The Development of Russian Legislation in the Field of Pharmacy in the late 17th - early 19th Centuries.

Phedotov Daniil Andreevich Master's student, Department of Theory and History of State and Law, Faculty of Law, St. Petersburg State University 199034, Russia, Saint Petersburg, Saint Petersburg, Universitetskaya Embankment str., 7-9 phedotovdaniil@mail.ru Other publications by this author     Melnikova Yuliya Dmitrievna Specialist student, Faculty of Pharmacy, St. Petersburg State Chemical Pharmaceutical University 197022, Russia, Saint Petersburg region, Saint Petersburg, Professor Popov str., 14 yuliya.melnikova@spcpu.ru

Aleshin Denis Olegovich Master's student, Department of Russian History from Ancient Times to the 20th Century, Institute of History, St. Petersburg State University 199034, Russia, Saint Petersburg region, Saint Petersburg, nab. University, 7-9 denis.aleshin.2016@inbox.ru

Pharmacy is the science of the development of pharmaceutical activity and medicinal knowledge throughout the existence of mankind from primitive times to the present day, studying the problems of research, preparation, control, storage and release of medicines. In this case, we are talking about the manufacture of medicines in a pharmacy according to the main prescriptions reflecting the individual characteristics of the patient. The concept of "pharmaceuticals" appeared at the beginning of the XIX century, when there was a need for large-scale and more cost-effective production of medicines. In this article, the subject of consideration is pharmacy in its classical sense.Traditionally, Russian pharmaceutical science counts its history from the beginning of the XVII century and the establishment of the Pharmacy Order.

However, for more than two centuries, the implementation of pharmacy, like most other fields of medicine, was regulated only by separate, unstructured and inconsistent legislative acts. The situation changed in the first third of the XIX century, when a decision was made at the highest level on the need to systematize existing legislation, which resulted in the creation of a Complete collection of laws of the Russian Empire.

The Complete Collection of Laws of the Russian Empire (hereinafter – the Complete Collection of Laws) is the most massive layer of empirical material for the study of the official history of Russian legislation. Nevertheless, despite its monumentality, this complex is not without drawbacks, such as: incompleteness and inaccuracy of the transfer of the subject of regulation^[29]. An attempt to explain the difficulties that arose when compiling a Complete collection of laws was made by its compiler, M.M. Speransky, in the work "Review of historical information about the code of laws"^[32]. He noted that until 1802 there was no general repository of issued regulations or a register of their publications, and therefore it seems natural that some regulations in the process of compiling the collection could be lost in total, or were not discovered in time, or were irretrievably lost as a result of the general clerical disorder on the places, the effects of fires and other factors.

Taking into account the existing shortcomings of the Complete Collection of Laws, we chose it as the main source and statistical base of the study, since the purpose of the work is to show general trends in the legislative registration of pharmacy, for which the data available in it will be sufficient.

The relevance of studying the problem of legal regulation of pharmacy is due to the fact that, despite the high scientific interest in the history of medicine, as one of the leading areas of interdisciplinary research, there is an extremely limited number of papers on the issue under consideration, mainly presented by general lecture courses for medical students^[4].

This state of affairs may be due to the predominance of scientific interest among professional physicians and historians engaged in research in the field of medical history in Russia, to the processes of discovery and development of medical practices or to biographies of outstanding physicians of the past, while interest in the study of the history of individual fields of medicine is rather poorly developed.

The object of this study is the process of legislative regulation of pharmacy in the late XVII – early XIX centuries. The subject of the study is a wide range of normative legal acts presented in the Complete Collection of laws of the Russian Empire.

The purpose of the study is to consider the legal regulation of the pharmacy sector in the late XVII – early XIX centuries, using the methods of historical heuristics and general statistics.

In order to achieve this goal , the following tasks were set as work tasks ::

·        Identification of regulatory legal acts related to the legal regulation of pharmacy from the general array of legislative acts of the late XVII – early XIX centuries.;

· Structuring and classification of such acts depending on their content;

·        Identification of regulatory aspects;

·        Bringing the obtained analysis data into the form of statistical data.

The lack of attention of researchers to the topic of pharmacy development in Russia actualizes the problem of clarifying the time of formation of this medical direction. Here are a number of opinions of researchers.

The dean of the Medical Faculty of Moscow University, a life doctor and one of the first researchers of the history of medical practice in Russia, V.M. Richter, believed that the formation of pharmacy in Russia should be attributed to the opening of the first pharmacy in Moscow, created by order of Ivan the Terrible in 1581^[6]. However, N.Ya. Novombergsky expressed the opinion that the formation of "potions" and "medicine" occurred much earlier and originates from "healers" and "herbalists". In his view, their presence in Russian medieval society can be considered as an earlier element of the systematic development of the pharmaceutical industry in Russia^[9]. However, already at the turn of the XVII-XVIII centuries, the expediency of the existence of "potions" and "green shops" was denied, as evidenced by the publication of the decree by Peter I of October 27, 1701^[1]. In this decree, it was prescribed to liquidate the "green shops", concerning which it was said: "The Green Row, that in China-city, and along the streets, where there are shops in China and in the White City, in which goods are traded and sold, all sorts of potions and suits, as if for medicines, and so on there will be no shops, no potions and herbs, and suits, and medicines for anyone in those places to trade or sell past pharmacies, and that green row along the streets and intersections of the shops to clear and sellers with that product to leave the Town Hall" ^[31]. On November 27, 1701, the emperor issued a certificate for the right to open the first public pharmacy in Moscow, in February 1714, "by his imperial majesty's nominal verbal decree", a vegetable garden was founded on Aptekarsky Island, which for two decades provided state pharmacies with medicinal plants ^[26].

Therefore, taking into account the opinions existing in historiography and based on our own acquaintance with the sources^[10], we are more inclined to rely on the arguments and materials given by N.N. Koroteeva^[7]. According to her concept, the formation of pharmacy in Russia dates back to the second half of the XVI – first half of the XVII centuries, which was largely due to the import of foreign medicines and materials primarily for the royal court. According to R.G. Skrynnikov^[30], during this period there was a process of institutionalization of the pharmacy business, manifested in the establishment of the Pharmacy Order, which was first a court institute serving the royal family, as well as a circle of nobility close to it, then took over the functions of the central, equated to the collegiums, state institution in charge of all military medical affairs in country. The origin of pharmacy in Russia from the court pharmacy also explains the tradition of strong state control of pharmacy and the production of medicines, manifested in legislative acts^[3].

Despite the fact that the Pharmacy Order was established in 1632^[2], the normative legal acts relating to the early stage of the body's activity have not been preserved, and therefore in the Complete Collection of laws, the legal registration of the pharmacy business begins with the reforms of Peter I, who systematically approached the legal framework of pharmacy as a separate area of medicine^[1].

The first regulatory legal act related to the field of pharmacy and reflected in the Full Collection of laws is the Nominal Decree "On customs inspection of supplies brought for the Pharmacy Order", dated 1693^[18], which states to write in books and put seals on all imported medicines, alcoholic beverages and medicinal materials in order to turnover control. The further development of the formation in the field of legal registration and the intensity of the legislative activity of the monarchs was reported from this normative legal act.

The complete collection of laws for the period from 1649 to 1825 includes 137 normative legal acts regulating the field of pharmacy. The distribution by the periods of the reign of the Russian rulers is as follows (see diagram 1)

Diagram 1. – Quantitative distribution of regulatory legal acts in the field of pharmacy by the periods of the reign of Russian rulers from the end of the XVII to the first quarter of the XIX centuries.From the diagram above, we can conclude about the activity of the rulemaking of the Russian rulers in this direction.

Thus, the largest number of normative acts were issued under Alexander I, which is a general reflection of the legislative activity of the emperor^[5]. The low rule-making activity of Catherine I and Peter III is natural due to the short-term nature of their boards. Noteworthy is the activity of Catherine II in an effort to regulate pharmacy, which, it seems to us, is a natural component of the general leap in the development of medicine during the reign of the enlightened monarch^[11]. However , the general trend was set by Peter I.

Quantitative analysis gives only a general idea of the legislative activity of the rulers in the field of pharmacy. Let us turn to the consideration of the subjects of regulation (see Table 1).

Table 1. – Distribution of subjects of regulation of normative legal acts by periods of the reign of Russian rulers.Based on the summary table, it can be stated that most often legislators in the field of pharmacy sought to regulate the sphere of personnel: training, maintenance, career opportunities.

Thus, 43 out of 147 (several regulatory legal acts (NPA) have identified several subjects of regulation) relate to the subject of personnel policy. Alexander I (20 NPAs) dealt with personnel issues in quantitative terms most of all. Regulatory legal acts regulating this area account for 40% of all laws issued under this ruler regulating the pharmaceutical industry. The next most important direction is the control over the turnover of medicines and materials, this direction was regulated during the specified period by 23 NPAs.

It is noteworthy that a number of the documents under consideration are duplicates or confirmatory. So, for example, from the list you can select 3 NPA regulating the sale of toxic substances, in particular arsenic. In 1731, under Anna Ioannovna, a Nominal decree was issued "On non-sale and incontinence in arsenic shops, except pharmacies"^[21], followed by a Nominal decree in 1733 "On the prohibition of selling arsenic and all kinds of poisonous materials in rows, in shops and on Torzhki and on punishing those who are in such an impermissible sale he will be found guilty"^[23]. The decree of 1733 is an addition and extension of the decree of 1733: the list of toxic substances is expanded, and the customs office as a place of sale of toxic substances is replaced by a Town Hall, letters and notes are canceled as the basis for the sale of arsenic. The next similar NPA was published in 1758 under Elizabeth Petrovna "On the sale of poisonous materials from Pharmacies and Town Halls alone, on the collection of fines from those guilty of illegal sale thereof, and on the awarding of informers"^[12]. In fact, the last NPA is confirming the decree of 1733 and tightening sanctions for the sale. Apparently, the decree of 1733 was not executed properly, as it provided for a rather mild punishment in case of fatal consequences of the sale of toxic substances ^[33]. In addition to restricting the sale of poisons, there were other duplicate NPA in the considered list of NPA. So, for example, the Nominal decree of 1783 "On the compilation of medicines in all accuracy according to the prescriptions of Doctors and Healers sent to Pharmacies"^[13] according to the content and spirit with the Nominal Decree of 1795 "On confirmation to doctors who have practice, so that prescriptions are written with all possible care, clearly and intelligibly, and to pharmacists, so that in the preparation of medicines they observe the accuracy of what is prescribed in prescriptions and conform to the tax when on vacation"^[14]. However, in this case, the decree is already confirmatory, so it extends the validity of the NPA and once again focuses attention on the problem.

In the Complete collection of laws of the Russian Empire in the direction of pharmacy, it is clearly possible to draw a line between military and civilian. In addition, since the Petrovsky period, free and state-owned civilian pharmacies have appeared, which is clearly reflected in the NPA.

Legislators also paid great attention to customs clearance of imported medicines and materials. One of them is the previously considered Nominal Decree "On the customs inspection of supplies brought for the Pharmacy Order"^[19] of 1693, which introduces inspection for imported supplies, but already in 1732, by the Nominal decree of Anna Ioannovna, this norm ceases to apply, a Decree is introduced "On the admission without inspection of pharmacy supplies brought from overseas to the Moscow and Astrakhan pharmacies, with the application of the seal and the taking of these registers and the inspection of these for the suit of importation"^[22]. Apparently, this caused a number of problems related to the quality of supplies supplied, in connection with which, after 2 years, the Highest Resolution of 1734 appears "On the inspection of pharmacy materials and supplies brought from overseas to state pharmacies from the Port Customs at those pharmacies, on non-collection of duties from them and on Making this into the Customs The Charter"^[24]. This norm was in effect until 1797, when Paul I issued a Personal Decree "On the import of pharmacy materials"^[15]. Subsequently, until the end of the reign of Alexander I, the rules for the import of medicines and materials to Russia did not change.

Speaking about the forms of normative legal acts issued by the rulers during the period under review, it can be stated that there are 20 of them for the field of pharmacy (see Table 2.)

Table 2. – Distribution of forms of normative legal acts by periods of the reign of Russian rulers.The most popular forms of pharmacy regulation during the period under review were nominal decrees (44) and Senate decrees (37), the most highly approved report (18).

These 3 forms account for 72% of all regulatory legal acts in the field of pharmacy from the second half of the XVII to the first quarter of the XIX centuries. The rationale for this distribution is quite simple. The most frequently used form of the NPA for the period under review is a nominal decree, that is, a decree emanating from the sovereign emperor and personally signed by him. Senate decrees since the time of Peter I, who created it, have been one of the key forms of law-making. The most highly approved report is a form that appeared with the creation of the Committee of Ministers under Alexander I, through which the bulk of regulatory legal acts passed.

One of the most important NPAs in the pharmaceutical industry was and still is the State Pharmacopoeia – a set of mandatory rules that guide the manufacture, inspection, storage and registration of medicines for patients. Until the second half of the XVIII century, doctors and pharmacists of the Russian Empire were guided by the rules of various European countries due to the lack of a domestic legislative analogue. With the accumulation of knowledge and experience, doctors and pharmacists increasingly faced the question of creating a Russian Pharmacopoeia. By the decree of Catherine II in 1763, instead of the Medical Office, a Medical College was established, the main task of which was to create a national pharmacopoeia. Thus, in 1765, the institution issued the "Military Pharmacopoeia", and only in 1802 – the general "Russian Pharmacopoeia"^[8].

Among the forms of the NPA, the Apothecary's Charter of 1789 can be singled out separately, created by order of Catherine II under the leadership of I. F. von Fitingoff "Evaluation of medicines, moreover: The Apothecary's Charter. The charter of midwives. The Charter on due payment to medical ranks" ^[16].

At its core, this Charter is a codification of all previously issued laws regulating the activities of pharmacies. Thus, the Charter clearly regulated the position of the pharmacist and the personnel of pharmacies, the activities of the pharmacy police and the pharmacy fee. It is noteworthy that in the Complete Collection of laws up to 1825 there are no NPAs amending this Statute^[27].  

Separately, it is necessary to note the NPAs, which are of a casuistic nature, but published at the highest level. For example, the Senate decree of 1733 "On preventing the students of the Moscow State Capital from collecting herbs and roots and catching leeches in the Moscow province"^[25]. Apparently, the scale of the "hindrances" to collect the above-mentioned students has reached a level when the Senate needed to settle it. Similar is the nominal decree of 1809 "On the prohibition of Pharmacy students and workers to collect plants on serf verks"^[21]. In all likelihood, the students by their actions caused significant harm to the serfs by trampling fields and mass harvesting of plants.

The most important component of the legal regulation of pharmacy in the second half of the XVII – first quarter of the XIX century was the military component. Thus, 37 of the 137 cited NPAs were aimed at regulating military pharmacies. Among other NPAs, there were decrees regulating the purchase of medicines in military pharmacies by military personnel. For example, the decree of the military College of 1807 "On non-demand from state pharmacies, without money, according to prescriptions for Staff and Chief Officers of wine alcohol, nutmegs and fragrant oils" ^[17]. Military pharmacies undergo multiple changes in connection with the Napoleonic Wars. So, from 1810 to 1812, the rules for manning regiments with pharmacies were changed, a decree was issued changing the samples of pharmacy regimental boxes, infirmary items, regulations were issued on supplying a large active Army with medicines for the duration of the war, which would later retain its legal force, the positions of field pharmacists were introduced in wartime, rules for the arrangement and management of pharmacy stores in wartime. All this speaks of the mobilization of pharmacy in Russia, initiated by the Emperor, for the transformation of the Russian army in the field of medicine and pharmacy in accordance with best practices.

Based on the data presented in the study, it can be concluded that pharmacy was an important component of legislative activity in the field of legal regulation of healthcare. It is also worth noting the presence in the legislation of the period under review of a longitudinal tendency for the state to take over the functions of social protection of the population and the withdrawal of both pharmacy and professional medicine as a whole from a narrow court environment to a public one. The areas of regulation within pharmacy during the period under review cover a wide range: from military pharmacies to determining the behavior of pharmacy students. The formation of pharmacy in Russia has largely developed, as legal sources show, thanks to the imperative norms of the supreme power.