Celiac disease, cuts and debates over dispensable products


The Ministry of Health has updated the maximum spending limits for the provision of gluten-free foods to people with celiac disease.However, the cuts also affect some categories of foods valued by the celiac community. Between debates and court actions, issues of ‘governance‘ and competition to be addressed at the political level.

Celiac disease and free product dispensing

The care of patients with celiac disease

by the National Health System (


) is based on the contribution to the expenses they incur for the purchase of food ‘

gluten-free, specifically formulated

for celiac disease

‘ (o ‘

gluten-free, specifically formulated for people who are intolerant to gluten

‘). (1)

The gluten-free diet is in fact the only available treatment for those with this social and endemic disease. Who need to receive foods that are able to meet their specific nutritional needs at every stage of life, from early childhood to later life.

Contributions to the purchase of the above products by the NHS are subject to an individual spending limit, on a monthly basis, which the Ministry of Health periodically updates. Depending on the age group and gender of the patients, the contribution today ranges from a minimum of €56/month (for children aged 6 months to 5 years) to a maximum of €124 (for males aged 14-17). However, the way vouchers are handled varies from region to region, to the detriment of users who are often forced to refer only to pharmacies instead of supermarkets. (2)

First and foremost, the revision of spending caps responds to the need to reduce public health costs. Italy remains one of the most generous countries on the planet on this item of the health budget, which now affects 198,000 people. (3) The Italian Celiac Disease Association, AIC, has worked alongside the Ministry of Health to maintain access to basic substitute products, also taking into account the decreasing prices of ‘gluten free‘ foods. (4)

Register of products dispensable to people with celiac disease, what’s new

The Ministry of Health Decree 10.8.18-in addition to lowering the levels of the public contribution threshold (-19%)-introduced cuts to the categories of products subject to free dispensing. (5) Restricting reimbursability to the following 5 categories:

1. bread and related items, savory baked goods,

2. pasta and related, pizza and related, ready-made pasta dishes,

3. ready-made preparations and bases for cakes, breads, pastas, pizza and the like,

4. baked goods and other confectionery products,

5. breakfast cereal. (6)

As a result, a number of foods on which the broad celiac community has hitherto been able to rely have been removed from the Registry of Dispensable Products. (7) Although the same were ‘specifically formulated for celiacs’ and registered as such. With also substantial investment in both research and development, sales promotion (including so-called listing fees imposed by the large-scale retail trade) and advertising.

Products excluded from the registry, issues of
and competition issues

The process of revising the ministerial decree and the corresponding guidelines, while coordinated by the Ministry and AIC, did not involve the very many operators (including many SMEs) who over the years have been working to formulate ad hoc products aimed at this category of consumers.

Instead, the consultation was limited to the few industries that dominate this profitable market segment. Which as early as last August knew about the regulations in the making and had a chance to discuss them. With inevitable repercussions on competition, as other operators suffered the winter ‘cold shower’ of seeing their products instantly excluded from the Registry, without any notice or transition period.

The habits and expectations of the couple of hundred thousand affected celiacs, moreover, do not appear to have been verified in concrete terms by means of appropriate surveys, online and offline, on the roster of foods useful in composing a varied, as well as healthy and balanced diet. The path of revised standards has thus, inevitably, generated tension and debate.

Basically, someone decided

in secret which – among the very many foods ‘
specifically formulated for celiaci’, duly notified to the Ministry – can continue to be provided free of charge to those with celiac disease. And which ones do not. And who made that decision, according to what criteria? Certainly not the 200,000 coeliacs who already have difficulty buying products in supermarkets, where they cost much less than in pharmacies. As well as the difficulty/impossibility of receiving refunds on products purchased outside the region of residence.

Products excluded from the registry, hot topics

Breaded products-such as ‘hamburger (stuffed bun), cutlets, chicken nuggets, arancini, and supplì‘-were suddenly excluded from delivery. As ‘not essential for the celiac’s diet,’ in the opinion of AIC. (8) Which, evidently, did not consult Sicilian celiacs or the manufacturers who cater to them. Thus Mr. Giuseppe Glorioso of I.Ca. s.r.l. – pioneering company, in Sicily, in research and development and production of gluten-free foods –
filed an appeal with the Lazio Regional Administrative Court.


The Lazio Regional Administrative Court temporarily suspended the effectiveness of the Register (as updated on 10/24/18) and related acts, in the part pertaining to the exclusion of meat foods from the list of dispensable products, until the chamber hearing on 12/2/19. (9) At that hearing, the adjudicating panel will consider the report meanwhile requested from the Ministry of Health, ‘in whichthe reasons (resulting from the procedural investigation) are given for why it was decided to exclude meat foods.’

The hot topic

, far more than gluten-free arancini, is the lack of


mentioned in the previous paragraph. A deficiency that is certainly not the fault of the Ministry of Health and indeed is found with even greater frequency in other ministries, two above all Environment – eloquent the ‘
sludge case’
and Agriculture.

A structural reform of the modus operandi of public administration is incumbent on the government. Almost 30 years after the Bassanini Law came into force, the criterion of transparency of administrative acts should be affirmed as early as the various stages of their development. Providing for online public consultation of all stakeholders, i.e., interested social partners, and effective consideration of registered petitions. As is the use of the European Commission and many national administrations (China and the US above all).

As for the Registry of Dispensable Products, a suitable solution must be found to ensure the immediate reintroduction of excluded foods without notice until the reform is publicly concerted. Without neglecting the possible involvement of the Antitrust Authority (AGCM), in relation to the implications of the path adopted so far on both the competitiveness of the companies involved and the rights of consumers.

Dario Dongo


(1) See Law 123/05. See also DM 17.5.16, Article 1, and DM 10.8.18, Article 1

(2) It seems indispensable, in this regard, to define the relevant LEAs (Essential Levels of Care), which must provide for the possibility of making purchases at large-scale retail outlets and online, using shopping vouchers that must also be made available in digital format

(3) Free ‘ad hoc’ alimony provision is recognized only in Belgium (€38/month), France (€46), Denmark and Norway (the best). Serbia and Croatia guarantee only ‘gluten free‘ flour (for €5 and €10/month respectively), England some ‘staple food‘ on prescription. Russia, Germany, the Netherlands and Portugal recognize partial tax deductions

(4) From 2001 to the present (in spite of the tragic ‘euro effect’) there has indeed been a significant decline in the prices of gluten-free bread, pasta and flour, -7% in pharmacies and -33% in large retailers

(5) See Ministry of Health decree 10.8.18,
Expenditure ceilings for the dispensing of gluten-free products, referred to in Article 4, paragraphs 1 and 2 of Law No. 4 of July 4, 2005. 123, bearing: ‘Standards for the protection of individuals with celiac disease”
, at


(6) See the Guidance Table Min.Sal. On deliverables, on http://www.salute.gov.it/imgs/C_17_pagineAree_3667_listaFile_itemName_7_file.pdf

(7) The ‘National Register of Foods for Special Medical Purposes, Gluten-Free and Infant Formulae,’ established at the Ministry of Health pursuant to DM 8.6.01, Article 7

(8) See AIC press release, date unknown, at.


(9) See Judgment TAR Lazio, Section Three Quater, Order 13.12.18 on appeal r.g. no. 12978/2018, on https://www.giustizia-amministrativa.it/cdsintra/cdsintra/AmministrazionePortale/DocumentViewer/index.html?ddocname=NO2C3DROCAZL34BONF276KDIY4&q=glutine

+ posts

Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.