1. Public payers and pharmaceutical manufacturers have a shared interest in enabling timely access to necessary and innovative medicines. At the same time, there is a tension between the interests of purchasers (to contain costs) and of manufacturers (to provide return on investment and maximize profits).2. The most common pricing mechanisms in Europe - such as external reference pricing (ERP) and managed entry agreements (MEAs) - tend to create incentives for pharmaceutical companies to give confidential discounts on the official list prices. This obscures the actual prices paid for medicines.3. Net price transparency (NPT) for pharmaceuticals - the public disclosure of prices paid to manufacturers - is seen by many as key to overcoming the opacity of pharmaceutical systems and to addressing the imbalance between countries with different levels of negotiating power (as larger or smaller purchasers, or richer or poorer countries). It is also regarded as a means of ensuring that public payers purchasing pharmaceuticals for their populations can be held accountable.4. However, policy action on NPT is not straightforward:1.1. Empirical evidence on the effect of NPT is extremely limited. Economic simulations do not provide a clear answer and evidence from natural experiments only comes from very specific settings, not least because NPT policies have never been fully implemented.1.2. Some policy-makers are concerned that moves towards increased price transparency would have a negative impact on accessibility, because pharmaceutical companies may then withdraw from markets or set prices at unaffordable levels, in particular in cases of less attractive (e.g. smaller) markets.1.3. Payers in different health systems may consider measures to increase price transparency for pharmaceuticals as more or less necessary to increase affordable access to medicines.5. Any movement towards NPT requires a re-examination of the established trade-offs in pharmaceutical policy in Europe and worldwide. It is important to consider:1.1. the differing needs and negotiating capacities across countries1.2. the complexities of the interactions between stakeholders1.3. the particularities of specific market segments1.4. the way the process of implementation may shape the policy's impact1.5. the consequences for different countries and the 'knock on' implications of these effects for availability and affordability in other (national) health systems1.6. the likely implications for innovation.6. Increasing transparency in the pharmaceutical system will require greater European and international collaboration - strengthening and going beyond existing initiatives. It also demands a clear focus on maintaining access, innovation and sustainability. Recent experience with joint purchasing, such as in the case of the COVID-19 vaccines, may bolster similar initiatives in future.

1. Policy-makers and purchasers increasingly face very high price tags for new medicines, and some worry that these prices challenge the financial sustainability of solidarity-based, publicly funded health care systems.2. EU Member States use a mix of policy instruments to regulate the prices and determine the reimbursement of medicines. Different policies are applied for different sectors, market segments and medicines. Some pricing, procurement and reimbursement policies are more frequently used for new, potentially high-priced medicines.3. Popular policies and tools include external price referencing, managed entry agreements, health technology assessment (HTA) and tendering, but each one of these comes with limitations.4. Adaptations of these policies, such as value-based pricing, strategic procurement and differential pricing traits, are also being explored and could be a first step in this direction.5. Further, more far-reaching measures and initiatives may also be needed to fundamentally tackle the issue of high medicine prices and to overcome information asymmetry and a lack of transparency about the real prices paid and the real development costs of medicines.6. Collaborative efforts, at both intra-country and cross-country levels, in terms of joint price negotiations and procurement and enhanced collaboration for horizon scanning and HTA appear to be promising but require strong commitment from national policy-makers.7. Pricing, reimbursement and procurement policies are important elements in the 'tool-box' to improve affordable access to new high-priced medicines but further interventions in other pharmaceutical policy areas may be required to supplement them.

This Oslo Medicines Initiative technical report presents existing policy options for payers that support innovation and access to medicines in the WHO European Region. It identifies innovation incentives, such as early assessment schemes, managed entry agreements and dedicated budgets (so-called innovation funds), across 48 countries in the Region. These incentives are supplemented by supporting assessment tools to generate evidence for informed decision-making (such as horizon scanning and health technology assessments) and access policies for innovation, such as value-based pricing, pooled procurement and subscription fee-based procurement. The report also points to possible limitations of the identified policies; some innovation policies can challenge the financial sustainability of health-care systems, and there are trade-offs between incentivizing innovation and principles of evidence generation, transparency and budget impact. Case studies demonstrate how two countries apply a mixture of policies to support innovation and access to medicines.

Transparency is important for good governance and evidence-informed policy-making for access to medicines. Based on a document review and validation of findings by national authorities, this report examines whether the public authorities, and in some cases, the public in Member States in the WHO European Region can access information about medicine prices, R&D costs and results, volumes, patent status and marketing authorization status, as outlined in World Health Assembly resolution WHA72.8 of 2019 on improving the transparency of markets for medicines, vaccines, and other health products. Across the 48 countries studied, high transparency exists for marketing authorization status and, in several countries, for list prices and volume data. Transparency was low for net prices, input costs, patent expiry dates and clinical trial results and costs. Measures to improve transparency in these areas were also identified. Price regulation, capacity-building and collaboration between public authorities were identified as key to improving transparency, and thus to informing decision-making to ensure sustainable access to medicines.

European countries have been experiencing medicine shortages due to disruptions in the supply chain. Reshoring the productions of active pharmaceutical ingredients (APIs) is considered as an approach to secure the supply. This study informs about the state-of-play of API production in the European Union, including reshoring initiatives. Studying potential benefits and challenges of local API production and the processes of reshoring, the document explores measures to facilitate the production of APIs in the European Union.