There is a parallel drug market that is hurting us all. But it's legal (and worth billions)

They are 1,556 missing medicines in Italy according to the weekly list published on June 28th by AIFA, the authorization and control agency of the Ministry of Health: Of these, 410 have no equivalent alternatives. This means that necessary care may be delayed or postponed. Even important survival preparations for hospital emergency units are missing.

complaint of Francesca Mannocchi "Me, my illness and the broken pact"
, published in L & # 39; Espresso last week, is not limited to long-term therapies. We are all involved. And June ends with another record. Only a week before, on the 20th of the month, the lack of drugs (whose stopped productions are included) was 1,527, twenty-nine less. And those without equivalent alternatives 398.

The export of drugs from Italian warehouses to northern Europe is a market distortion in recent years . So much so that in early 2018, the Federation of Pharmaceutical and Pharmaceutical Informants' Associations relaunched the warning on its website: "Drug Deficit and Speculation: When Health is Worth Less Than & ## 39, a bribe ".

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The parallel market is considered the main cause of the scarcity of drugs in circulation: the legal possibility for wholesalers, large pharmacies and sometimes even hospitals to resell in other countries of the Union where they pay more, medicines for us. The convenience, for parallel exporters, is given by the price established by the agreements between the AIFA and the pharmaceutical companies on refundable medicines: Italy, Spain and Greece, all affected countries. by the shortage, are among the lowest in Europe. This ghost market whose effects can however be very well perceived, only concerns drugs dispensed wholly or partially by the national health service : those of the band A, available in pharmacies on prescription, the Band H whose use, except in special cases, is reserved for hospitals, clinics or similar establishments. The export obviously does not concern over-the-counter drugs, whose price, even in the countries of Northern Europe, is determined by the direct relation between producer or wholesaler and sellers.

If the pharmacy, which is also hospitable, is unable to provide the medications prescribed by the doctor, the citizen may challenge paragraphs 3 and 4 of section 105 contained in Legislative Decree 219 April 24, 2006. This is a fundamental legal instrument that, in the face of health risks should not be forgotten. It establishes paragraph 3: "The supply to pharmacies, even to hospitals, or to other authorized subjects … of medicines for which the distributor is provided must take place as soon as possible and, in all cases, in the twelve working hours following the request .. "And paragraph 4:" The holder of the AIC (Marketing Authorization, ie the pharmaceutical company) is obliged to provide within 48 hours, at the request of pharmacies, even hospitals, a drug that is not available in the network of

Faced with distortions and the excessive power of the market, we patients are completely alone . And even when the national supervisory authorities tried to intervene, the European Union defended the market and its distortions.That's what it did in 2003, with this communication from the Brussels Commission: "The parallel importation of medicinal products is a legitimate form of exchange within the internal market, based on Article 28 of the Treaty on the Functioning of the EU (free movement of mercy) and subject to exceptions concerning the protection of health and life … ".

The case has grown in scale, the waivers have disappeared. So much so that Poland, Romania and Slovakia, when they tried to limit the parallel export of drugs from their warehouses, were reported in Brussels. The infringement procedure was closed on May 17 last, finally with a new conviction: "The Commission", written in the filing order, "acknowledges that the parallel trade of drugs can be l? one of the reasons for the shortage of the series of medicinal products for human use Reconciling respect for the free movement of goods with the right of patients to access health care is a particularly delicate task, and after careful evaluation, the Commission has recognized the need to consider other means than the infringement procedures … "

This seems incredible: but for Brussels, the free market and thousands of citizens who risk their lives for lack of in Europe, they have the same weight, so that "conciliation" is necessary.

The Commission's objective now is to "collect more information from the Member States and from from other stakeholders to discuss the implementation of the public service obligation and export restrictions. within the working group … ". This is true: it would be enough to attribute the obligations of the public service to the entire supply chain. Together with the badociations of producers, distributors and pharmacists, including Farmindustria, Adf and Federfarma, the Ministry of Health, the Region of Lazio, the Lombardy Region and AIFA signed a pact in September 2016. "The signature of this document demonstrates this widespread commitment. Mario Melazzini, then president and now general manager of AIFA, said at the time: "I can not fail to point out and appreciate the great sense of responsibility demonstrated by all the subjects that are intervened today to sign this document. Very good. "So much optimism had pushed Sole24Ore as his owner:" More drug shortage. "

The warm days of negotiations are obviously very different from those between life and death in first aid We take the Fleomocortid Richter produced by Sanofi: "It is indicated in emergency situations that require rapid availability of high hydrocortisone in the blood … important for survival," says the leaflet It is used for anaphylactic states that do not respond to traditional therapy or for severe trauma, surgical, traumatic, haemorrhagic, cardiogenic, burned, resistant to standard therapy.The drug is deficient from May 22, 2018 to June 30, 2018. : "Production problems – Authorization to import into health facilities for similar substances authorized abroad", prescribed the list of deficiencies of the AIFA.Outside, the price of Flebocortid will usually be much higher, dictated by the emergency situation

Clexane, in the common injectable dose of 4000 IU (international units) of six pre-filled syringes, is a drug that has become rare since April 26, 2018, again for production problems. It prevents the formation of blood clots and is used to prevent deep vein thrombosis in general surgery, orthopedic surgery and in patients at risk of thrombosis forced to lie down for long periods. The price agreed by Aifa with the producer Sanofi and paid by the national health service is € 32.70 per package: € 5.45 per dose. In Germany, the price reimbursed by the state raises to 11.65 euros per dose, depending on the type of packaging. The list of deficiencies also contains Igantet, an important drug for tetanus, effective anti-haemorrhagic and anti-rheumatic

"The parallel importation of drugs, allowing the purchase of drugs at lower prices" explains Fabrizio Gianfrate in the research "The parallel drug trade in Europe", "represents an advantage for payers, public and private, ie health systems and families". It is estimated a turnover of about fourteen billion euros, seven percent of the overall European pharmaceutical market. For some specific drugs, in Germany, Great Britain, Denmark and Norway, parallel imports account for 55-63% of consumption. It is estimated that 16% of medicines sold in Greece are diverted to richer European countries

Even in Italy, any wholesaler or distributor who pays for the goods at the agreed national price may find it more profitable to sell a certain medicine on the market. Along with exporting the channels rather than distributing it to the pharmacists of its customers: who just declare that the drug is missing without explaining why. At this point, the pharmacy network signals the absence of the region. And finally the drug ends up in the list of AIFA. Although the pharmaceutical companies are often regularly distributed

The mechanism thus allows savings on health expenditure in the states of Northern Europe which according to their GDP (gross domestic product) have contracted official prices higher with producers. A shortcut that reveals the study of Gianfrate. In Germany, the pharmacist must sell at least 7% of imported medicines in parallel and the parallel drug has a price of at least fifteen percent lower than the national price list. In the Netherlands, pharmacists are encouraged to sell imported medicines in parallel because they are reimbursed at 94% of the national price and can keep the difference between the value reimbursed and the wholesaler's purchase price, while the Dutch government recovers around 7%. Pharmacist's Recipes

In Denmark, the pharmacist must inform the patient of all alternatives, including medicines imported in parallel and in Norway, doctors are encouraged to prescribe them. In Sweden, pharmacies belong to the state, pharmacists must provide the cheapest drug among the equivalent alternatives and parallel drugs are the least taxed.

In the United Kingdom, most pharmacists earn: they can retain the difference between the price paid by the state and the discounted purchase price of the parallel drug, while the government recovers a portion of wholesalers' revenue based on the national import quota. For Britain, the legal kidnapping of drugs from other European countries allows a saving of one billion pounds a year: one billion and one hundred and thirty million euros

The The process requires that drugs be repackaged to translate boxes and pamphlets into the target language, without the supervision of pharmaceutical companies. "This introduces safety and quality risks for repackaging, if it is done improperly," according to Fabrizio Gianfrate's research, "and promotes the growing phenomenon of counterfeiting." Last year, AIFA announced that drug theft in Italy dropped from eight hundred thousand stolen parcels in 2013 to eighty thousand in 2016. Without harming the contrasting action put in place by the agency and the antisofistazioni core of the carabinieri, it can not be good news: this means that the parallel market is now even more profitable and easy than the illegal market.