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Getting safe cancer drugs to children

December 22nd, 2017
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Rating: 4.2/5 (5 votes cast)

The Daily Mail print edition today (22 December) runs a piece headlined “Children denied cancer drugs due to EU delays.”

There is no doubt that the issue of extending drug trials to children is a real one and that campaigners have written to Commission President Jean-Claude Juncker urging further strengthening of EU rules requiring drug companies to extend trials to children. The Commission is, of course, continuously listening to stakeholders and is determined to do everything possible to help give patients access to safe and effective drugs.

The Daily Mail is quite right to pay attention to this matter and to report the views of campaigners, so this is not a typical Euromyth entry refuting entirely or largely untrue and misleading stories.

However, the Mail does not make clear that these EU rules are already the strongest in the world and have led to significant improvements compared to the previous situation. Neither does the piece illustrate that this is a complex medical, ethical and practical issue with no easy solution. Just to highlight one of those aspects, as one reader responds to the Mail Online: “Imagine if a child died as a result of a clinical trials…”

As the Mail does, to its credit, recognise, this is a cross-border and global issue, and the UK will, like any other single country, not be in a position post-Brexit to compel drug companies to act differently, simply by acting alone.

Here is a statement we sent to the newspaper, now partially reflected in the online piece.

“EU rules certainly do not prevent pharmaceutical companies from carrying out research into using new drugs to treat children. The rules require companies to do so unless they can justify otherwise. This has been a major factor in the recent increase in the number of new medicines being authorised for children: 260 have been given the go-ahead in the last ten years.

This is a highly complex area, where regulators – not just in the EU, where rules are already stronger than other jurisdictions – must proceed with caution in order to maximise the availability of drugs for children while avoiding harming patients, discouraging research, or inducing companies to move it to other jurisdictions where there are fewer requirements.

Together with the European Medicines Agency (EMA), the Commission is acting to streamline how the Paediatric Regulation works. This includes analysing the use of deferrals, looking at ways to ensure speedier completion of PIPs, reviewing guidelines for handling PIP applications and stepping up efforts to foster international cooperation and harmonisation of rules. Together with the EMA, the Commission intends to bring together all stakeholders, including patients’ organisations, to establish an open and transparent dialogue on paediatric needs.

Before proposing regulatory changes to further improve the situation – those would need to be agreed by Member States and the European Parliament – the Commission needs to further scrutinise, along with regulators and stakeholders, how best to combine the effects of the Paediatric Regulation with the Orphans Regulation (covering rare diseases) in order to benefit as many patients as possible.

Background

The EU Paediatric Regulation came into force in 2007 – it was the first ever in the world to force companies to engage in a specific type of medical research. The Commission’s report on the ten years of implementing the Regulation shows that over 260 new medicines for use with children have been authorised. Over 1000 Paediatric Investigation Plans (PIPs) – the first step in developing medicines for children – have been agreed. There is a clear upward trend in the number of completed PIPs.

PIPs may be waived under specific circumstances to avoid unnecessary, or even unethical research.  For example, if a treatment is likely to be ineffective or unsafe or will not provide a significant therapeutic benefit over other existing treatments.

The European Medicines Agency reviewed the waiver decision in 2015 and limited its scope, so those companies that want a waiver must justify it to the Paediatric Committee.  This forces companies to contact the committee at an early stage of development, to discuss the paediatric potential and seek certainty about requirements.  The three year transitional period is not over so the effects of the class waiver review cannot yet be adequately evaluated.

The Commission report recognises that the least progress is indeed being made in diseases that are biologically different in adults and children, or which only affect children. This is often the case with rare diseases, including childhood cancers.

Complementing the Paediatric Regulation, “Orphans” legislation aims to increase the treatment options available for rare diseases, including rare cancers in children. It sets out other incentives such as a 10 year market exclusivity or fee waivers for the regulatory procedure.”

This issue has been covered previously on this site here.

Myths and chips

December 19th, 2017
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Rating: 4.4/5 (8 votes cast)

World-renowned scientists – and not “barmy EU chiefs”, as The Sun has it – have produced a report for the European Commission on how the oceans, notably through acquaculture, can produce more food, more sustainably.

This is a crucial global challenge, with the world’s population forecast to reach a possible 10 billion by 2050.

The report does, as The Sun says, recommend among other things producing more mussels, oysters, cockles, clams and – yes – seaweed, all of which have of course been eaten in the UK for a long time.

It does not say people should stop eating fish and chips. Indeed, its recommendations aim to allow for the sustainable production of more, not less, of the types of fish that Brits and many others enjoy eating with chips.

These are recommendations by a group of eminent scientists, including Sir Paul Nurse of London’s Francis Crick Institute.

Any EU policy changes would, as usual, need to be proposed by the European Commission and approved, after amendment, by elected members of the European Parliament and by ministers from national governments.

Sun readers can be reassured: despite the codswallop, many “EU bureaucrats” themselves, “barmy” or not, enjoy fish and chips (and mushy peas, which the British press accused the EU of banning back in 1995, but which are miraculously still with us). They – we – want everyone else to carry on doing so, too.

Oh, and cod is still called cod as well despite these media stories from 2001 claiming it would have to be sold in the chippie by its Latin name.

EU is acting on scientific evidence to cut lead in toys, not stopping children colouring

January 29th, 2017
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Rating: 3.7/5 (58 votes cast)

The EU is introducing new measures reducing the limits for lead in toys, based on new and robust scientific evidence.

Anyone with young children knows that they have tendency to chew toys – not least pencils and crayons. The latest scientific evidence supports the view that there is no safe threshold and even tiny amounts of lead present in such toys can contribute to the risk of children suffering disorders ranging from kidney disease to learning difficulties.

So this is about making toys safer for children, not about “banning” crayons and colouring pencils as The Sun newspaper suggests. Read the full entry

EU moves to end impunity for dangerous drivers but some media speed to wrong conclusion

January 27th, 2017
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Rating: 3.5/5 (30 votes cast)

New EU rules adopted by national ministers and the European Parliament mean people can no longer easily avoid paying fines imposed on them for driving dangerously in other EU member states than their own. This EU framework applies to all member states equally. There is no “quirk of EU law” discriminating in some way against British drivers as some UK media claim. If the UK authorities choose not to pursue non-resident offenders, that is up to them. Neither are there any “EU-imposed fines” (The Times) or “hefty EU speeding fines” (Daily Express). Each member state is in full control of its traffic rules and levels of fines or other sanctions.

Read the full entry

Ceiling flaw in suggestion EU rules behind payments to big landowners

September 29th, 2016
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Rating: 3.3/5 (41 votes cast)

Stories today based on a Greenpeace report about EU Common Agricultural Policy (CAP) subsidies to large landowners cover a matter which has been widely debated over many years and are mostly accurate, as far as they go. But not all of them give quite the full picture.

EU rules allow Member States to cut substantially so-called “basic payments” under the CAP to large landowners, such as most of those cited in the Greenpeace report, by applying an upper limit (ceiling). Nine Member States do so.

In the UK, such a ceiling is applied in Northern Ireland, Scotland and Wales – with the resulting funds generated remaining in those regions for rural development projects.

The UK chooses not to apply a ceiling in England.

The European Commission’s repeated proposals for more radical reform have been watered down by national Ministers.

Only active farms are eligible for CAP funding as long as the farmer keeps his land in a state suitable for agricultural production. The business of breeding racehorses is not supported, though the land on which horses graze might qualify if it meets the criteria.

Basic payments account for in the UK and most Member States for around 70% of all CAP payments made to farmers.

Further info

In 2010, the European Commission proposed extensive reforms to the CAP, including to place a compulsory ceiling on payments to large landowners under the CAP’s basic payment scheme, thus putting an end to payments at the levels referred to in today’s reports.

A number of Member States combined to oppose these proposals.

As no EU law can be adopted without approval from both Member States and MEPs, this meant the extensive reform package implemented from 2014 did not include any compulsory ceilings, only a reduction of 5% on all amounts over €150 000.

However, an option was left open for individual Member States to apply a ceiling at national level.

Similar proposals to limit the amount of payment per individual farm were made by the Commission in successive CAP reform exercises since 1992 – but were always blocked by Member States.

In the UK, ceilings are now applied in Northern Ireland (€150 000), Wales (€300 000) and Scotland (€600 000). Read the full entry

EU doctors in UK are not “a threat to patients” as Daily Mail says. If they left, that WOULD put patients in danger

September 24th, 2016
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Rating: 4.4/5 (49 votes cast)

It is out of the question that EU rules would require the UK to let linguistically or medically incompetent doctors practise. In fact, the rules – recently further reinforced in agreement with the UK – expressly require Member States to prevent such people from being employed.

Yet, the Daily Mail runs yet another misleading front page article on 24 September headlined “Patients at risk from EU doctors” and alleging that “thousands of EU doctors can work in the UK without basic safety checks.” Online, the headline becomes an even greater insult to about 30 000 “EU doctors” – 10% of the total – working in the NHS: “Patients ARE at risk from thousands of EU medics.”

The consensus in the profession – as has been reported by several other newspapers, including the Times here – is that the threat to patients comes from “EU doctors” deciding to leave the UK rather than staying here to save lives and cure illness. So, while clearly patient safety should always be the top priority for healthcare organisations, it is hard to see how national newspaper front pages and online pieces impugning European doctors’ professionalism will help patients.

This is a point made in no uncertain terms in response to the Mail article by some stakeholders and medical professionals on social media.

Again, the Mail chose not to contact us for comment before its latest splash.

We have provided details of how EU rules work, here and here. We will not repeat those in this piece.

There are, however, some important elements to add.

Read the full entry

Sun’s imperial “up yours” to Brussels falls down on the facts

September 1st, 2016
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Rating: 4.5/5 (167 votes cast)

The Sun runs an article on 31 August by Bill Cash MP claiming the EU has banned the use of pounds and ounces. The paper follows up by suggesting ten ways to “say up yours to the EU.” This may be intended as humour. But it repeats inaccuracies and misleading statements which seem to be widely believed and therefore are worth correcting yet again.

First, the EU has never banned pounds and ounces or other imperial measures. EU law does require metric measurements to be used – though already in 1965, eight years before joining the EEC, the Wilson Government decided to initiate the UK’s metrication programme, in response to global moves in this direction. However, EU law has always allowed imperial measures to be used alongside metric ones – as the Sun itself acknowledged at the bottom of this earlier article. Visiting any supermarket or market stall is enough to confirm this. This issue has been addressed on this blog several times, for example here, back in 2001.

The Sun proposes “having cleaner carpets by swapping weak, EU regulated vacuums for powerful ones”.   In fact, consumer magazine “Which” has found that new EU rules – backed by Member States, industry and consumer groups – on the specifications for vacuum cleaners (the facts here) have led to better performance and cheaper running costs. In any case it is uncertain that vacuum cleaner manufacturers, who operate globally, would want to produce models generally considered obsolete just for UK markets.

There are no proposals on the table to introduce similar rules for hair dryers, toasters or other appliances not already covered, as referred to in two of the Sun’s helpful suggestions for saying “up yours” to the EU and as we explain here. Only if there is cast-iron scientific evidence will the Commission put forward such proposals, and in any case they would need to be agreed by Member States and the European Parliament. If such evidence were clearly established, it would remain to be seen whether the UK parliament or public – inside or outside the EU – would wish to create unnecessary pollution, environmental damage and higher electricity bills by insisting on energy guzzling appliances, even in the event that manufacturers did want to keep producing them.

Another suggestion the Sun puts forward is bringing back old-fashioned incandescent light bulbs that require changing more often and thus cost consumers more. The Sun is correct that incandescent light bulbs have been phased out in the EU, not on the basis of a high-handed bureaucratic decision but as a result of a clear mandate from elected ministers and MEPs. They have been, or are being, phased out also in the US, Canada, Switzerland, China, Australia, Brazil, Russia and many other jurisdictions. Again, we have covered this issue in earlier entries and again there does not so far seem to be any evidence that the UK – which supported the EU measures – would now want to go against this global trend.

The Sun also calls for the UK to “reclaim jam” from EU rules that stipulate it should have 60% sugar content. But the rules already allow flexibility on this. What is more, the British media – including the Sun – have previously complained about this very flexibility, saying it would “ruin British jam”! This saga is explained here.

There are no EU rules preventing the recycling of tea bags. Again this is a very old – and wrong – story. Read the full entry

Express wrong to call green cars “waste” and wrong to suggest EU is prioritising them above terrorism

July 27th, 2016
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Rating: 4.2/5 (25 votes cast)

The Daily Express complains that the latest EU Horizon 2020 research and innovation work programme includes £112 million for electric cars. Electric cars can make an important contribution to cutting air pollution, which is estimated to cause 400 000 premature deaths in Europe every year.

So asserting that investing money in this area is “splurging members’ cash on waste” is, to put it mildly, ill-informed.

The Express compares funding for high-tech industrial research with “just £41m spent researching terrorism” and uses this to suggest to readers that the EU is somehow neglecting to take action on terrorism. This is a false comparison and a cynical and misleading conclusion to draw from it.

Read the full entry

Medical devices: Daily Mail misrepresents EU system and fails to mention reforms

July 4th, 2016
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Rating: 4.2/5 (52 votes cast)

An article on medical devices – such as implants and artificial hips – published in Daily Mail on 29 June contains serious inaccuracies and leaves out crucial points. In particular, it misrepresents the current system for the approval of such devices and neglects to point out that the EU has taken a series of important steps to strengthen that system.

Background

According to the article, “Brussels” and the European Commission approve unsafe high-risk medical devices on the EU market.

This is not the case.

Under EU legislation, independent third-party organisations (Notified Bodies) check and scrutinise medical devices before their CE certification and possible placing on the market. These Notified Bodies are designated and monitored by national authorities, not by “Brussels”.

Read the full entry

Express’s “EU £2600 tax bombshell” story completely wrong

June 20th, 2016
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Rating: 4.5/5 (60 votes cast)

Changes to EU VAT rules require a unanimous agreement by all Member States. That is written in black and white in the EU Treaties, which set out and limit the powers the EU has – and also make very clear that the final say on all big political decisions rests with elected ministers and MEPs, not “Brussels” or “faceless bureaucrats”.

The Treaties themselves are drawn up by – and can only be changed by – unanimous agreement of the Member States.

In other words the UK has a veto both on any changes to VAT rules AND on any changes to the way the EU takes decisions in that area.

So despite the various fulminations quoted in the article, the suggestion in the Daily Express on 20 June that “Brussels” could force the UK to raise VAT rates and cause “a £2600 tax bombshell” is completely factually wrong.

Where there IS agreement that the rules will change is that the possibility to zero rate sanitary products will be introduced- EU leaders made that clear at their summit on 17-18 March.

The rationale for having such VAT rules – agreed by all Member States – is that rates that differed too widely within the single market would increase red tape and costs for business and mean consumers paying more for goods and services.

EC in the UK

Check the EC Representation in the UK website

Please note that all statements in all entries were correct on the date of publication given. However, older archived posts are not systematically updated in the light of later developments, for example changes to EU law.

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