This is almost becoming a tradition for the national healthcare service in Italy. Comes September… and a new spending review hits the pharmaceutical and medical device industry.

On August 4, 2015 a law decree has been approved by lawmakers, which introduces a number of new mechanisms for monitoring and reining in public spending in the healthcare sector. In particular, the new legislation has introduced several measures:

• Negotiations with current suppliers of the national healthcare service in order to achieve a 5% reduction in current spending for general supplies;
• Negotiations with current suppliers of medical devices in order to comply with the spending thresholds agreed upon between the central government and regional authorities;
• Centralized negotiations with pharmaceutical companies in order to decrease the reimbursement price of products currently reimbursed by the national healthcare service.

While measures aimed at cutting spending in connection with general supplies and medical devices have been entrusted in principle to local authorities and healthcare providers, the national pharmaceutical agency (“AIFA”) plays a central role in the envisaged mechanism to achieve savings for pharmaceutical products. In accordance with the provisions of the new decree, AIFA has indeed conducted negotiations throughout the month of September 2015, with the aim of decreasing overall spending. The new legislation provides the grouping of products in several “clusters” that include therapeutically similar products, regardless of their active principles. The lowest price in each cluster is then used as the reference price for direct negotiations between AIFA and manufacturers.

The new measures also provide that, in case of failure to reach an agreement, reimbursement by the national healthcare service may be withdrawn. However, it is also expressly provided that generic products are not admitted to reimbursement until any patents and supplementary protection certificates of branded products are definitely expired, thus providing the industry with assurances in connection with their protected drugs.

The reiterated attempts by public authorities to renegotiate prices with suppliers appear to clash not only with basic contractual principles (“pacta sunt servanda”), but also with fundamental rules of public procurement legislation. As the government (in fact, almost yearly) demands discounts on existing contracts, reliance on such contracts is affected, along with transparency and open competition in public procurement procedures. The truth is that the need to cut public expenditures is increasingly overriding basic tenets of contracts and public procurement law.

Med Tech and Pharma industry associations have voiced their concerns, while suggesting that efficiency and savings may be obtained by the national healthcare service through internal reorganization processes rather than by demanding additional discounts to suppliers. In fact, if we step aside from the conflicting commercial interests of suppliers (who want to maximize their revenues) and purchasers (who need to minimize their costs), we cannot but note that, again, the government appears to use cost cutting tools that focus on quantity rather than quality. On the contrary, we would expect that more emphasis should be given to Health Technology Assessment and innovation. We surely need to spend less money, but also to spend it more wisely.