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Focus on Spain

As an aid to clients we have prepared a number of landscape pieces in which we share a summary of the key aspects which affect pricing and reimbursement rates, as well as market access in each of the markets. This article focuses on Spain.

Background

The Spanish government is the primary payer stakeholder, and the National Health Service oversees new drug approvals via the Agency of Medicines and Medical Devices. The Directorate General for Pharmacy and Health Care Products (DGFPS) makes decisions about price. The National Health Service is largely funded through national and regional taxes, supplemented by co-payments for pharmaceuticals and outpatient care. Patient co-payments for pharmaceuticals are regulated at both national and regional level. Unique to Spain is the role of the 17 regional Autonomous Communities, each of which determines budgets and reimbursement guidelines. Supporting the costs of treatments approved at the national level is a major responsibility for the regional payer authorities. There are 17 regional ministries or departments of health with primary jurisdiction over the organization and delivery of health services within their territory, thus health expenditure is mainly determined by the regional administrations.

Key Processes

In Spain:

• The government is the primary payer stakeholder, and the National Health Service oversees new drug approvals via the Agency of Medicines and Medical Devices.

• Marketing authorization is granted either by the EMEA or the Spanish Medicine Agency AEMPS (Agencia Espanola del Medicamento y Productos Sanitarios).

• The Directorate of Pharmaceutical and Health Products (DGFPS) initiates the procedure for pricing and provides guidance to the Interministerial Commission of Price of Medicines.

• The Ministry of Health (MSC) via the Interministerial Commission of Price of Medicines, decide whether or not to include new products on the national reimbursement list.

• If reimbursement status is approved then the price is agreed at the same time. If the reimbursement decision is negative, the product will be put on the negative list and price is determined by the manufacturer (“free pricing”).

• There is a Nationally binding basic benefit package laid down which in principle has to be delivered by all regions.

• The regions have a degree of freedom to impose their own pharmaceutical price caps or cost-containment targets. So whilst pricing and reimbursement are determined nationally regional bodies can impact market access.

Implications for Research Projects

The decentralized nature of Spain’s health system presents its own unique challenges for pharmaceutical companies. Reimbursement and access decisions can be taken at the regional level, and many rules and regulations can vary from hospital to hospital within a region.

In Spain it is essential to undertake research at both the National and Regional levels in order to gain insights into the possible outcomes and to understand how to influence them. This, of course, requires we recruit the right respondents:

• For all projects in Spain, the appropriate national targets would be professionals related to the DGFPS i.e. members, ex-members and clinical members of the advisory committees.

• As the regional influence is so important it is essential to include regional administration respondents in all but very early stage projects.

• If likely local uptake needs to be assessed at secondary care level the local level payors for hospital drugs will be the head of pharmacy/formulary pharmacist and the budget holder/head of clinical department.

To download this article please click on the link : Focus on Spain