Tuesday

6th Jun 2023

Media lift lid on secret reports on drug side-effects

  • The industry says documents of this type are easily misunderstood and misinterpreted. (Photo: www.freeimages.co.uk)

Adverse reactions to medication is the fifth most common cause of death in hospitals according to the European Commission, but EU agencies and national governments have until now kept secret pharmaceutical companies' reports on side-effects.

The notes - known in the business as Periodic Safety Update Reports (PSURs) - are submitted regularly to national authorities and the European Medicines Agency in London.

Read and decide

Join EUobserver today

Become an expert on Europe

Get instant access to all articles — and 20 years of archives. 14-day free trial.

... or subscribe as a group

The PSURs for example detail how doctors in various countries suspect that teenagers grow suicidal when taking a certain medication against pimples, or that a diet product could lead to a stroke and what industry has to say about the medical fears.

A team of Dutch, Danish and Belgian journalists has now used freedom of information legislation in the Netherlands and Denmark to get partial access to the documents, where patient gender, age and country of origin are blacked out to protect privacy and business interests. A legal decision is pending in Belgium.

The move by Dutch daily newspaper Trouw, Belgian magazine Knack in cooperation with Danish magazine Samvirke to put the documents on the internet comes as the European Commission on Tuesday (22 October) decided to delay the publication of a new package of regulation for drugs producers.

The commission package is not expected to mandate publication of PSURs but is likely to allow pharmaceutical companies to contact patients directly - a practice that is currently illegal and was condemned by the European Parliament in 2002.

"In my view, there can be no doubt that PSURs should be made public. After all this is about the side-effects on medicines that we take," Margrethe Nielsen, a researcher at the Cochrane Institute's Copenhagen branch and a specialist on pharmaceuticals told EUobserver.

She added that the notes, which form the basis of government understanding of the sector, are not based on clinically controlled tests method. "This is maybe the most important: this does not build on sound science," she said. "I would not be able to use them for my work."

"In these reports [released in the Netherlands and Denmark] much too much has been blackened. The quality is unequal. It is of big importance that these safety reports can be accessible for everybody so that scientists can debate about their quality," Canadian expert Barbara Mintzes told Knack.

Reacting in a test case on PSUR publication in Denmark in 2007, lawyers for drug firm Roche threatened to sue the Danish state if disclosure harmed the company's commercial interests.

"A competitor can use the reports as a basis for guidance to patients and guidance to doctors. Competitors can with the help of PSUR reports obtain a basis to take care of guiding functions, that can weaken Roches position on the market and thus bring significant negative economic effects for Roche worldwide," the company's legal advisors wrote in letters to Danish authorities.

"Experience shows, that documents of this type are easily misunderstood and misinterpreted, for example by journalists," the letters add. "Misunderstandings of this type can cause severe disturbance of the market and thus loss for Roche."

The view is shared by the Brussels-based trade lobby, the European Federation of Pharmaceutical Industries and Associations (EFPIA), today.

"The trouble is, they have to be understandable. You need to be an expert, to understand them. I would push that back to the regulator to take proper action. When you pull information, it has to be in a form, that you and I can understand," EFPIA director Brian Ager said.

"The industry claims that the people wouldn't understand them. In reality making the side effects public would influence the stock exchange in a negative way," French medical journal Prescire's editor Bruno Toussaint said.

Opinion

How the EU's money for waste went to waste in Lebanon

The EU led support for the waste management crisis in Lebanon, spending around €89m between 2004-2017, with at least €30m spent on 16 solid-waste management facilities. However, it failed to deliver.

Latest News

  1. Final steps for EU's due diligence on supply chains law
  2. Top EU court rules Poland's court reforms 'infringe law'
  3. Sweden's far-right is most anti-Green Deal party in EU
  4. Strengthening recovery, resilience and democracy in regions, cities and villages
  5. Why Hungary cannot be permitted to hold EU presidency
  6. Subcontracting rules allow firms to bypass EU labour rights
  7. Asylum and SLAPP positions in focus This WEEK
  8. Spanish PM to delay EU presidency speech due to snap election

Stakeholders' Highlights

  1. International Sustainable Finance CentreJoin CEE Sustainable Finance Summit, 15 – 19 May 2023, high-level event for finance & business
  2. ICLEISeven actionable measures to make food procurement in Europe more sustainable
  3. World BankWorld Bank Report Highlights Role of Human Development for a Successful Green Transition in Europe
  4. Nordic Council of MinistersNordic summit to step up the fight against food loss and waste
  5. Nordic Council of MinistersThink-tank: Strengthen co-operation around tech giants’ influence in the Nordics
  6. EFBWWEFBWW calls for the EC to stop exploitation in subcontracting chains

Stakeholders' Highlights

  1. InformaConnecting Expert Industry-Leaders, Top Suppliers, and Inquiring Buyers all in one space - visit Battery Show Europe.
  2. EFBWWEFBWW and FIEC do not agree to any exemptions to mandatory prior notifications in construction
  3. Nordic Council of MinistersNordic and Baltic ways to prevent gender-based violence
  4. Nordic Council of MinistersCSW67: Economic gender equality now! Nordic ways to close the pension gap
  5. Nordic Council of MinistersCSW67: Pushing back the push-back - Nordic solutions to online gender-based violence
  6. Nordic Council of MinistersCSW67: The Nordics are ready to push for gender equality

Join EUobserver

Support quality EU news

Join us