Tag Archives: science

Disclosure Day: Drones in the EU – What’s Flying Above Us (and No, It’s Not Aliens)

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With the recent wave of U.S. government declassifications of UFO files – officially referred to as UAPs (Unidentified Aerial Phenomena) – and a new Spielberg film tapping into our fascination with the unknown, the skies have never felt more mysterious. Yet, before looking up in wonder, a more grounded reality emerges: most of what we see overhead is far more explainable. Drones, for instance, are quietly reshaping our airspace – and the European Union has already put in place a comprehensive regulatory framework to govern them.

The Regulatory Framework: Two Regulations, One Clear Sky

Since 2019, two EU regulations have governed the production and operation of Unmanned Aircraft Systems (UAS) across all Member States, ending years of fragmented national rules.

Regulation (EU) 2019/945 – Manufacturing and Market Requirements

This regulation sets out the technical requirements for drones placed on the EU market, introducing a classification system based on maximum take-off mass (MTOM) and operational characteristics:

  1. Class C0 – under 250g; minimal requirements, no Remote ID required
  2. Class C1 – 250g to 900g; Remote ID mandatory, restrictions near populated areas
  3. Class C2 – 900g to 4kg; Remote ID, low-speed mode, geofencing capability required
  4. Class C3 / C4 – up to 25kg; reserved for “Specific” category operations
  5. Class C5 / C6 – designed for advanced operations, including drone swarms and controlled BVLOS flights

All drones must carry CE marking confirming conformity with their class requirements. From Class C1 upwards, every drone must be equipped with Remote ID, i.e. a real-time digital identification system that continuously broadcasts the drone’s unique identifier, position, altitude, speed and the operator’s location. Think of it as a number plate for the sky.

Manufacturers not established in the EU must designate an authorised representative within the Union to ensure compliance.

Regulation (EU) 2019/947 – Operational Rules for Pilots and Operators

This regulation, developed by EASA (the European Union Aviation Safety Agency), governs how drones are actually flown, organising all operations into three categories based on risk level:

Open Category – low-risk flights requiring no prior authorisation. Operations must remain within visual line of sight (VLOS), below 120 metres, and away from gatherings of people. This category is further divided into three subcategories (A1, A2, A3) depending on the drone’s class and its proximity to uninvolved persons. Subcategory A2, for instance, requires pilots to pass a theoretical examination before operating a Class C2 drone near people.

Specific Category – medium-risk operations that generally require either an authorisation from the national competent authority or compliance with a pre-defined Standard Scenario (STS). Authorisations are based on the SORA methodology (Specific Operations Risk Assessment), which helps assess the level of risk involved and determine what safety measures are needed. Two Standard Scenarios are currently available – STS-01 (visual line of sight flights in populated areas) and STS-02 (beyond visual line of sight flights in unpopulated areas). Operators meeting all the conditions of an STS can fly under a simple declaration, without needing individual authorisation.

This category is also where BVLOS operations (Beyond Visual Line of Sight) come in – flights where the drone operates beyond the pilot’s direct visual contact. BVLOS is key to unlocking use cases like long-range infrastructure inspection, medical delivery, and large-scale surveying. These flights typically require either a SORA-based authorisation or compliance with STS-02, and the drone must be equipped with detect-and-avoid capabilities to ensure safe separation from other aircraft.

Certified Category – high-risk operations equivalent in complexity to conventional aviation. Requires full EASA certification of the drone, a formal operator approval, and a licensed pilot. Reserved for operations where a system failure could have catastrophic consequences.

Cross-Cutting Obligations

Regardless of category, all operators must:

  1. Register with their national competent authority (mandatory for drones over 250g or equipped with a camera)
  2. Respect UAS geographical zones defined by each Member State, covering restricted, prohibited, and conditional airspace
  3. Maintain flight logs for all Specific and Certified category operations
  4. Ensure adequate pilot training appropriate to the subcategory or category of operation

The U-Space: Managing the New Low-Altitude Frontier

The two regulations sit within a broader framework that includes the U-Space system, established by Regulation (EU) 2021/664. U-Space is the EU’s digital infrastructure for managing low-altitude air traffic in real time – essentially an air traffic management system for drones. It enables flight authorisation, conflict detection, real-time traffic monitoring and information sharing between operators, authorities, and conventional airspace managers.

U-Space is the critical enabler for large-scale BVLOS operations, and its progressive rollout across Member States is expected to unlock entirely new categories of drone deployment in the coming years.

Why It Matters

Together, these regulations created a single European drone market: harmonised, scalable, and built around safety. For anyone operating drones professionally in Europe, compliance is not optional – it is the foundation of lawful and sustainable operations.

So while the debate on UAPs continues across the Atlantic, Europe has already answered its own version of the question: what’s flying up there, and who’s in charge of it?

The answer, refreshingly, involves neither little green men nor government cover-ups – just well-drafted regulations and a lot of paperwork.

Vaccines: the Italian Constitutional Court rules in favor of mandatory vaccination imposed by national law

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The polarized debate over vaccines sees the Italian Constitutional Court taking an important step into the discussion, shortly before the last notable rebellion against compulsory vaccination in Italy. Only a few days ago, in fact, the Mayor of Rome, Ms. Raggi (together with the members her Council, unanimously), approved a motion contradicting the mandatory nature of the 10 (originally 12) vaccinations, made compulsory for school-age children by a recently enacted Italian law. Nevertheless, the “rebels” in Rome probably did not take into the appropriate account the decision of the Italian Constitutional Court, which ruled in favor of the vaccines imposition under Italian law.

The Court – in deciding a constitutional challenge brought by the Veneto Region against the imposition of vaccination by the State – explains its views in a straightforward way.

First of all, the Court makes it very clear that, when it comes to vaccines, fundamental health care rights are involved and, to such regard, no difference is constitutionally acceptable between different areas of the Italian territory. In other words, when a healthcare measure is imposed by a national law in the public interest, Regions and local authorities do not have a say about it.

Furthermore, and most importantly, the Court clarifies that – also taking into account the worrisome drop in vaccination rates in recent years – the choice of tightening up legislation to compel vaccinations is not unreasonable.

True, persuasive techniques – such as the ones that Veneto Region would like to implement – can, ideally, represent a better option, but only when the herd immunity result is somehow guaranteed. Conversely, when vaccination rates drop, obligations and sanctions by law – as the California example showed – are not only reasonable (and constitutional), but much more effective.

Well, when the going gets tough, the law gets going. And that’s reasonable, Italian Constitutional Court says.

Vaccination: an Issue between Policy, Science, Justice and Evidence.

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The issue of vaccination, once simply relegated to the realm of medical science, has become increasingly political in the past few years. All of a sudden, you must be either strongly pro or fiercely against vaccines, as if this were a religious or civil rights issue. (Welcome to our new, polarized world).

THE EUROPEAN UNION COURT OF JUSTICE ON EVIDENCE AND VACCINES.  An interesting decision on this subject matter was issued a few days ago by the European Court of Justice. The case involved a French citizen, “Mr. W”, who “was vaccinated against hepatitis B through three injections, administered on 26 December 1998, 29 January 1999 and 8 July 1999, of a vaccine produced by Sanofi Pasteur. From August 1999, Mr W began to present with various troubles, which led to a diagnosis of multiple sclerosis in November 2000”. The case of Mr. W has been decided many times in France, where in some instance a causal link was found, while it was denied in other decisions.

The EU Court was requested to provide guidance on two questions relating to the interpretation of EU law on product liability and based its decision on the assumption that “medical research neither establishes nor rules out the existence of a link between the administering of the vaccine and the occurrence of the victim’s disease”.

The EU Court concluded that:

  1. National evidentiary rules are not precluded by EU product liability law so long as the burden of proof remains on the plaintiff who must prove the damage, the defect and the causal relationship between the defect and the damage; and

 

  1. National evidentiary rules are precluded based on presumptions according to which the existence of a causal link between the defect attributed to the vaccine and the damage suffered by the victim will always be considered to be established when certain predetermined causation-related factual evidence is presented.

 

The decision was harshly criticized as possibly opening the floodgates of vaccines litigation without requiring the plaintiff to actually prove a causal link. In this New York Times article, Dr. Paul Offit of the University of Pennsylvania, commented the decision by pointing out that “Using those criteria, you could reasonably make the case that someone should be compensated for developing leukemia after eating a peanut butter sandwich“. Many scientists have roared against the decision, and some pointed out that “Courtrooms are generally not a good place to decide issues of science”.

In my view, the European Court of Justice did what it usually does: interpret EU law and define the boundary between EU mandatory principles and national law. Civil procedure evidence rules are not harmonized between Member States, so I am not overly surprised by the ruling.

ITALY ESTABLISHES MANDATORY VACCINATION.  Italy has recently taken sides on the vaccination debate when on June 7, 2017 the Ministry of Health issued a law decree (n. 73) which renders 12 different vaccines mandatory (for free) for children between 0 and 16 years old. The aim of the decree is to achieve the so called “herd immunity” after which such diseases pose no threat to the entire community, as recommended by the World Health Organization. As explained by the same WHO, “Herd protection of the unvaccinated occurs when a sufficient proportion of the group is immune”.

The fear that there may be a link between vaccines and autism originated from an article appeared on Lancet in 1998 by Dr. Andrew Wakefield and his colleagues (Lancet 1998;351[9103]:637–41), which later the same British medical journal retracted since based on data that “are incorrect, contrary to the findings of an earlier investigation.” Yet, many courts have awarded damages to plaintiffs claiming to be victims of vaccination and many parents have failed to vaccinate their children.

The Italian vaccination decree arises out of a worrisome drop in vaccination rates in recent years. Anti-vaccination sentiments have been strongly voiced by the 5 Star Movement, the main populist political party in Italy with approval rates around 30%, even though they predate the rise of such movement. In the United States, a similar opinion has been held by Mr. Trump (a 2014 tweet of his read: “Healthy young child goes to doctor, gets pumped with massive shot of many vaccines, doesn’t feel good and changes – AUTISM. Many such cases!”, although his position has somewhat evolved) and consistently disputed by the medical community. The populist opposition to “big pharma”, who are allegedly making more money from vaccines than from people getting sick, often results in an anti-vaccination stance.

As the Editorial Board of the New York Times puts it, “One of the tragedies of these post-truth times is that the lies, conspiracy theories and illusions spread by social media and populist politicians can be downright dangerous. The denial of human responsibility for climate change is one obvious example; another is opposition to vaccination.”