Government and CCAA Agree on Guidelines for "Health Pact" in Spain, Pharmaceutical Sector Fears Consequences

The Spanish government and the Autonomous Communities (CCAA) came together at the Inter-territorial Council Meeting (CISNS) last Thursday (March 18) and agreed on the base guidelines for the implementation of a new "Health Pact" in the country. This pact is expected to bring short- and medium-term solutions to the system's rising financial difficulties and ensure the future sustainability and cohesion of the country's health scheme, as well as the quality and equality of the services through its territory.

These guidelines are framed in accordance with the country's Strategic Plan of Pharmaceutical Policies and are expected to create 1.5 billion euro (US$2.030 billion) in savings on pharmaceutical purchases each year; pharmaceutical purchases currently amount to 33% of the country's total health expenses. Furthermore, these measures are expected to generate 100 million euro in direct savings to patients in the country. These new guidelines are expected to come into effect next month.

Main Changes

The CISNS approved a series of short-term measures that are expected to be implemented throughout 2010 and 2011. These are divided into two segments: measures to improve the quality, equality, and cohesion of the national health system; and measures to improve the efficiency of the system and expenditure control. The main points within each of these segments are detailed below.

Measures to improve the quality, equality, and cohesion of the national health system:

• The implementation of a new norm to ensure the universality of the system.
• The implementation of a new norm to determine maximum access to services.
• The introduction of a new global vaccine scheme for all regions.
• The continuous implementation of an e-health system, the incorporation of new technologies, and the extension of the digital clinical history.

Measures to improve the efficiency of the system and expenditure control:

• The adoption of common pharmaceutical policies:
1. New calculation methods of reference prices affecting drugs that have been on the market for 10 or more years with the same active ingredient and presentation, and have a generic counterpart. New calculations will be applied to each drug group using the lower cost per treatment and per day (until now the calculation process has used the three lower costs).
2. A 25% average price cut for generic drugs. These cuts will vary on an individual basis and will take into account previous implemented cuts. As such, medications that have experienced a significant slash in prices are not expected to be affected.
3. New price cuts for sanitary products, including 20% for absorbent products (nappies), and 6% for other sanitary products.
4. A revision of the maximum reimbursement price for certain products. This will affect reimbursed prices for those drugs not included in reference-price lists, with more than 10 years on the market, and with a generic competitor in the European region; they will receive a 30% cut (previously 20%). This measure will also affect biotech drugs.
5. The introduction of selective reimbursement, which incorporates new revisions to reference prices for common treatments and a maximum reimbursement price introduced by the inter-ministerial commission. Drugs failing to comply with new prices will not longer be reimbursed by the system.
• The establishment of a new process to engage in additional pharmaceutical purchases by CCAA, and a system of sharing drug prices.
• The introduction of new strategies (educational, informative, and administrative) to maximise resources and control the use of services.

During the meeting, the CISNS also agreed on medium-term measures expected to be studied throughout the year and implemented over the following four years (2010–2013). These include:

• A new reform affecting the Fund of Sanitary Cohesion in order to boost common policies through the national health system.
• A new compensation mechanism to recover services expenses (in relation to labour-related costs).
• A price revision for medical services relating to traffic accidents.
• A revision of reimbursement process for European Union patients.
• An improvement of sanitary professionals' participation in resource allocation and administration of services.
• A revision of the needs of nurses, doctors, and other sanitary professionals in the system.
• The implementation of improved information and education systems to provide accurate data on the country's heath trends.
• The elaboration of a new strategy of services for chronically ill patients.

Pharmaceutical Industry: Future Fears

Important players from the pharmaceutical sector in Spain have become increasingly concerned over the agreed guidelines for the new health pact in the country. As reported in several media sources, companies fear losing 10% of sales, which could drastically damage profit forecasts for the year. The pharmaceutical industry association, Farmaindustria, has stated that the sector is put under too much pressure when the government relies solely on cutting drug prices to achieve pharmaceutical cost reductions. Other agencies with similar views include the National Federation of Pharmacy Offices (Fenofar), the Industrial Federation of Spanish Pharmacists (FEFE), and the Association of Manufacturers of Substances and Generic Pharmaceuticals (Aeseg). Among these institutions, special concern over generics has been evident, as this sector is suffering the most cuts (even when accounting for 9% of the total pharmaceutical expenditure in the country). Conversely, innovative drug markers are not expected to be damaged.

Outlook and Implications

Following months of work, discussions, and debates, Minister of Health Trinidad Jimenéz has finalised the first document that includes the core guidelines and foundation for the country's long-awaited health plan. The political nature of the debate and the various conflicting views on the final implementation of the plan have provided a difficult platform for the government. This is particularly true as the benefits and economic stakes of regional authorities, patients (who regard the national health scheme as one of the most valuable institutions in the country), and pharmaceutical companies could be drastically affected. Nevertheless, the "Pacto de Sanidad" is becoming a closer reality, as the collaboration between the government and the CCAAs, and the authorities' commitment to translate these guidelines into concrete strategies bring a strong foundation for the final implementation of a royal decree.