UXA steps down from Andalusia's generic drug tender, others to follow - expert

13/01//2014. APM. Belén Diego. UXA Farma has said it will not be able to meet its obligation to exclusively supply pharmacies in Andalusia with antihypertensive enalapril from February 1, prompting an expert observer to predict others will follow suit putting the potentially illegal generic contracts under more pressure.

Speaking to APM on Friday, Ángel Luis Rodríguez de la Cuerda, director of generic manufacturers' association AESEG, said that this could have been predicted, given the "minimal structure" of some of the companies which signed the two-year sole-provider contracts with the region.

He had warned of such a risk months ago and Rodríguez told APM last week that UXA may be the just the first of a series of firms which will fail to meet their contracts.

Andalusia, and other regions looking to cut drug spend, have already run into legal problems with the approach and had to combat moves by the Madrid government to stop their tenders.

Alternative company in place but two months without deliveries

A two-month gap in supplies of enalapril is expected between February and April, because regional health authorities have named Francisco Durban, a regional firm based in Almería, as substitute for UXA, and Durban will not be ready to supply enalapril before April, APM has learnt.

Rodríguez predicted that, out of a sense of responsibility, other manufacturers "will come to the rescue". However, it is possible that some do not have enough stock to supply Andalusia, "after all, someone else had exclusivity and it may not be in their manufacturing plans," he said.

He also said it is quite possible that patients will see their drugs changed in presentation up to four times during the gap in supplies. "Which may be confusing and is totally unfair, since other Spanish patients do not have to face such difficulties".

Generics company mulls legal action against MP accusing poor quality

While a sceptic of the discounts contracts, Rodríguez told APM he does not agree with right-wing senator, Jesús Aguirre, who accused Andalusia of granting exclusivity in drug supplies to companies which adopt poor quality procedures.

"Any drug approved in Spain has the green light of the drug agency AEMPS, whose authority we do not question. It is just a matter of structure", he said.

Aurobindo is one of the companies that won supply contracts and speaking to APM, Gabriel Díaz, head of Aurobindo Spain, said the company does not want to enter "this war". But its legal team is studying Aguirre's comments in case a defamation lawsuit was appropriate, he said.

Aguirre said 70% of the companies included in Andalusian drug tenders are located in Asia, "bringing no employment or benefits to Spain". Aguirre said the tender creates inequity across Spain because patients in Andalusia are receiving drugs manufactured in Asia, including some from two companies whose medicines are not allowed into the U.S. by the U.S. Food and Drug Administration.

Díaz said the company would rather not get involved in the confrontation, but pointed out that questioning the quality of drugs sold in Andalusia implies distrust of the system as a whole. He said: "Each and every drug sold in the region has been approved by the Spanish drug agency AEMPS. Does Mr Aguirre mean approval does not guarantee the quality of those medicines?"

In the summer, Aurobindo won challenges to Madrid's decision to reduce drug prices following the regional tender.

Rosa Pardina, OneDose Pharma's CEO, told APM: "Being in the tender is actually a recognition of our high quality standards, with a number of requirements and guarantees having been scrupulously analysed before eventually signing the contract with the region's government."

Concerning the "Asian argument" of Aguirre's comments, Pardina said she had got to know some of the drug manufacturing premises in India and can confirm some are state-of-the-art plants with high quality standards.

Speaking to APM on the phone, Ramón Vila, head of Swedish Bluefish Pharma, said some kind of action may be taken against Aguirre's criticisms. Vila said: "We are talking about prescription drugs which have been approved by the Spanish agency."

According to Vila, tenders could be a very effective way of contributing to the national health system's sustainability "such as they are in Sweden", that is the reason why they joined in the first place.

"In most European markets, the decision of choosing one drug over another one, once a series of quality standards are met, lies in the hands of the government. Andalusia is evolving from a system where physicians and pharmacists decide, to one in which those who pay, namely, regional governments, make that decision," he said.

MADE IN SPAIN

Enrique Ruiz, head of Vir, told APM he had been reluctant so far to talk about the matter, but after months of "continuous attacks" a response was needed.

Ruiz, whose company has been in all three procedures in Andalusia, said that contrary to what Aguirre says, 40 million out of the 58 million units provided in the tenders were actually manufactured in Spain, with Vir being the company which supplied the most, but also naming others whose manufacturing plants are on national soil.

The total contribution to the health system has reached 123 million euros (which firms in the tender give the region as a contribution to healthcare in exchange for signing exclusivity contracts).

He added that they have been operating in Spain since 1939 and have a number of agreements going back decades to supply to big pharma (including Lilly, Apotex, and many others). Ruiz disregarded Aguirre's comments as "pure ignorance, or maybe just the words of someone who simply says what his party tells him to" (Aguirre's party, in office in Madrid, opposes the tender, as it was launched by socialist PSOE).