Biodiversity, as “the variability among living organisms from all sources” (Convention on Biological Diversity[1], art. 2), is one of the values on which today the international community most focuses its attention. This is the reason why EXPO 2015 dedicates to the biodiversity theme an entire pavillon – the so-called Biodiversity Park – whose main objective is to provide the entire world with a view on the several possibilities that biodiversity and organic farming may offer to feed the world.

The themes of biodiversity and food safety recall the debate regarding genetically modified organisms (GMOs)[2]: a matter on which the European Union intervened several times. In this regard, in order to preserve the typical biodiversity of the territories of individual Member States, the recent directive of 11 March 2015 n. 412 (Directive 2015/412/EU) – which amends the previous Directive 2001/18/EC on the deliberate release into the environment of GMOs (Directive 2001/18/EC), implemented through Italian Legislative Decree 8 July 2003 no. 224 – provides for the possibility for Member States to restrict or prohibit the cultivation of GMOs in their territory.

Until this recent directive, the cultivation of GMOs for commercial purposes had found its own discipline in the Directive n. 2001/18/EC and Regulations (EC) No. 1830/2003 and No. 1829/2003: more specifically, Regulation 1829/2003 stated that companies interested in placing on the market food and feed produced from GMOs must obtain an authorization from the European Commission after consulting the European Authority for Food Safety(EFSA).  On the basis of the subsidiarity principle, the Directive 2015/412/EU aims at ensuring to Member States more flexibility in deciding whether to cultivate GMOs in their territory[3] or not.

This national freedom should not, however, interfere with the neighboring Member States which decide to say no to GMOs: in order to avoid the unintended presence of GMOs in products – due to possible cross-border contamination by a Member State in which the cultivation is permitted to a neighboring Member State where the cultivation is prohibited – the new Directive 2015/412/EU states that, with effect from 3 April 2017, Member States, in which GMOs are cultivated, adopt specific measures in border areas of their territory to avoid any contamination.

In any case, the restrictions and prohibitions applicable under the new Directive 2015/412/EU concern the cultivation and not the free circulation and import of genetically modified seeds, as such or contained in products.

Moreover, taking into account the increasing use of GMOs in a more and more intensive agriculture, it is important to consider the protection and the circulation of these “goods” from a legal stand-point, beyond the question of biodiversity’s preservation and protection of food safety.

Nowadays, the patentability of biotechnological inventions in Italy is regulated by the Property Code (Section IV – Articles. 81bis – 81octies), as amended few years ago by the Legislative Decree no. 131/2010 implementing the Directive 98/44/EC on the legal protection of biotechnological inventions. The Directive 98/44/EC was originally implemented in Italy by Law no. 78/2006. Such law was then abrogated after the Legislative Decree no. 131/2010 came into force.

The extensive regulatory path in Italy reflects all the pitfalls and difficulties encountered by the European Community bodies in the definition of a legal framework applicable to the protection of transgenic varieties. As matter of fact, in Europe (including Italy), strong skepticism, not always justified has been felt, against GMOs, alleged of being unsafe products and hazardous to human health, often regardless of ascertained scientific proofs.

If on the one side the ethical issue on biodiversity preservation and food safety has slowed down the implementation of a proper legal framework, on the other side, the growing role of genetic engineering and technology within the industrial relations, led to the awareness that providing for adequate protection of biotechnological inventions would have become essential for the industrial Union development.

Hence the adoption of the Directive 98/44/EC on biotechnological inventions patentability, which represents the result of compromises among different positions at the European Parliament. To this end, the European Community legislator’s aim to harmonize national frameworks related to biotechnology can be explained. The Directive has therefore introduced the patent protection of transgenic varieties, providing for minimum standards for such protection, without preventing Member States from the introduction of additional limitations or qualifications.

In conclusion, to date in Italy the inventions involving GMO are patentable, but their use may be restricted in agriculture.

In this regard, the recent inter-ministerial decree of 22 January 2015[4] prohibits the cultivation of MON810 maize, originating from genetically modified seeds[5].

Previously, the Legislative Decree no. 24 April 2001 n. 212 has subjected the cultivation of seed products to a specific authorization in order to protect traditional seed products from any contact with the genetically modified products (art. 1, paragraph 2).

The Law Decree of 22 November 2004, no. 279, converted by Law 28 January 2005 no. 5, lays down the rules for the coexistence of genetically modified crops with conventional and organic farming (art. 1, paragraph 1), providing for the adoption, by the regions and autonomous provinces of the cd. “Coexistence plans“, containing “the technical rules to achieve coexistence” through  “instruments which ensure the cooperation of local authorities, on the basis of the principles of subsidiarity, differentiation and adequacy” (Art. 4, paragraph 1)[6].

Therefore, GM products are surely distributed also in Italy. The most marketed transgenic products in Italy are corn and soy (or their derivatives like: soy milk, oil seeds and breakfast flakes).

In reality, the potential adverse effects of genetically modified organisms on the environment are not yet known nor have they been scientifically proved. Differently, several tests of massive use of genetically treated plants have proven that these products can counteract against worldwide problems as the hunger in the world or global warming, which are the main topics to be dealt with during 2015 Universal Exposition in Milan. In this respect it must be considered that the “improved” soy and corn are able to protect themselves easily against intense sun and insects (saving harmful pesticides through insecticidal proteins of bacterial origin) or the GM rice (not yet distributed in Italy) with higher carotene content (being GM rice rich of A vitamin and iron) with respect to “natural” rice.

Biotechnological inventions seem therefore to be necessary for global agriculture, allowing it to adapt to climatic changes and face the food crisis.

Being EXPO 2015 on air, a renewed and more careful scientific discussion on GMOs seems necessary, leading to a likely new and even more effective and controlled “agrarian revolution”, based on the use of genetically improved products.

In this way, hopefully, the human population will be better fed and grow further. However such revolution will actually be possible only providing for clear regulations on the protection and circulation of transgenic inventions. In this way it will possible to avoid the abuse of such scientific progress or the degeneration of alteration of organisms existing in nature and thus preserving the delicate balance between biodiversity and sustainability.