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THE DRUG IS LESS SUFFOCATED

Read less and check more. This is what Farmindustria asks the institutions "not to reduce, but to multiply the effectiveness of the law"

The appeal comes from a conference on the subject, organized today in Rome by the association of pharmaceutical manufacturers. "Too many laws on the same subject increase the interpretative area, slowing down entrepreneurial activity", says Sergio Dompé, president of Farmindustria, who therefore calls for "less bureaucracy, which costs dearly to companies, more self-certification and more controls on the whole of the drug". Controls also necessary to "withstand the shock wave" of the increase in illicit drug trafficking and counterfeiting, linked to the enlargement of Europe and emerging markets. "To make our Public Administration more efficient - says Dompé - it is necessary to have half the laws, a quarter of the possible interpretations and double the controls. With a relationship between companies and the PA which, for each request of the former, provides for pre-established and rewards or penalties depending on the results. A logic similar to that of the Stock Exchange, where you are punctually monitored and, for every mistake or deviation from what was promised, you are punished in the quotation of the share". The drug companies are therefore asking for a 'lightening' of the laws and say they are in favor of greater controls, but also ask that the latter "not only concern the pharmaceutical sector but put the entire health system under scrutiny". Therefore, businesses ask to "be in a position to operate and respond responsibly for their actions in a clear, stable and coherent legislative and regulatory context at regional and national level. A context therefore without gray areas, cross-references that are difficult to manage and tangles of skills that are impossible to disentangle. Clear rules and in the number strictly necessary to guarantee the protection of citizens and respect for the institutions. But also the freedom to undertake, which must be encouraged by the law and not limited".
The costs of bureaucracy – recalls Farmindustria – are "a heavy bill for businesses". "In Italy, for example – explains Dompé – administrative costs in 2006 were equal to 4.6% of GDP and entrepreneurs take 90 days a year to comply with administrative obligations and bureaucratic procedures". The latter "cost more in Italy than in other countries (5,564 euros per capita against 4,115 in Germany, 5,182 in the United Kingdom, 3,247 in Spain): a difference that arises not from the cost of personnel but from that for the functioning of the 'public car', the highest in the European Union". Pharmaceutical companies "naturally do not ask for a reduction in the level of national and international regulation of the various phases of drug experimentation. The rigor achieved – continues Dompé – must indeed be maintained because it is an indication of the safety, efficacy and quality of the product". However, they are asking for "fewer laws in the public administration, which is also caught between obligations, procedures, quibbles, which are not always necessary and sometimes useless or harmful. And therefore fewer formats to fill in and files to do and more computerization, speed and simplicity in practices. And names that correspond to faces with certain and verifiable individual responsibilities". In our country - the industrialists acknowledge - "the itinerary in this direction has been started and several things have changed. But the system as a whole is still too slow, not very reactive, with vast areas of deresponsibility in which citizens and businesses remain rarely get caught up in. More space also for self-certification

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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco