Monthly Archives: February 2025

Regulation On Space Activities Under Parliamentary Examination

When it comes to human activities in space, a paradigm shift is currently taking place. Government authorities, instead of operating on their own, increasingly opt for the development of multiple forms of interaction with private operators, while the latter are keen to invest to ultimately conduct space activities in partial independence from governments. The involvement of private actors in space missions is led by technological progress and by the view of space as an economic asset.

This phenomenon implies the need for new regulations, shaping the peculiarities of the relationship between governments and private entities, while avoiding any overregulation that would constrain a rising market. The matter is, in fact, sensitive:

1) States – while wishing to interact with private entities and boost the “space economy” – are bound by international treaties and agreements.

2) Private entities need a clear delimitation of the perimeter in which they can profitably intervene, with legal certainty on the allocation of responsibilities. 

3) States and private entities ultimately need each other to harness the inherent potential of space economy. 

Today, space laws regulating the relationship between States and private operators have been adopted by more than 40 countries. Generally, States opt for an authorization system either for specific missions or for a fixed period of time.

Italy still lacks a relevant specific discipline, being merely part of international treaties regulating states’ access to outer space and space resources.

Additionally, section 189 of the Treaty on the Functioning of the European Union excludes the possibility of any harmonization of laws and regulations of EU member states in space-related policies. Thus, member states must ultimately rely on their own forces to regulate the space economy.

The good news is that Italian Parliament is currently examining a legislation, proposed on September 10, 2024, potentially able to fill the regulatory void

Specifically:

  1. the regulation would apply to space activities carried out both by operators of any nationality in Italian territory and by Italian national operators outside Italian territory;
  2. the relevant space activities virtually concern all possible extra-atmospheric human activities and are subject to authorization issued by the Government, which may involve a single space activity or several space activities of the same type or several interrelated space activities of different types;
  3. issuance of authorization is subject to objective (safety of space activities, resilience of infrastructure and, interestingly enough, environmental sustainability) and subjective criteria (including having an insurance contract and financial soundness). However, the Government’s power to deny authorization is broad and highly discretionary: authorization is in fact denied if space activity is detrimental to national interests or if there is any link between the space operator and non-democratic states.

The proposed regime for the allocation of liabilities provides for a liability of the operator for damages caused to third parties on the earth’s surface as well as to aircraft in flight and to persons and property on board of such aircraft. The liability is excluded only if the operator proves that the damage was caused exclusively and maliciously by a third party – unrelated to the space activity – and that could not have been prevented.

Furthermore, the Italian Government will be entitled to exercise a right of recourse against the space operator who caused damage to persons or property.

Will Parliament consider this framework enough to get the ball of space economy rolling? Stay tuned for the parliamentary progresses of this piece of legislation.

A new decree (and new obligations) to tackle counterfeiting in the pharmaceutical sector

On January 28, 2025 the Italian government approved a legislative decree (“Decree”) implementing EU regulation 2016/161 through which the European Union has introduced specific measures aimed at fighting counterfeit medicines.

Packaging. Packaging of pharmaceutical products will have to include: (i) a two-dimensional bar code (i.e. “unique identifier”) able to guarantee the authenticity and the identification of the single individual pack of medicinal products; and (ii) an anti-tampering device.

Marketing authorization. Any new or existing marketing authorization (“MA”) requests must include information on the unique identifier and anti-tampering device when it has an impact on the primary packaging, the locking system or the label’s legibility. MA holders must update their MA to ensure full compliance with the new regulation.

Timeline.  The Decree should come into force on February 9, 2025, but its publication in the official Gazette is still awaited. However, the Decree has provided for a transition period between February 9, 2025, to February 8, 2027, where it will be possible to continue using the old “Bollino” system without incurring penalties.

Sanctions.  The manufacturer who does not apply and activate the unique identifier may be sanctioned with an administrative fine ranging from Euro 10,000 up to 60,000 for each batch. An MA holder may be sanctioned with a fine, ranging from Euro 10,000 up to 60,000 for each batch, for trading a medical product lacking an anti-tampering device. Manufacturers, wholesalers, and suppliers of medicines to the public who do not notify immediately to the competent authorities of any case of tampering or counterfeiting may be sanctioned with a fine starting from Euro 20,000 up to Euro 80,000 for each batch.