Press review


Germany's Health Minister pushes through bills on mandatory vaccination, pharmacies and payer structures

BERLIN, 19 July (APM) - Germany's Health Minister Jens Spahn pushed three bills through the ministerial cabinet on Wednesday - on vaccination, pharmacies and payer structures, Handelsblatt reported on Tuesday (p4-5), Frankfurter Allgemeine Zeitung (FAZ) (p8 & 15), Handelsblatt (p14) on Wednesday, Süddeutsche Zeitung (SZ) (p1 & 27) and FAZ (p33) on Thursday.
Under the vaccination bill, children and staff of community facilities will have to be vaccinated against measles from March 2020 (APMHE 63735). The bill on 'local pharmacies reinforcement', will maintain fixed prices for prescription drugs to forbid discounts by mail-order pharmacies.
The third bill, reforming the statutory payers' joint medical service (MDK), contains a provision that public sessions of higher health technology assessment (HTA) body G-BA must be streamed live online.
Moreover, Spahn announced plans to merge health data institute DIMDI with drugs regulator BfArM to make patient registries hosted by DIMDI available to BfArM, FAZ said.
It was widely speculated that Spahn would leave the Health Ministry to succeed Ursula von der Leyen as Minister of Defence, as von der Leyen was elected President of the European Commission on Tuesday, FAZ added.

Bayer damages slashed from $80 million to $25 million

U.S. federal judge Vince Chhabria slashed a damages award Bayer has to pay to Edwin Hardeman who blamed Roundup weed killer for his cancer, from $80 million to $25 million.
FAZ (p22), Handelsblatt (p20) an SZ (p18) reported on Wednesday and weekly Wortschaftswoche (WiWo) on Friday (p11) (APMHE 63721).
However, Chhabria clearly said that the actions of Monsanto, now a Bayer subsidiary, are "reprehensible": the judge has taken his decision "on technical grounds", as the jury chose the punitive damages of $75 million too high in relation to the compensation for Hardeman of $5 million, Handelsblatt and SZ said.
Following this "clear tendency", settling would be of advantage for Bayer and for plaintiffs, a WiWo reporter said in an opinion piece.

Bayer's chairman pledges more transparency for investors

Bayer's chairman Werner Baumann has promised more transparent communication strategies for investors in an interview with monthly Manager Magazin on Friday.
After an unprecedented rebuke vote by shareholders for the executive board (APMHE 62800), the directors met Bayer's 25 biggest investors to discuss its strategies. However, the board cannot share certain information, such as Bayer's defence strategy or its position in mediation over glyphosate litigation, Baumann said.
So far, an external audit commissioned in May (APMHE 62952) has not found any evidence that Monsanto employees have broken the law by listing names of glyphosate opponents and advocates.
Even in light of litigation and reputation risks which arose with Bayer's acquisition of Monsanto, Baumann considers the "strategic logic of the acquisition intact", he added.

Only one in four new drugs show added benefit

German health technology assessment (HTA) procedures have found an added benefit for patients for one in four new drugs only or drugs with new indications, from 2011 to 2017, according to an article published by lower HTA body IQWiG in British Medical Journal, weekly Der Spiegel reported on Saturday (p101) (APMHE 63665).
As approval only required testing drugs against placebo, data against existing standard therapies are often lacking for assessments. For more than half of the assessments, no evidence was available to show they are superior to the designated comparative therapy.
Physicians could not know if the new drug was better. Doctors nonetheless tended to prescribe those, which is expensive and could be harmful to patients.
IQWiG suggested that higher prices for new drugs "showing a real benefit" could give incentives to the pharma industry to promote "real innovation" instead of spending "millions for developing drugs that differ only slightly from older therapies", Der Spiegel said.

Bayer leading clinical study based on real-world data

Bayer is setting up a first clinical trial with real-world data provided by digital sensors to monitor chronic heart failure in 100 patients, Handelsblatt reported on Thursday (p22-23).
The data collected in this observational study should become a baseline for future drug testing. For instance, digital biomarkers could be identified to assess chronic heart failure or drug efficacy - which could accelerate clinical development, Handelsblatt said.

Chair of doctors' association calls for national drug reserve

Klaus Reinhardt, chair of national doctor's association BÄK, has called for a national drug reserve independent from manufacturers and retailers to prevent shortages, FAZ reported on Tuesday (p18).
Reinhardt is not convinced that the measures in place are sufficient - like a list of shortages kept by drug regulator BfArM and a periodic jour fixe between the pharma industry, physicians, politicians and authorities. Pharmacists' and hospitals' associations have been calling for a national drug reserve.

Shortage of MSD's oral contraceptive Zoely in Germany

A shortage over the past two months of Merck Sharp & Dohme's oral contraceptive Zoely in Germany has prompted pharmacists to order the drug abroad. MSD forecast the shortage, caused by packaging and manufacturing issues, to last until August, weekly Der Spiegel reported on Saturday (p66).
Global drug manufacturing, under which companies in different countries are involved, is one reason for drug shortages - for Zoely, the marketing authorisation holder is the Irish company Thermex, French Delpharm is the manufacturer and batches are released by MSD in the Netherlands, Der Spiegel said.

Regional television chain appeals pharma wholesalers' accusations

Regional television chain RBB appeals pharma wholesaler Lunapharms's accusations of imbalanced reporting of "speculations" after Berlin regional court said that some of RBB's reporting was "prejudging", FAZ reported on Tuesday (p15).
Since July 2018, RBB has reported several times that Lunapharm imported cancer drugs stolen in Greek hospitals by an international criminal network (APMHE 59468).

Alternative practitioner given two years probation after three cancer patients died

The regional court of Krefeld near the Dutch border has given two years probation to an alternative practitioner after three of his cancer patients died in 2016, SZ (p8) and FAZ (p8) reported on Tuesday.
The practitioner had used a scale that was not suitable to weigh very small quantities of drugs, causing three- to sixfold overdosing of an unapproved substance. The case has caused a debate on the approval procedure for alternative practitioners, FAZ said.

Sandoz partnering with Ares Genetics

Novartis' generics division Sandoz has been collaborating with Austrian biotech Ares Genetics to jointly develop a digital platform for development and life-cycle management of antibiotics since December 2018 - the partnership is testament to Austria's strong position in artificial intelligence (AI), FAZ wrote on Tuesday (p24).
Ares Genetics can predict with a precision of 98% which antibiotic works for a specific germ, based on its database of genetic information of more than 40,000 bacteria and their drug resistances, FAZ said.

Fewer HIV deaths due to antiretroviral drugs

In 2018, deaths due to HIV declined by a third to 1.2 million, as more than 60% of all HIV patients receive antiretroviral drugs (233 of 37.9 million patients). Moreover, the number of people newly infected with HIV declined by 16% to 1.7 million globally, FAZ reported on Wednesday (p7).
In South Africa, the numbers of new infections and of deaths could be reduced by 40% each.
However, 40% more patients in Eastern Europe and Central Asia became infected. 95% of these patients' access to HIV drugs is limited as they are drug users, men who have sex with men, transgender, sex workers and inmates, FAZ said.

Novartis could settle U.S. corruption lawsuits for up to $700 million

Novartis has set up provisions of $700 million settle U.S. corruption lawsuits against several states and the federal government, the Swiss company's chief executive Vas Nara­sim­han said in a call with reporters, FAZ reports on Friday (p75).
According to FAZ, this sum seems moderate, as the settlements were expected to cost Novartis more than $1 billion, FAZ says.



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