The Minister of Health, Mónica García, does not win for dislikes in Europe about her Royal Decree of the Comprehensive Plan for the Prevention and Control of Smoking that aims to modify the Spanish regulations of 2017. Six countries presented their “reasoned exhibitions” in the TRIS process of the European Union, as the reason advanced. Italy, Sweden, Romania, Hungary, Czech Republic and Greece blocked with their criticism the Spanish project until July 28, date on which the European Commission will publish its opinion, which is predicted negative and that will leave the Royal Decree in borage water.
The European Commission expresses its concern for some definitions included in the Spanish proposal that extend or modify the provisions of the European Directive, departing from the legal framework of the European Union itself. According to their observations, these definitions can generate insecurity about which products are really regulated, which makes it difficult to be consistent with the regulations in all member countries. One of the most sensitive issues is the classification of certain products, such as nicotine sachets, which in the Spanish project are treated as if they were part of the tobacco universe. The Commission indicates that this interpretation is not supported by current European regulations, so they should not be part of this royal decree if you want to maintain a harmonized regulation throughout the EU.
In addition, Brussels remembers Spain that it should evaluate the economic impact of these measures on the business environment. According to the Commission, more balanced legislation should take into account how new standards affect competitiveness, industrial development and innovation. It also recommends following principles of good regulation. These appreciations are in the line of the allegations presented by these six countries and are overwhelming.
From the outset, there is a broad consensus that Spain has not presented sufficiently solid reasons not to adopt less restrictive or more efficient solutions, such as a prohibition of the product exclusively to minors or the adoption of certain demands in the packaging. They also claim that the measures proposed by Spain conflict with the fundamental norms of the common market since they restrict the entry and circulation of certain products without a clear or proportional justification. In particular, most governments indicate that the nicotine limit provided for bags is excessively low and does not fit the values that are accepted in other countries, where a much greater concentration is allowed.
In conclusion, the first criticisms contained in the reasoned exhibitions and in the criteria of the Commission consider that the RD generates legal insecurity because it changes key definitions of European regulations on tobacco products. This allows nicotine bags to be de facto, so different countries believe that this prohibition goes against the principle of free circulation of goods in the European Union and violates articles of the EU operation treaty (articles 34 to 36). They also criticize that the nicotine limit proposed in Spain (0.99 mg over) is too low, and reproach that Spain has not considered less drastic measures, such as labeling or restriction by age, nor has it justified well why it wants such a strict regulation, as the National Commission of Markets and Competition had already criticized.
The CNMC requires that the Ministry recognize the constitutional right of free enterprise and that restrictions have empirical and scientific evidence. The issue is that the ministry is limited to restricting electronic cigarettes or nicotine bags, leaving without alternatives to a group of 1.8 million people, which will return to traditional tobacco if the Comprehensive Plan for Prevention and Control of Smoking is approved. And a fact to consider: 80% of smokers who want to leave tobacco fail because they do not have an alternatives. The same as the allegations of these countries point. Sweden, the only European country free of smoke, is the most crude in its allegations because it attentive to its anti -tabaco policy that is based on the promotion of alternatives. For example, the Nordic country defends that nicotine bags can be useful as a tool to reduce smoking and criticizes that Spanish measures do not take into account more balanced options that avoid a total veto to the product. They emphasize that it is a disproportionate regulation.
In the elaboration of the plan, the Ministry refused to meet with the sector and the resulting text has demonstrated a deep ignorance of European regulations ignoring the regulation of fourteen countries on electronic cigarettes or nicotine bags. Romania is the most explicit country in its criticisms in this area, as well as Sweden, for the Spanish attempt to reduce to 0.99 milligrams the content of the nicotine bags because they intuit an attempt to ban this product and consider that if they cannot use them as an alternative to the traditional cigarette, users can return to tobacco or look for them in the submerged economy. And more. In some of these countries doctors prescribe to electronic cigarettes or nicotine bags, something that Spanish oncologists also defend.