Maurizio Cini

The answer to this question is: yes!
And how could it be otherwise? The legal doctrine has consolidated the principle according to which the chemist’s profession, in the traditional meaning of the term which still prevails, is a liberal profession which, to be practised, needs a business. The pharmacy and pharmacists therefore represent an inseparable combination. In fact, for some years the pharmacy of services concept has grown, with a few grumbles and incidental criticism. The health of citizens is considered as a fundamental asset by Italy’s Constitution, and for this reason the State, Regional authorities and City councils organize a complex network of health and social services which range from general practitioners to specialist clinics. In this setting of activities dedicated to the health of the population, pharmacies play a very important role of intermediation between citizens and medicines, belonging to the basic health care sector. In fact pharmacies are present everywhere throughout the territory and within everyone’s reach at any moment of the day and on any day of the year. The pharmacy is also a more complex centre of health services, in which citizens are able to benefit from the various services that are associated with treatment, knowledge of physiological parameters, health information and access to services of biomedical nature. The following are part of the pharmacy’s authority:
- the supplying, conservation and dispensing of medicines;
- giving advice on the use of medicines and their selection;
- the extemporary preparation of medicines;
- the supply of specialist and supplementary services in collaboration with the facilities of the National Health Service;
- the promotion and support of initiatives aimed at protecting citizens’ rights within health education and the prevention of illnesses, access to national health and information services;
- the medicine-supervision.

The quality
Some of these authorities may appear obvious but, as we will see afterwards, now they must be re-examined under the magnifying glass of quality. Instead the others represent, besides an undeniable professional duty, an anchor for pharmacies which increasingly find themselves at the mercy of the free market winds, competition and the dangerous principle on the basis of which consumers do the choosing, almost as if the pharmacy were a draper’s shop or a restaurant. In a situation in which quality increasingly takes on a more dominant role in the supply of goods and services, where certification by now seems to have become an integral part of any product, the pharmacy cannot avoid this logic. However, it is fundamental that the guarantees of quality originate spontaneously from the category, but not imposed by law by those who have a vision of the pharmacy from the outside, or is inspired by interests that only apparently seem to coincide with those of citizens. Some examples already exist with the services charters which, in some provinces, have been distributed to pharmacy customers. It concerns a kind of contract with which the pharmacy undertakes to operate by providing, for each service available, the indication of the factor of quality, the indicator and the standard level guaranteed. To give an example, in a services charter, the information on the medicines has, as a factor of quality, the authority of the service personnel, verifiable by the customer by means of a badge, in addition to the association’s emblem affixed on the white coat (indicator) which carries the graduate’s name and register enrolment number (standard).

The central role of the pharmacy
For a long time the attention of the Legislator has been directed at pharmacies. Since the beginning of the last (XIII) legislature, bills have flourished to liberalize the pharmaceutical service with the “noble” aim of generating competition between pharmacies which, in this event, could only be uncontrolled with the easily predictable result of a lowering in quality which - then yes! – would justify the direct distribution of all the ethical medicines by the public facilities and, for the OTCs, entry into large-scale distribution. The motives at the roots of such proposals are various and to the incentives towards the free market is added the illusion that, eventually, a greater number of pharmacies (in Italy there is one for approximately every 3,500 inhabitants) may lead to a reduction in pharmaceutical spending even assuming a network of pharmacies operating within the NHS and another which does not, the latter, being managed by any chemist on the register wishing to do so. Fortunately such proposals did not catch on in the last Legislature but, as we will see further on, in the current one the category will need to have an active proposing role, instead of waiting for possible destabilizing proposals only to then defend, when possible. Well the efforts made and some experimental examples conducted in some provinces have led to the recognition, at least in one field, of the pharmacy’s fundamental role in the widespread distribution of all the medicines. I refer to the recent passing into law of the Executive Order 18.9.2001, no. 347 (law 16.11.2001, no. 405) which provides for the possibility of entering into agreements with pharmacies (public and private) for the distribution of all those medicines, and others still, which until now have been distributed, in many regions, almost exclusively in direct form by the Local Health Authorities. It concerns a possibility, not an obligation, that however allows dealing with, locally, the different situations with the effect of keeping the pharmacy’s cultural image in a central position in citizens, a position that would be irretrievably lost in the event of a gradual disappearance of ethical medicines from pharmacies open to the public.

The proposal
The role containing a proposal of the category was mentioned. So ten years on from the last reorganization law of the pharmaceutical service, which in my opinion has done more bad than good, a new prescriptive intervention cannot be put off now, which may provide certainties for a sufficiently long time period (at least 15 years) avoiding the issuing of by-laws and various amnesties, almost always for usum delphini. It therefore needs the courage (if one hasn’t got it, then it can’t be given, Manzoni let Don Abbondio say) to be far-sighted and propose (also indirectly according to the needs of politics) a pharmacy arrangement that, without profoundly disrupting the current system, does not lay itself open to external criticism. How can it be done? Which aspects are to undergo change? First of all, a fundamental choice of field needs to be made. Do we want a public pharmacy-service or a commercial pharmacy? If this dilemma is not answered it is impossible to think about credible proposals, demonstrating the wish to have the proverbial cake with its familiar consequence. What is to be understood by public pharmacy-service? It concerns a pharmacy model similar to the current one, but relieved of some troublesome frills which give the excuse, to those wanting to destroy it, to criticise its privileges represented by the heir transmission procedures and, above all, entry through extremely slow and complicated public examination mechanisms. On the other hand, the commercial pharmacy, inevitably being of liberal establishment, will no longer envisage the need to regulate entry or transmission between living persons or mortis causa. A hybrid of the two systems will never resist for a long time without putting into question the existence itself, for the simple reason that each time a lawful claim is put forward it will be liable to be squeezed by other aspects. The result would lead to being subjected to attacks with administrative measures, i.e. with the presentation of bundles of bills more closely resembling warnings than sensible expressions of legislative will. It was not a coincidence the flourish of bills for the deregulation of the pharmaceutical service soon after the controversy which arose following the introduction of the progressive discount in favour of the Local Health Authorities, at the end of 1996, and the consequent possibility of crossing over to indirect assistance by the pharmacies.

The bills
At present three reorganization bills of the pharmaceutical sector have been introduced. Some, in part, follow the unified text (proposer: Sen. Bernasconi of DS party) which, in the last Legislature, occupied the news pages of the sector’s magazines for months to then be thwarted by a new bill, of totally different content, however much coming from the same political side (MP. Giannotti). The approach that these texts create for the sector is nevertheless always partial; they add innovative elements to the existing prescriptive body without repealing or, simply, quoting the previous regulations thus creating the presuppositions for the most varied interpretation. The predictable result, in the case of passage, is full of contentious procedure but, without overdoing the pessimism, a weighing down of the whole administrative machine can be envisaged which must give practical implementation to the innovations introduced. It is strange that still nobody has thought of creating a completely new text that regulates the organization of the pharmaceutical service in toto and repeals, expressly, each previous regulation. Who knows why? Perhaps, also here it is a case of remembering that one commits a sin in suspecting but ... At this point the reader will be wondering what I would propose in this new single text of the pharmaceutical service. It is certain that the drawing up would require a lot of time and space but, above all, constant consultation with the parties at law: politicians and chemists. Otherwise, perhaps, a fine text would be obtained, but without any chance of it being passed. The elements to be introduced should safeguard the current system of the territorial and demographic planning (personnel plan) introducing however an effective system for the territorial redistribution (decentralization) also outside the municipal boundaries. Since, do not forget, the current actual inhabitants/pharmacies ratio is about 3,500 in perfect agreement with the European average, if not lower. This approach could appear too conservative but, if one analyzes it carefully, it represents a real revolution, indeed more effective than a mere reduction in the quorum. With regard to this solution, which would give guarantees of continuity also much as it concerns the importance of the companies, a larger component of political journalism needs to be provided to pharmacies, putting in qualitative service parameters that take company dimensions into account, easily identified on the basis of the volume of business. The wide range of services indeed offered now or anyhow provided for by law, such as the measurement of arterial pressure, essential diagnostic tests, the reservations through the CUP (reservation centre) services and medicine-supervision, up to now not completely entered into pharmacies, calls for proportionally dimensioned facilities and personnel. Also the supervision on the pharmaceutical service, as it is now organized by the Local Health Authorities, does not constitute a sufficient guarantee. The two-year periodicity is not always observed and the preparation of the same members of the inspection boards often do not offer adequate capacity.

Pre-emption and the chains
An aspect not to be neglected concerns the fate of the municipal pharmacies, managed in their various forms provided for by law and that involves considerable preoccupation, especially in the Italian areas where their concentration is higher. It is essential that the bills provide for the abrogation of the regulation on pre-emption by the city councils. Two of the bills presented mention the subject only briefly, with a hasty approach of the phenomenon, envisaging the alienation of municipal pharmacies, i.e. their management through mixed companies. If however, for various reasons, it will not be possible to dismantle the facilities that have emerged especially with foreign capital, it will be necessary to allow private pharmacies adequate organization of services to be able to confront these realities. This will have to occur in a strictly professional field with the sole aim of providing a public service (or at least of public necessity) and with the mediation of the admission organizations already in existence, such as the trade-union associations of pharmacy owners, without ever allowing economic and financial circles to take possession of those managerial aspects which concern the owner’s professional province. If it is not so, pharmacies will be easily accused of putting profits and financial ventures first, just like the multinational chains, while neglecting the primary aim of health protection.

Conclusions
Some of the comments made will seem obscure or send cryptic messages but, with a little attention, one can understand how, in a difficult section like that of health, it is necessary to closely follow the country’s socioeconomic needs by adapting gradually, so as not to be in the position, some day or other, of being unprepared to face new problems to which pharmacies of high entrepreneurial organization may also find difficulty in adapting. If the suggestions made, after sufficient consideration, become the theme of a debate and, above all, of a united proposal, I believe that a lasting reform of the pharmaceutical sector will begin in this Legislature, giving a stable arrangement to the pharmaceutical service and being able to confirm that the pharmacy is a public service.

Maurizio Cini
President of the Biosphere Field
of the University Librarian System University of Bologna

(trad. Interpres sas, Giussano)

CURRICULUM VITAE