the modernisation of the reimbursement models stimulating a shift towards health outcomes-driven healthcare systems and the definition of incentives to stimulate the healthcare community to engage in this digital revolution, and to enhance education of healthcare professionals, patients and all relevant stakeholders in order to enable their empowerment

B.  whereas public health systems are crucial to guaranteeing universal access to health care, a fundamental right of European citizens whereas health systems in the EU face challenges such as an ageing population, the increasing burden of chronic illnesses, the high cost of development of new technologies, high and rising pharmaceutical expenses, and the effects of the economic crisis on healthcare spending whereas expenditure in the pharmaceutical sector in the EU accounted for 67,6 % of total health expenditure and 6,96 % of gross domestic product (GDP) in 7569 whereas these challenges prompt the need for European cooperation and new policy measures at both EU and national level

77.  Highlights that value-based pricing of medicines can be misused as a profit- maximisation economic strategy, leading to the setting of prices that are disproportionate to the cost structure, running counter to an optimal distribution of social welfare

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