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Spain’s medtech industry federation, Fenin, has signed an agreement with an advertising self-regulation group, with the aim of helping the sector to meet legal and medico-ethical standards in this area, and so help increase trust in devices across the health system.

The assessments that Autocontrol (Asociación para la Autoregulación de la Comunicación Comercial) will perform will be secondary to all formal regulatory approvals, but are intended as an added layer of quality-assurance. As for the decisions reached by a dedicated panel of experts in relation to disputes regarding product information or advertising claims, such decisions will be binding.

A readily-identifiable logo will help verify the quality of the product information. This might appear to be aimed principally at lay consumers, i.e the general public. However, the initiative is targeted at the wider health system too, Fenin explained after signing the agreement on 24 June.

€1.4bn Obsolescence Bill

The drive to increase the commercial competitiveness of Fenin members, by essentially adding weight to a product’s clinical- and cost-effectiveness claims, comes amid evidence that the Spanish health system is failing to meet equipment renewal needs.

Investment in medical technology across the public and private sectors remains below sustainable levels in Spain, thereby exacerbating a long-standing obsolescence problem, Fenin has warned.

In 2018, aside from a handful of positive developments, the overall high-tech medtech market had shrunk, according to an analysis commissioned by Fenin. While highlighting a year-on-year contraction of 6% in electromedical equipment spending, it said that an exceptional 24% rise in medical imaging spending was due only to a one-off (cancer care-focused) €320m donation by the Amancio Ortega Foundation.

Fenin underlined the persisting problem of putting price before quality in making purchasing decisions. There must be a recognition that investment in equipment is a cost-saving strategy, it said.

The cost of bringing Spain’s medical equipment renewal rates up to the standards of elsewhere, across the public and private sectors, is put at €1.4bn ($1.58bn). That allows for the necessary updating to be completed within four years, Fenin told health-care authorities at an industry-government meeting in January.

Fenin also underlined the need for greater investment in human and economic resources at the health-care products regulatory agency and notified body, AEMPS (the Spanish Agency of Medicines and Medical Products), in order to help it to better respond to the market needs generated by the EU’s new medtech regulations. AEMPS recently decided to end its servicing of file submissions under the EU medical device directives, given the pressure on time that will come with the new Medical Device Regulation (MDR) (Also see "Spain’s Only Notified Body Sets Time Limits For New Customers And New Products" - Medtech Insight, 3 Jun, 2019.)

Going forward, there is, however, a silver lining: The “adoption of new medical technologies” is one of the three key policy-development areas of the recently-renewed Spanish health system (SNS) advisory committee (Consejo Asesor de Sanidad y Servicios Sociales).

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