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Italian health minister says legal grounds may exist to challenge EMA relocation to Amsterdam

Country : Italy, Netherlands, Europe

Keywords :
MILAN, Dec 15 (APM) - Italian health minister Beatrice Lorenzin has suggested there may be legal grounds for challenging the decision to relocate the European Medicines Agency (EMA) to Amsterdam if the city is unable to complete the transfer in time, La Repubblica reports on Friday.
This follows rumours that Amsterdam is struggling in its preparations for a new home for the regulator. The paper said the race to host the EMA will not be officially over until 20 January and that an appeal against the decision to relocate to the Dutch capital is not out of the question.
“There have been several reports from London and Brussels about Amsterdam’s ability to provide for the transfer of the EMA and all its staff into a new headquarters before May 2020,” Lorenzin was quoted as saying.
This would be a year later than required by the European commission and might mean the decision could be reconsidered. “If the delay of a year was true, I believe Italy would be right to think there are legal and political grounds for ascertaining whether the decision taken is still valid,” the health minister said.
According to La Repubblica, Lorenzin is not alone in her thinking and the government itself is now following events closely. The paper said it will all depend on whether Amsterdam can have a site ready by spring 2019.
Several other papers, including Il Sole 24 Ore and Il Messaggero, carry the same story on Friday about Lorenzin’s suggestion. Il Giorno quotes the health minister as saying she was annoyed about the procedure which resulted in Amsterdam being selected, and believes that Milan deserved to win.

New assessment methods for innovative drugs

Measures in the Italian budget will provide new methods for the assessment of innovative drugs, the health ministry’’s planning director told Quotidiano Sanità in an interview published on Wednesday.
Andrea Urbani said analysis of how drugs impact on the health and welfare system as a whole, taking into account costs which will not have to be made, will allow for more efficient allocation of resources.
He said he has ordered a gap analysis to be carried out so that the potential of the national health service to provide services more effectively and appropriately can be measured. The results of the analysis are expected in January.
Urbani highlighted the need to identify where spending can make the biggest difference. “Some expenditure should be seen as an investment and not a cost,” he said. “The best example is hepatitis C infection. An investment of 2 billion euros has allowed us to treat 103,000 patients and will allow us to achieve the eradication goal over the next three years.“
He argued that the HCV programme will produce significant savings over time in terms of less admissions, less transplants and less co-morbidities suffered by patients with Hepatitis C.

Piedmont’s competitive tenders to generate drugs savings

Piedmont is looking generate 156 million euros of savings through competitive tenders for drugs and vaccines, La Stampa reported on Saturday.
Its methods have led to legal battles with companies, the paper noted. In one tender the region made pneumococcal conjugate vaccines manufacturers compete against each other for a supply contract. Pfizer challenged the decision in a regional court but failed to have the tender stopped.
In two years, the region has held 184 competitive tenders for drugs, medical devices and services. For drugs and vaccines it is planning to increase the number as products go off-patent, the paper explained.

Molteni to market Titan’s opioid addiction drug Probuphine in EU

Florence-based Molteni is to market Titan’s opioid addition drug Probuphine in Europe, La Nazione reported on Thursday.
Titan has agreed to an exclusive licence for Molteni to commercialise the therapy, which was developed through the ProNeura platform, in markets in the European Union including the UK, Switzerland, Norway, Iceland, Serbia, Macedonia and Albania, the paper said.

MolMed’s shares surge after Zalmoxis reimbursement decision

MolMed’s share price surged almost 14% after it was announced that its drug Zalmoxis was approved for reimbursement in Italy, Il Sole 24 Ore reported on Thursday.
It is the first patient-specific cell therapy based on reengineering of the immune system to allow haploidentical haematopoietic stem-cell transplantation (HSCT). Negotiations with medicines agency AIFA resulted in a 149,000 euros list price being agreed for a single infusion, the paper said.
Italy is the first country to approve reimbursement of Zalmoxis since it was granted marketing authorisation in August 2016, according to Thursday’s Il Messaggero. Negotiations in other countries are progressing, it added.
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