From almost every corner of the globe, the world has watched, often in horror, as conflicts erupt and societal structures crumble under the weight of violence. We grapple with the interconnected evils of drug trafficking, human exploitation and the brutal reality of civilian casualties in war zones. Yet often overlooked in the analysis is the silent enabler of the utterly unregulated and unaccountable trade in arms.

While legitimate arms industries are subject to varying degrees of national oversight and international agreements, the illicit flow of weapons operates in a shadowy realm governed by greed and violence, with scant regard for borders or human life. This clandestine network, far from being a fringe concern, has a direct and devastating impact on some of the most pressing issues facing our world today, which, based on current trends, could be responsible for 630,000 deaths per year by 2030 — more than one life per minute.

Before going into the details, it’s important to understand the endemic problem of illegal armed violence. In almost every major city around the world, the easy availability of small arms and light weapons transforms disputes into deadly confrontations. These weapons, often diverted from conflict zones, leaked from insecure stockpiles or manufactured in the black market, empower non-state actors and criminal organizations to terrorize communities and undermine the rule of law. Recent examples include the shooting of an eight-year-old girl as she sat in a car with her parents in a leafy suburb of London, through to formerly peaceful societies such as Sweden, where a surge in gang violence “has led to one of the highest homicide rates in Europe, with official data showing that fatal shootings have more than doubled in a year”, according to Euronews.

The devastating reach of illicit weaponry continues to threaten initiatives aimed at fostering peace and stability — including the Kimberley Process.”

The insidious link between illegal arms and drug trafficking is equally undeniable, as clearly illustrated in a recent report by the United Nations Office on Drugs and Crime, Global Firearms Programme and Flemish Peace Institute. Criminal cartels rely on a steady supply of weaponry to protect their operations, enforce their territories and intimidate rivals, with the profits generated helping to fuel the demand for more sophisticated and lethal arms, creating a vicious cycle of violence and corruption that destabilizes entire regions.

In terms of trade, the devastating reach of illicit weaponry continues to threaten initiatives aimed at fostering peace and stability — including the Kimberley Process (KP).

As a vital framework designed to eradicate conflict diamonds from the global supply chain, the KP relies on transparency and accountability. However, the presence of illegal arms in conflict zones remains one of the main contributors to undermining these efforts. Armed groups, fueled by illicit weapons, exploit diamond resources to finance their operations, perpetuating violence and undermining the integrity of the entire system. While the KP has directly reduced the volume of conflict diamonds out of the global supply chain from 15 percent to just under 0.2 percent, the eradication of conflict diamonds cannot be fully realized while the free flow of illegal arms continues unchecked. It is also not reasonable for groups to suggest that the KP should be responsible for arms regulation or oversight, as highlighted in my recent article.

At the same time, it isn’t enough for individual nations to operate in silo, albeit the United Arab Emirates’ recent seizure of ammunition destined for the Sudanese Armed Forces successfully removed “approximately five million rounds” of Goryunov-type ammunition from the supply chain, as noted in a report by Emirates News Agency. Ultimately, the responsibility for restricting the flow of arms requires more than just a national effort, but a global tripartite structure, similar to that of the KP.

The illegal arms trade is not peripheral criminal activity but a central driver of global instability and human suffering. A concerted and coordinated global effort is urgently required to address this unseen scourge”

Consequently, and in the spirit of the KP’s Year of Best Practice, collaborations with entities including the United Nations-bound Arms Trade Treaty and the United Nations Register of Conventional Arms could represent a positive first step toward a more proactive, structured approach, particularly in achieving common goals. As an additional step, both entities could also consider adopting the KP’s tried and tested structure, including a unified approach that provides higher standards of monitoring, implementation and enforcement, as well as an institutional bridge to create a parallel dialogue on corporate accountability within the arms sector. In doing so, there is a unique opportunity to illustrate the negative impact small arms have on diamond-producing countries while holding the world’s arms exporters to account.

Beyond collaborating with global organizations such as the United Nations, the international community must recognize the illegal arms trade not as a peripheral criminal activity but as a central driver of global instability and human suffering. A concerted and coordinated global effort is urgently required to address this unseen scourge and should start by enhancing levels of international cooperation.

As an industry that has been grossly unregulated, particularly when benchmarked against commodities such as diamonds, it is time to bring the arms trade out of the shadows and into the light of global scrutiny. Accountability and decisive action will be required to reform our collective criminal justice systems and drive meaningful change toward reducing and eventually eliminating some of the world’s most egregious criminal practices.

Paedophile hunter jailed for racist abuse at demo

15 August 2024 Share Save Oli Constable BBC News Reporting from Leeds Crown Court Share Save

West Yorkshire Police Phil Hoban had founded a group which snared suspected paedophiles

A self-styled paedophile hunter has been jailed after admitting racially abusing pro-Palestinian demonstrators in Leeds. Phil Hoban was a prominent figure in an anti-immigration protest in the centre of Leeds on 3 August, where he could be seen shouting and chanting. In a statement to Leeds Crown Court on Thursday, the 48-year-old said he was not racist and had stepped down from the Predator Exposure group he had founded which had “really gutted me”. He was jailed for eight months, having previously pleaded guilty to causing racially aggravated harassment, alarm or distress.

Hoban claimed to have snared 440 “online predators” using his social media channels, which he described as “child protection” work. One of the people who was caught in a sting operation from the group was Irish TV producer Kieran Creaven, who was jailed at the same court. Hoban told the court he had worked with police on a number of occasions in that role.

Hoban had been at the front of a group who were chanting

The father-of-three had been filmed by police at the demonstration outside the art gallery in the city centre. The non-violent event coincided with disorder in other towns and cities, including Sunderland and Southport. Climbing on a barrier, Hoban was pictured “rubbing your lips towards a person of colour”, said the Recorder of Leeds, Judge Guy Kearl KC. Hoban, of Northcote Crescent in Leeds, was then said to have imitated the manner in which Muslim people pray, in “order to mock their religion”, Judge Kearl added. The court was told Hoban had been making slurs referencing Allah. He denied this in a police interview, instead saying he was chanting about a man called “Alan”. The judge said his “conduct and that of your group was designed to stir up hatred”.

West Yorkshire Police James Gettings was jailed at Leeds Crown Court

James Gettings, 35, was jailed for eight months at Leeds Crown Court alongside Hoban. He was part of the same anti-immigration demonstration and video of him mocking Muslim people praying was shown to Judge Kearl on Thursday. Gettings, of Landseer Walk in Bramley, admitted causing religiously aggravated harassment, alarm or distress at a previous hearing. Carmel Pearson, prosecuting, said the defendant told police after he was arrested that he was “disgusted” by his own behaviour, he had been disowned by members of his family and that “three seconds of madness has ruined his life”. Listen to highlights from West Yorkshire on BBC Sounds, catch up with the latest episode of Look North or tell us a story you think we should be covering here.

LONDON (AP) — Lawyers have cited fake cases generated by artificial intelligence in court proceedings in England, a judge has said — warning that attorneys could be prosecuted if they don’t check the accuracy of their research.

High Court justice Victoria Sharp said the misuse of AI has “serious implications for the administration of justice and public confidence in the justice system.”

In the latest example of how judicial systems around the world are grappling with how to handle the increasing presence of artificial intelligence in court, Sharp and fellow judge Jeremy Johnson chastised lawyers in two recent cases in a ruling on Friday.

They were asked to rule after lower court judges raised concerns about “suspected use by lawyers of generative artificial intelligence tools to produce written legal arguments or witness statements which are not then checked,” leading to false information being put before the court.

In a ruling written by Sharp, the judges said that in a 90 million pound ($120 million) lawsuit over an alleged breach of a financing agreement involving the Qatar National Bank, a lawyer cited 18 cases that did not exist.

The client in the case, Hamad Al-Haroun, apologized for unintentionally misleading the court with false information produced by publicly available AI tools, and said he was responsible, rather than his solicitor Abid Hussain.

But Sharp said it was “extraordinary that the lawyer was relying on the client for the accuracy of their legal research, rather than the other way around.”

In the other incident, a lawyer cited five fake cases in a tenant’s housing claim against the London Borough of Haringey. Barrister Sarah Forey denied using AI, but Sharp said she had “not provided to the court a coherent explanation for what happened.”

The judges referred the lawyers in both cases to their professional regulators, but did not take more serious action.

Sharp said providing false material as if it were genuine could be considered contempt of court or, in the “most egregious cases,” perverting the course of justice, which carries a maximum sentence of life in prison.

She said in the judgment that AI is a “powerful technology” and a “useful tool” for the law.

When the EU pharmaceutical legislation review was published in 2023, EU Commission Vice President Margaritis Schinas noted that this is the most complex package the EU Commission has prepared for health during its mandate. “We are aiming to bring about a holistic, balanced review that’s fit for purpose, modern and reflects all the lessons drawn from the pandemic and the more complex world in which we live”.[i] Isn’t it striking that one of the most dynamic industries is still regulated by one of the oldest pieces of legislation? Just think of all the medical advances going through an EU regulatory framework written 20 years ago. That’s why Stella Kyriakides, the European commissioner for food and health safety, set out her stall: “We are aiming to build a simpler, faster regulatory ecosystem. This will mean without compromising safety, we can reduce assessment times for medicines from around 400 days to 180.”i

The regulatory framework has untapped potential to boost the EU’s attractiveness for investing in pharmaceutical research and development (R&D) for the benefit of patients. Moreover, the recent Draghi report on the future of European competitiveness concludes that innovation in the EU pharmaceutical sector is hindered by a slow and complex regulatory framework.[ii] Yet, arguably, the regulatory content has received much less attention during the EU parliamentary discussions. Now, when member states are in mid-negotiations, it’s important to have a clear understanding of what is at stake for competitiveness. There is a risk this becomes a missed opportunity to future-proof the regulatory framework as an innovation enabler, keeping pace with the latest scientific and technological developments that benefit patients.

There is a risk this becomes a missed opportunity to future-proof the regulatory framework as an innovation enabler, keeping pace with the latest scientific and technological developments that benefit patients.

In the context of an ever-evolving geopolitical and economic landscape, the attention of policymakers is shifting back to strengthening competitiveness. The EU Commission’s Political Guidance for the new mandate[iii] clearly shows that EU Commission President Ursula von der Leyen is positive the EU life science sector must be at the heart of initiatives to boost industrial competitiveness. Without a competitive regulatory framework, Europe, which is already competitively falling behind other regions globally (25% reduction in global R&D investment over the last 20 years), risks slowing down patient access to innovative medicines.[iv]

Currently, the EU regulator, the European Medicines Agency (EMA), offers expedited pathways, such as the Priority Medicines Scheme (PRIME)[v] and Accelerated Assessment.[vi] These pathways streamline regulatory development and assessment of innovative new medicines and provide regulatory support to pharmaceutical companies and other developers – depending on the potential to address unmet medical needs. They can speed up patients’ access to new treatments – for instance, for orphan diseases impacting very few patients or cancers where no treatment is currently available.

However, the EU regulator uses expedited pathways far less often than other regions. Between 2019 and 2023, the EMA approved 8% of new active substances via expedited reviews, compared with 71% in the United States, 45% in Japan, 18% in Canada and 13% in Switzerland.[vii] Hence, a patient in the EU would get slower access to new medicines addressing an unmet medical need compared with patients in other regions.

via Johnson & Johnson

While the EU intends to revise the PRIME framework,[viii] it is uncertain if new indications (a condition beyond the initial condition the medicine was approved for) addressing unmet medical needs are also in its scope. These should be explicitly included so patients with these conditions have the possibility for earlier access.

The EU is defining an ‘unmet medical need’,vii also a key eligibility criterion for PRIME.vii It’s important that its definition is not too restrictive, reflects what matters most to patients and includes improvements to quality of life. At Johnson & Johnson, we believe the value of medicines should not be determined purely by the presence of a condition or ability to survive it, but it should also factor in how medicines may improve the quality of patients’ daily lives. Patients should be able to live the best lives they can with the conditions that they have. If the definition of unmet medical needs does not consider the quality of life of patients as a parameter, the EU will not see more treatments becoming eligible for PRIME, accelerated assessment or conditional approval compared with the current situation. Europe cannot afford to miss this opportunity to remain globally attractive and competitive and help bring medicines more swiftly to patients.

At Johnson & Johnson, we believe the value of medicines should not be determined purely by the presence of a condition or ability to survive it, but it should also factor in how medicines may improve the quality of patients’ daily lives.

As part of the revision, the EU Commission proposes to amend the Paediatric Investigation Plan (a development plan ensuring that the necessary data are obtained through studies in children to support the authorization of a medicine for children). The amendment would mean that where an adult condition being researched doesn’t affect children, developers will need to do research in other conditions in that disease area where the medicine might work based on its mechanism of action.[ix] For example, a medicine for Alzheimer’s will need to be researched in one or more childhood neurological conditions. This Mechanism of Action Paediatric Investigation Plan should be underpinned by a robust, science-based framework to ensure meaningful outcomes for children. Focus should be placed on areas of most unmet medical need rather than mandating unlimited clinical studies.Since this approach is more complex and lengthier than the current one, the reward of patent protection should be extended from 6vii months to 12 months.

Another proposal that might undermine EU regulatory competitiveness relates to product information on medicines made available to physicians and patients. Currently, Marketing Authorisation Holders (MAHs) are required to update this information when new evidence of efficacy or safety is generated.[x] However, the draft legislative proposal allows the EMA to update efficacy as well as safety information without consulting MAHs.vii Similarly, draft rules on repurposing already authorized medicines exclude MAHs from decisions on whether products should be approved for new conditions based on requests from non-profit third parties.vii These changes could result in a requirement for the MAH to develop and market for new groups of patients and new conditions. However, to make such changes, developers must have access to specialist expertise for the new conditions, especially so they can manage safety-related issues that may arise. It also means the MAH is liable for use that it may not endorse. We believe MAHs should remain fully responsible for their medicines and retain the right not to be compelled to market in additional indications/groups of patients.

With the rapid and wide-ranging advances in digital health, artificial intelligence and precision medicines, the revision of the pharmaceutical legislation is a once-in-a-generation opportunity to build a future-proof regulatory system that truly supports patient needs and the timely adoption of medical innovation. Let’s fully realize its potential to help the EU become more competitive and ensure that the EMA doesn’t lag other regions in approval times for medicines.

CP-475428 Date of preparation Sept 2024

[i] Opening remarks by VP Schinas & Commissioner Kyriakides on the revision of the EU’s pharmaceutical legislation. Available at https://ec.europa.eu/commission/presscorner/detail/en/speech_23_2465 Last Access Sept ‘24

[ii] The Future of European Compeitiveness report. Available at https://commission.europa.eu/document/download/97e481fd-2dc3-412d-be4c-f152a8232961_en?filename=The%20future%20of%20European%20competitiveness%20_%20A%20competitiveness%20strategy%20for%20Europe.pdf Last accessed Sept ‘24

[iii] Political Guidelines for the next European Commission 2024-29:. Available at https://commission.europa.eu/document/download/e6cd4328-673c-4e7a-8683-f63ffb2cf648_en?filename=Political%20Guidelines%202024-2029_EN.pdf Last accessed Sept ‘24

[iv] EFPIA News. Available at https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/research-based-pharmaceutical-industry-calls-on-european-commission-to-develop-comprehensive-health-and-life-science-strategy/ Last accessed Sept ‘24

[v] EMA PRIME Available at: https://www.ema.europa.eu/en/human-regulatory-overview/research-development/prime-priority-medicines Last accessed Sept 24

[vi] EMA Accelerated Assessment Available at: https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/accelerated-assessment Last accessed Sept ‘24

[vii] CIRS RD Briefing: New drug approvals in six major authorities 2014-2023: Changing regulatory landscape and facilitated regulatory pathways Available at https://cirsci.org/wp-content/uploads/dlm_uploads/2024/07/CIRS-RD-Briefing-93-six-agency-briefing-v2.0.pdf Last Accessed Sept ‘24

[viii] Proposal for a Regulation Of The European Parliament And Of The Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, Available at: https://eur-lex.europa.eu/resource.html?uri=cellar:e3f40e76-e437-11ed-a05c-01aa75ed71a1.0001.02/DOC_1&format=PDF Last accessed Sept ‘24

[ix] Proposal for a Directive of the European Parliament and Council https://eur-lex.europa.eu/resource.html?uri=cellar:bfcb9e00-e437-11ed-a05c-01aa75ed71a1.0001.02/DOC_1&format=PDF Last accessed Sept ‘24

[x] EMA How to prepare & review a summary of product characteristics. Available at https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/product-information-requirements/how-prepare-review-summary-product-characteristics. Last accessed Sept ‘24

“There are serious implications for the administration of justice … if artificial intelligence is misused,” said Victoria Sharp, president of the King’s Bench Division of the High Court in London. | Andy Rain/EFE via EPA

The warning comes after so-called hallucinations — AI-generated fictions — have cropped up at big law firms.

In a stern intervention, a judge at the High Court of England and Wales issued a formal warning to legal professionals on Friday, declaring that lawyers who submit fictitious cases generated by artificial intelligence could face criminal charges.

The senior judge scolded lawyers in two cases who apparently used AI tools when preparing written arguments that were presented in court.

“There are serious implications for the administration of justice and public confidence in the justice system if artificial intelligence is misused,” Victoria Sharp, president of the King’s Bench Division of the High Court, said in the judgment delivered on Friday.