Press review

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France has 'advantages' but still lagging in giving drugs market access – Janssen head

PARIS, 12 July (APM) - Janssen France head Emmanuelle Quilès said France has 'advantages' notably in removing administrative barriers to attract young innovative companies but is still lagging other European countries in getting drugs to market.
Despite promises made at the French healthcare industry strategic council (Csis) meeting last July on reducing the length of time it takes a drug to get market access in France, Quilès said in an interview with L'Opinion published on Wednesday (p.8) that almost no progress has been made and that it still takes far too long.
She pointed out that in Germany, a drug is available as soon as it is approved, while in France the medicine must be evaluated and the price discussed, a process which can take more than 500 days.
However, she said that France has advantages and a lot of potential, particularly through President Emmanuel Macron's plan to make French ''a start-up nation''.
She also briefly mentioned the benefits artificial intelligence (AI) can have for pharma companies and the pharma industry. She mentioned that AI can help increase what we know about cancer through big data and predict how patients will react to certain drugs.

French health minister presents plan to combat drug shortages

France's health minister, Agnès Buzyn, presented a roadmap to combat drug shortages on Monday, Le Figaro reported on Monday (p.20).
The roadmap contains proposals from various stakeholders, including increasing information sharing along the manufacturing and delivery chain and increasing transparency. The roadmap also calls for more communication on a European scale to tackle the ever-growing problem. Community pharmacists will now also be able to saw a drug of major therapeutic interest (MTI) with another drug in the same category.
Buzyn is also calling for fiscal and financial incentives to encourage manufacturers to bring the factories that manufacture raw materials for drugs back to France and Europe, as that will cut the number of supply problems and alerts of stocks running out.
However, L'Humanité criticised the roadmap on Tuesday (p.13) saying it does not go far enough, with no mention of sanctions or fines for the pharma companies behind the shortages.
Almost one in four French people have felt the impact of a drug shortage and the number of stock shortages in the country increased 20-fold between 2008 and 2018.
La Croix (p.6), L'Opinion (p.3), Les Echos (p.1 and p.4) and Le Parisien (p.6) also reported on the topic on Tuesday. Le Monde Science & Médecine (p.3), Le Monde (p.28) and Le Canard Enchaine (p.4) all reported on the topic on Wednesday.

Rise of cell therapies

It will not be long until the miraculous recovery of a child with previously incurable leukaemia is nothing new due to the rise of CAR-T drugs, reported Les Echos on Monday (p.20).
Novartis and Gilead are already treating patients with their personalised, one-off treatments and Celgene is not far behind, benefiting from the mistakes made by the other two pharma.
But the economic daily asks about the size of the market share these drugs will have - given that demand fluctuates greatly, stocks cannot be built up and the price (Novartis' Kymriah (tisagenlecleucel) is priced at $475,000 and Gilead's Yescarta (axicabtagene ciloleucel) at $373,000.
On the whole, all the CAR-Ts currently available have the same target population which only has 700 patients a year. And the arrival of newer generation 'classic' drugs, such as Janssen's Darzalex (daratumumab) and Takeda's Ninlaro (ixazomib) are considerably increasing patient survival, at a lower price and with fewer adverse events than CAR-Ts.

France to delist homeopathy

Homeopathy will no longer be reimbursed in France as of 2021, Les Echos reported on Wednesday (p.2).
Homeopathic products will not be delisted immediately, the paper continued. They are currently reimbursed at 30% and this will fall to 15% before they are finally taken off the reimbursement lists completely as of 1 January 2021.
The French government has emphasised that the products will still be available, they just will no longer be reimbursed, following a study carried out by an independent body in August 2018 on the therapeutic efficacy of homeopathic products.
This decision has caused a debate in France, where the health insurance spent €127 million reimbursing homeopathy in 2017.
Boiron, a French homeopathic company, is protesting the decision and is threatening to cut 1,000 of the 2,500 jobs it has in France if homeopathy is taken off the reimbursement lists. Somme 67% of the group's sales come from France, a total of €360 million, with 70% of that, or €252 million, coming from social security reimbursement.
The topic was also covered on Wednesday by Le Parisien (p.1-3), Le Figaro (p.11), Le Canard Enchaine (p.2), on Thursday by Le Monde (p.1, p.10-11), Les Echos (p.1, p.12, p.14 and p.26), Le Figaro (p.20) and L'Humanité (p.10) and on Friday by Le Monde (p.26) and Les Echos (p.8).

New chair of French pharma body Leem

Frédéric Collet has been elected chair of French pharma body Leem, Le Figaro announced on Thursday (p.22). He is head of Novartis France and has been on Leem's board since 2013. (APMHE 63651)
When the previous Leem chair, Philippe Tcheng had to stand down in February because of ill health, Collet took up the position of acting chair. Les Echos also reported on his appointment on Thursday (p.23).

Potential closure of French Famar factory could lead to drug shortages

The French factory of Greek manufacturer Famar near Lyon risks closure, after going into receivership on 24 June, reports L'Humanité on Friday (p.2-3).
Not only does this put the jobs of its 322 employees at risk, the paper continued, but it could also lead to shortages in France and elsewhere.
The Lyon site is the only one in the world where some drugs, including Sanofi's leprosy drug Disulone (dapsone) are manufactured.
Employees and union representatives are warning that closing the site could lead to shortages and contribute to the drug shortage crisis affecting France and the rest of the world.

Former head of drug evaluation France's HTA body joins consulting firm

The former head of drug evaluation at France's healthcare technology body HAS Dr Anne d'Andon has joined Cemka, a consulting firm which helps pharmaceutical companies prepare marketing authorisation request files for HAS, reported Le Canard Enchaîné on Wednesday (p.4).
The weekly satirical newspaper pointed out that despite this enormous conflict of interests, the civil service ethics commission had scarcely stirred.
According to the newspaper, d'Andon has been told she cannot contact any of her former colleagues at HAS and she cannot work with any pharma company which has submitted a request with HAS in the past three years.

France's attempts to tackle HIV lack funds

According to France's national audit office, the less than €150 million budget set aside each year to treat and prevent HIV is insufficient, reports Le Figaro on Friday (p.10).
The report notes that even though France is excellent in terms of HIV research and the treatment of people with HIV, the country is not making good enough use of tools available, such as pre-exposure prophylaxis (PrEP).
Pharmacists, quoted in the paper, are calling for the health insurance to raise awareness of the role they could play in countering the spread of the disease.
One pharmacist said that HIV test kits should be provided free of charge in pharmacies as should condoms until a certain age.

Warnings to appear on paracetamol boxes

Warnings about overdosing and recommended doses are set to appear on paracetamol boxes, reported Le Parisien on Tuesday (p.8-9).
Although there is not any precise data on paracetamol-related incidents, France's drugs regulator ANSM says it has enough information to know it is an issue.
According to official figures, 52% of the French population in 2018 had at least one reimbursed paracetamol prescription and 11% of them had at least six over one year.
The topic was also covered on Wednesday by Les Echos (p.20) and La Croix (p.9).
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