Press review

 - 

Companies to face fines in France for mismanaging drug shortages

Country : France, Italy, Switzerland, U.S., UK

Keywords :
PARIS, 20 Sep (APM) - France's prime minister Edouard Phillipe announced to pharma companies, pharma body Leem and patient associations on Thursday that companies will face fines if they do not fulfil their obligations regarding drug shortages, reports Les Echos on Friday (p.15).
The measure laid out in the 2020 social security funding bill (PLFSS) could see pharma companies fined a maximum of 30% of their average daily sales in France for every day of the shortage. In all, they could be fined up to 10% of their annual sales, or €1 million.
Following the measure, pharma companies will have to ensure they have two to four months stock of drugs of major therapeutic interest at hand. They will be fined if they do not warn France's drugs regulator ANSM far enough in advance that they are going to stop marketing a drug, or if they have not prepared an alternative. In the latter's case, they will have to pay the cost of the replacement. Fines will also be given if a company's shortage management plan fails.
Drug shortages have often been in the news in France, with ANSM stating that the number of shortages declared in the country has increased from 44 to 2008 to 868 in 2018. Outsourcing drug production to subcontractors in countries where quality controls are not as strict as in Europe as been held responsible for the increase, as has the Chinese demand for vaccines.

Pharma pay more tax in France than in neighbouring countries

A PwC study commissioned by French pharma body Leem has shown that French pharma pay more tax than pharma companies based in neighbouring European countries, reported Les Echos on Monday (p.19) (APMHE 64391).
Not only do French pharma pay more, but the gap between how much they pay and how much fellow pharma pay is growing, according to the report the amount of sector tax paid in France has increased by 4% between 2016 and 2019.
One reason for this, the paper continued, is that other European countries, including the UK, Italy and Switzerland, have carried out financial reforms which have significantly reduced pharma company taxes. France announced it would also cut taxes for pharma companies, but these cuts have been pushed back to 2020.
French pharma pay several different taxes: the traditional business taxes, but also sector taxes, taxes on the sales of reimbursed drugs, on the promotion and sales direct to community pharmacies, as well as taxes for the management of marketing authorisations and those paid to fund the bodies which recycle drug packaging and unused drugs.

French drugs' regulator shuts down illegal clinical trial

France's drugs' regulator ANSM has shut down an illegal clinical trial testing melatonin patches on at least 350 patients with diseases such as Alzheimer's and Parkinson's, reports Le Parisien on Friday (p.9).
The trial was being carried out by Fonds Josef, whose vice-chair is controversial professor Henri Joyeux, known for his anti-vax stance. ANSM told the paper that it is for the French justice system to decide whether he will face charges.
Le Figaro also reports on the story on Friday (p.11) stating that according to ANSM, the trial had not been authorised, with substances whose quality, effects and tolerance are unknown. It added that there could very well be a risk to patients' health.
Liberation also reports on the story in a brief on Friday (p.16).

Sackler family accused of moving money to Switzerland

The Sackler family, owners of Purdue Pharma, which is at the heart of the opioid crisis in the U.S., have been accused of trying to conceal the extent of its fortune, reported Le Monde in a brief on Monday (p.14).
According to New York's attorney general Letitia James, the family has transferred $1 billion to Switzerland.

Purdue Pharma declares bankruptcy

Purdue Pharma, at the heart of the opioid crisis in the U.S., has declared itself bankrupt and will be placed in a trust overseen by a board on behalf of the U.S. States and towns who have filed charges against it, reported Les Echos on Tuesday (p.20) (APMHE 64368).
It is hoped that by doing so, Purdue Pharma can avoid the trial set to take place on 21 October.
In addition to placing the company under the control of a trust and using the $10 billion resulting from this move to pay out compensation, the pharma's subsidiary Mundipharma will be sold and the Sackler family, which owns Purdue, will contribute $3 billion of their own money to pay out compensation.
However, almost 25 U.S. states are still opposed to this proposal according to Bloomberg, the paper continued, and several of them are asking the Sackler family to increase their contribution to $4.5 billion.
La Croix (p.11), Libération (p.9) and Le Figaro (p.25) also reported on the story on Tuesday. Le Figaro also reports on the story on Friday (p.19-21).
hg/nh

[HG7PY4K61]

TRY APM HEALTH EUROPE AND GET ACCESS TO THE FULL CONTENT

Interviews with KOLs/senior executives amongst the Regulators, Payers, Health, Medical & Pharmaceutical organisations

Events coverage with a unique focus on Market Access & sustainability of healthcare systems

6 European bureaus : Berlin, Brussels, London, Madrid, Milan & Paris

Ask for a Free trial and get access to the latest stories

Our coverage includes:
  • Health Care
  • Market Access
  • HTA – policies & practices
  • European medicine regulations
  • Drug safety issues
  • Pricing & Reimbursement
  • International medicines agencies

If you are a Payer, Pharmaceutical or Consulting professional our premium data will keep you informed on the regulatory, pricing, market access and cost-effectiveness issues that impact all stakeholders.

REQUEST

an initial 10 day temporary access of APM Health Europe.