In part one, we covered the regulatory framework, compliance, and Wholesale Distribution Authorization. In part two, we’ll explore how success in Europe goes beyond regulatory approval—it’s also about commercialization, pricing, and long-term market access. We’ll dive into the importance of pharmacovigilance and the country-specific nature of pricing and reimbursement.
Pharmacovigilance (PV) systems add another layer of complexity to bringing your drug to market in Europe.
The EU PV system is among the most comprehensive in the world. It is a key function of public health that aims to increase the benefits and reduce the risks of medicines. Some of the core requirements include collecting and managing safety data, detecting signals in the data, and informing stakeholders and the public of new or changing safety issues.
While the EMA may grant centralized marketing approval of a drug for use in Europe, local safety requirements can and do vary across the EEA. Integrating local customs and laws specific to how medical information is communicated and managed in a country is key to a successful PV system.
Overview of key requirements:
Finding QPPVs and LPPVs can be particularly time-consuming and resource-intensive for pharmaceutical companies, especially if there are language differences. Therefore, a business partner with an extensive network of qualified candidates to fill these roles quickly is one way to ensure your product launch timeline stays on track.
The pricing and reimbursement of drugs in EU are highly country-specific due to the diverse healthcare systems and regulatory frameworks in each member state.
Each member state of the EU sets its own drug price and reimbursement status. Typically, the national health authority of the individual country working with reimbursement and health technology assessments (HTAs) is responsible for this process.
Many EU countries use International Reference Pricing, where the price of medicine is benchmarked against the prices in a selection of other countries. In other countries, prices may reflect the clinical value and health outcomes delivered by the medicine called Value-Based Pricing, usually presented in a health economic evaluation.
Some of the health economic key components in a Health Technology Assessment (HTA) to assess the value of medicine and justifying the price of a medicine include:
While there is some harmonization through the EU Transparency Directive , which ensures that pricing and reimbursement decisions are based on objective and verifiable criteria, the implementation of these criteria can vary significantly. This means pricing and reimbursement decisions are primarily the responsibility of individual EU member states, where each country has its own set of rules and procedures for determining the prices of medicines and their reimbursement status.
Reimbursement in some countries like Sweden and France use HTA to evaluate the cost-effectiveness of a drug before it is approved for reimbursement, while in other countries medicines are fully reimbursed by public or private insurers. Some EU countries also engage in collaborative purchasing agreements to reduce costs, particularly for high-cost medicines.
Our experts understand the country-specific needs and differences and can support with comprehensive approaches towards successful market access, and this includes the right pricing and reimbursement in each European member state.
When it comes to bringing a drug to market in Europe, expertise with local knowledge and reach is a must.
With local affiliate services across Europe, our local experts provide a deep understanding of both EEA and country-specific regulations so that your products meet all the necessary requirements from launch throughout the product lifecycle.
Learn about ProPharma’s full range of services and how our cross-functional approach can help your organization. Contact us today to ensure your launch strategy aligns with European regulatory requirements.