Press review

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Spain's tax changes threaten €300 million pharma R&D investment

MADRID, 4 Oct (APM) - Spain's government has announced plans to increase public R&D expenditure which, paradoxically, will involve companies operating in Spain paying 15% more tax, jeopardising €300 million of pharma investment, financial newspaper El Economista reported on Thursday.
According to consulting firm Ayming, president Pedro Sánchez will need €8 billion to fulfil his R&D plans and he is going to obtain those funds from some of the companies which devote the highest percentages of their revenue to research. The newspaper called the move something along the lines of: "I will buy dinner, so do bring your wallet."
Sánchez' plan will eventually damage private research in Spain, El Economista said. Ayming forecasts a €293 fall in tax exemptions granted to different industries, pharmaceutical companies, which devoted €1.1 billion to R&D in Spain last year.
The financial quoted Rafael Legasa, from Zabala Innovation Consulting as saying that the abolition of tax exemptions coud force companies to take part of their R&D premises overseas to countries where tax plans are more favourable.
According to Zabala, up until now, tax exemptions granted to innovation companies have proved to be a useful tool to boost R&D. "They should be stable, avoiding uncertainty."
The abolition of tax exemptions will directly impact pharma's R&D expenditure in Spain. The industry devotes €130 billion to R&D globally. Spanish subsidiaries need to compete to attract as much of that money as possible, which will be more difficult now.
El Economista quoted sources from Spanish branded pharma lobby Farmaindustria as admitting there is concern about the move.
The sources said: "Pharmaceutical companies have assessed the impact of the plan and have agreed that such a change would certainly be a problem, because it would affect their capacity to fund their own R&D projects."

Pharmacists representative blames low prices for shortages

On Thursday, financial newspaper Cinco Días carried a column about the growing problems in drugs supplies due to an increase in "safety alerts, stock insufficiencies, drug tenders and price drops". The author is Rubén Martín, member of the board of Madrid's pharmacists association Adefarma.
It is increasingly frequent that community pharmacies fail to sell clients the medicines they want to purchase, he said. In Andalusia region, where drug tenders were implemented by the government years ago, it can happen as often as 50% of the time, Martín argued.
In Madrid region, where there have been no tendering-like procedures, the figure is still alarming (10%), he added.
One of the causes is a recall or withdrawal by Spanish regulator AEMPS. A shortage can occur due to low stock levels or manufacturing difficulties. Drug tenders are the third main cause, followed by falls in prices.
In Spain, the prices of some drugs are extremely low because the management of drug expenditure is not based on efficiency. Instead, it follows the dynamics of continuous drops in drug prices. Omeprazole, which used to cost €30 euros, is currently sold at €2.42, he added.
Solutions are being sought but this must not hide the fact that the situation is unacceptable, he said.

Ranitidine-containing drugs withdrawn

Spanish regulator AEMPS has withdrawn all ranitidine-containing drugs from the market, it was widely reported on Wednesday and Thursday.
A total of 16 gastrointestinal drugs have been pulled from the market over safety concerns about the potential presence of carcinogenic impurity N-nitrosodimethylamine (NDMA). (APMHE 64588,64500)
According to ABC, the European Medicines Agency raised the alarm about NDMA. After the substance was detected in some batches, AEMPS decided to pull all the medicines in this category as a precautionary measure.
On Friday, financial newspaper El Economista reports that a total of six million packages of ranitidine-containing drugs are sold in Spain annually. The financial quotes data by medical consulting firm hmR as saying that annual sales of these drugs are €30 million.
Companies which sell branded ranitidine in Spain include Zantac and GlaxoSmithKline, whereas Cinfa, Normon, Alter, Apotex, Aristo, Aurovitas, Francisco Durban, Mabo-Farma, Mylan, Pensa, Ratiopharm, Teva, Vir and Kern Pharma sell generic versions.
Daily newspapers 20 Minutos, El País, El Mundo, Hoy and a number of medical journals also carry the story.

Cheap drug found to treat rare paediatric disease

A Spanish research team has used acetazolamide, a €2 euros drug, to treat a rare disease called PMM2-CDG, which causes cerebellar syndrome and stroke-like episodes (SLEs) in children, daily newspapers El País and ABC report on Thursday and Friday, respectively.
Acetazolamide is currently prescribed to prevent high-altitude illness, heart failure, glaucoma and epilepsy, ABC notes.
El País reported that there is no specific treatment for this syndrome, which is under diagnosed. The team plans to recruit patients for a Phase III study with children from other countries. There are over 500 cases of PMM2-CDG in the European registry, the newspaper added.
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