Healthcare Resource Guide: Spain

Spain Statistics

Summary

Market Entry

Current Market Trends

Main Competitors

Current Demand

Registration Process

Reimbursement
Barriers
Procurement & Tenders

Trade Events

FAQs

CS Contacts
Best Prospects
Market Size

Capital: Madrid

Population: 46.7 million

GDP: $1.3 trillion

Currency: Euro

Language: Spanish

Summary

Spain has a comprehensive public health system that accounts for approximately 80% of the sector’s activity. The market for healthcare technology equipment in Spain is estimated at USD 8.5 billion for 2017 and is expected to increase between 1-2% in 2018.

Spain is no exception to the trend across the European Union to reduce health spending as governments grapple with budget deficits. Government measures to reduce the country's budget deficit over the last several years have had a substantial impact on the level of procurement. According to sector sources, the sector experienced a setback of 3% during the period 2011-2017.

The sector relies heavily on imports. Despite difficult economic circumstances and budget cutbacks, imports in 2017 increased slightly, to approximately USD 6.5 billion. The United States has approximately 25-30% of the market share, second after Germany at 50%.

Spanish exports, driven by the internal economic crisis and the need to develop new markets, have increased continuously over the past several years. Sector sources indicate exports increased by 30% over the period 2011-2015. Exports for 2017 are reported at USD 2.9 billion, up from USD 2.7 billion in 2016. The European Union (EU) accounts for 74% of these exports.

Small and medium sized companies make up 90% of the market and account for more than 40% of the turnover. Large companies account for only 8% of the market but they generate approximately 60% of the turnover. Most of the large US names are well-established in Spain, and often represent serious competition for companies trying to break into the market.

Market Entry

All medical products/equipment imported into Spain need to have the CE Mark. Because of this requirement, many U.S. companies have been centralizing their import operations into one single country where they register the products and from which they distribute their products to the rest of the EU.

Most purchases (85-90%) are made through public hospital tenders from companies that are pre-selected for public tender opening bids. That is the main reason why having a qualified importer/ distributor with access to the procurement decision makers is so important for U.S. companies. In addition, all importers/distributors of medical equipment and products into Spain need to be residents in the EU and registered with the Spanish Ministry of Health.

The import of refurbished medical equipment into Spain is technically permitted, but both public and private medical providers in Spain have traditionally preferred new equipment. Refurbished equipment also requires a current CE mark.

The official approach to vitamins and health supplements in Spain is quite different to that of the United States. Many vitamins and supplements commonly found in the U.S. health food stores are still considered by the Spanish Ministry of Health as prescription medicine and are approved as such. U.S. companies interested in the Spanish market need to provide the Spanish Ministry of Health with technical data on the product’s composition and need to meet the labeling requirements. The approval of products considered drugs can be lengthy.

U.S. products that are competitive in price or innovative in the U.S. market and that are already being sold in European markets have a better chance of success in Spain.

Current Market Trends

U.S. medical equipment is highly regarded by Spanish doctors, domestic importers, and distributors. However, concerns about the ongoing need to reduce public spending continue to limit current procurement and growth.

Spanish healthcare spending is reported at 9.3% of GDP, in comparison with 10.5% in Belgium, 11.1% in Denmark, 11.6% in France, 11.3% in Germany, 9.2% in Italy and 9.4% in the U.K., as shown in OECD statistics.

After several years of budget cuts, the national healthcare budgets are now back on course, with an increase of 2.4% proposed for 2018 (final approval of the 2018 budget was still pending by the Senate as of August 2018). However, although the Central Government authorizes the full amount of the healthcare budget, each of the 17 regional governments administers its respective budget. The result is that the distribution of the increase is uneven throughout the 17 regional governments. Per capita expenditures in 2017 ranged from USD 1,256 in Andalusia to USD 1,864 in the Basque Country. Furthermore, given the decrease in procurement during the 2008-2011 period when procurement dropped to pre-2007 levels, the recovery is slow, albeit constant.

The last few years have seen a significant shift in sourcing. In an effort to restrain/reduce expenditures, more and more items are being imported from Asia. However, when it comes to more complex and sophisticated items, quality continues to be an important factor in the purchasing decision.

Prior to the current crisis, diagnostics, orthopedics and disposable items had accounted for 70% of the market. According as the market recovers, best products will include innovative and efficient cardiology, respiratory/anesthesia, neurology, orthopedic, MRA, ETP, CT, and dermatology/wound treatment products.

Given the weight of the healthcare sector in the Spanish economy, the impact of the budgetary changes over the past several years is visible at all levels. The drop in demand, exacerbated by the ongoing, albeit shorter reimbursement delays, continues to cause serious cash flow problems for numerous distributors/importers. Contrary to their traditional way of operating, many companies currently prefer to focus their efforts on essential, basic products rather than on new products, as they are wary of making up-front investments without any guarantee of generating demand. While U.S. products are highly considered in Spain, pricing is now a decisive factor, with greater emphasis on cost-effective products and equipment rather than on innovation and quality.

Accordingly, as the economic situation improves, opportunities will arise in areas that are changing. For example, due to improving life expectancy, an aging population will generate greater demand for products directly connected with geriatric ailments and illnesses.

Likewise, EU emphasis on E-health will continue. Sector experts agree that healthcare technology is a key component to the growth of the market. However, as the rollout of this sector relies on public funding and is implemented on a regional rather than a national basis, progress in this sector will continue to be slow and the level and rate of deployment will vary from region to region.

Main Competitors

The United States and Germany are the two main suppliers, with France, the U.K., Italy and Switzerland following. However, France, the U.K. and Holland are also used as storage and redistribution centers for U.S. companies. Imports from Asia are on the rise.

Many suppliers in the Spanish industry are subsidiaries of overseas corporations, including leading U.S. firms. These well-established firms often represent serious competition for companies trying to break into the market.

Current Demand

Because of the budget adjustments over the last several years, demand for products has decreased and cost-efficiency has become a determining factor in many cases. Single use items from Asia have grown in popularity because of greater cost control. According to FENIN, the sector tendencies are as follows:

Cardiology

2.0%

Single use items

3.0%

Implants

3.0%

Wound care materials and dressings

3.0%

Home care oxygen treatment (except medicinal gas)

3.0%

Dental

2.3%

In Vitro Diagnostics

0.2%

Ophthalmology

1.2%

Systems & Technology of Clinical Information

16.7%

Registration Process

Medical products must have the CE mark and need to be registered with the Ministry of Health. The importer/distributor normally works with the U.S. company to get the product registered. Companies importing medical products need to have an authorization issued by the Ministry of Health to handle medical products. As a result of the development and expansion of the EU market and the requirement for the CE Mark, many U.S. companies have been centralizing their manufacturing and import operations into one single EU country from which they register and distribute their products to the rest of the EU.

Reimbursement

The official current repayment time allowed in Spain is:

  • Private companies up to 60 days
  • Public administrations up to 30 days
  • Public works up to 60 days.

However, despite local legislation which is in line with EU directives covering payments, common practice in Spain is that large corporations and large retailers negotiate or impose longer payment terms of up to four to six months. The Spanish government has also deferred payments in the past.

Barriers

There are no official barriers as Spain follows EU legislation regarding medical products. However, registration at the Ministry of Health can be time-consuming. Another area where differences exist is that of vitamins and health products and supplements. As is the case in other European countries, many products that are OTC in the United States are considered prescription medicines and need to be registered as such. This process can be lengthy given the different criteria for registering drugs and medicines.

Procurement & Tenders

Spanish Government procurement follows the principle of best value through competition. There is no official domestic preference policy, or discrimination against foreign suppliers, however the Spanish Government does encourage “full and fair opportunity” for Spanish suppliers.

Following below are the general guidelines for bidding on tenders in Spain. However, in the healthcare sector, the U.S. company must have an authorized representative with residence in Spain or the EU and the products must meet all EU and Spanish healthcare requirements, i.e. CE Mark, etc. Normally, authorized distributors present the bids for their U.S. partners.

In Spain, all levels of administration - central government, autonomous communities, municipalities and companies with at least 50% government ownership - have to follow specific procurement practices as regulated by the 2007 Law of Contracts of the Public Sector, Law 30/2007 of October 30 (Spanish). The authorities allowed to contract or require funds on behalf of the Government are:

  • Central Government: Ministers and State Secretaries
  • Autonomous Communities: Legal representatives as established by the local government (usually a member of the cabinet) Municipalities: the Mayor or any other formally designated official
  • State-owned companies: the Chief Executive Officer

The procedure to bid for a specific tender is relatively straightforward. All proposals for bids are confidential and must be accompanied by proper documentation. This information should include:

  • Accreditation of the legal representation used by the company.
  • Proof of economic and financial ability to meet all obligations and technical or professional competence plus a declaration that the company is not prohibited from contracting.
  • Proof that a provisional guarantee, as required by the conditions of participation, has been deposited. For foreign companies, formal acceptance of the jurisdiction of the Spanish courts (if necessary).
  • Accreditation that all fiscal and social security obligations have been met.

U.S. companies interested in bidding for contracts with the Public Administration must comply with the Spanish Public Sector Procurement Law (Ley de Contratos del Sector Público). Companies must also document their compliance with the Spanish Embassy in Washington, D.C.:

Embassy of Spain

Commercial Section

2558 Massachusetts Ave. NW Washington, DC 20008-2865

Tel: (202) 265-8600;

Fax: (202) 265-9478

http://www.spanish-embassy.com/washington.html

Procurement decisions are normally made at the respective department or agency level.

Trade Events

There are no major international trade shows in Spain for medical devices. Spanish professionals visit and exhibit at Medica, the major trade show in Germany in the healthcare sector. However, domestic congresses and conventions often including an exhibition area are organized in different areas of the country.

Please check out the links below for international events scheduled to take place in the coming months:

Local Associations

  • FENIN: The Spanish Federation of Manufacturers, Exporters and Importers of medical devices www.fenin.es
  • ASEBIO: Spanish Biotechnology Association, www.asebio.com

Government Links:

FAQs

1. Can US products be sold directly via Internet?

No, all products need to be distributed by an importer/distributor authorized by the Spanish Ministry of Health to import, handle and distribute medical products

2. Will FDA approval suffice to sell US products in Spain?

No, all products must meet EU specifications and be registered with the Spanish Ministry of Health.

U.S. Commercial Service Contact Information

Name: Helen Crowley

Position: Senior International Commercial Specialist

Email: helen.crowley@trade.gov

Phone: +34 91 4308 1548

Best Prospects

Prior to the current crisis, diagnostics, orthopedics and disposable items had accounted for 70% of the market. Although recovery has started, progress will be slow, however, demand will increase for products such as innovative and efficient cardiology, respiratory/anesthesia, neurology, orthopedic, MRA, ETP, CT, and dermatology/wound treatment products.

The area of personalized medicine will continue to prosper, especially the process of molecular diagnosis, because of its greater efficiency and individualized care. Minimally invasive technologies, primarily in the areas of cardiology and robotics, are growing more popular as well, due to the lower cost of treatment. As a result of the increasingly aged population, the demand for home care and hospice products should increase slowly but steadily according as the economy improves. While there is a good demand for disposables, Asian products are gaining in popularity because of greater cost control. With a population of nearly 47 million, Spain is an important market within the EU for medical products.

Statistics Snapshot

Market Size

100,000 millon

71,000 € million public

29,000 € private sector

Healthcare spending (including investment)

Euros 100 billon

... as percent of GDP

9.3%

... of which spent on inpatient services (including long-term care)

62.4% est. 2016

... of which spent on pharmaceuticals/consumables

16.31% est. 2016

... of which spent on investments

n/a

... of which spent on outpatient services

  • Public Health Service

14.3%

Hospitals, Procedures, Healthcare Professionals

Number of hospitals

791

…Public

345

…Private

446

Number of hospital beds

157,665

... available beds per capita

3.1 beds per 100 patients

...of which in general hospitals

127,297

...of which in specialized clinics and rehabilitation centers

30,367

Number of surgical procedures

5,051,810

...of which general and digestive surgery is the top procedure

929,122 (2015)

...of which orthopedic and trauma surgery is second highest procedure

905,906 (2015)

Physicians

247,974.

...of which surgeons

15,655

...of which internists

25,000

...of which pediatricians

6,408

Dentists

36,689

Demographics

Population

46.7 million

Life expectancy men/women

80.8/85.4

Infant mortality

3.3 deaths/1000 live births

Percent of population older than 65

18.7%

...projection, 2030

25.6%

Annual deaths

423,643

...caused by cardiovascular/circulatory disease – highest burden

117,393 – 29.66%

...caused by neoplasm - second highest

111,391 – 27.86%

Prevalence of cardiovascular and circulatory diseases – one of the fastest growing disease burden

36%


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