The factors influencing the state of Poland’s pharmaceutical industry were investigated using the PESTEL tool, which considers political, economic, social, technological, ecological and legal factors. The findings of the author’s research indicate that the greatest impact on the development of the pharmaceutical sector is currently being made by changes in law and technology (Table 1), and this is likely to remain the case for the near future. The regulatory framework applies to all actors and processes involved in the Polish pharmaceutical sector’s supply chain. Given the health hazards that its products may pose, it comes as a matter of fact that the industry is commonly regulated, with stringent and detailed rules imposed at all stages—from production to delivery to end consumers (patients). Industry-specific rules regulate not only the production and sales of drugs, but of dietary supplements and cosmetics as well. Further, there are by-laws that can also immediately affect the market pertaining to the circulation of such products, involving the POM reimbursement regime or permits issued to specific businesses or types of businesses. Poland’s pharmaceutical sector is essentially governed by the Act of September 6, 2001, Pharmaceutical Law (further in this chapter referred to as “UPF”) (Journal of Laws, 2008, No. 45, item 271, as later amended). The law lays down the following: rules and procedures for the sale of medicinal products, regulations for the conduct of clinical research and the making of medicinal products, requirements to be met by pharmacies, pharmaceutical wholesalers, and non-pharmacy channels (outlets), organization of the system for control and assurance of medical product safety, terms of reference for Pharmaceutical Inspections, standards for the advertising of medicinal products. At the same time, national legislation governing the pharmaceutical sector must be regularly reviewed and amended for compliance with EU regulations. The blend of EU regulatory influence, the goals of government social policy, and the recurrent government budget process make the sector extremely vulnerable to legislative changes that can have an immediate impact on its profitability as a whole or at least of some of its segments. The detailed requirements to be met in running a pharmacy business are set out in the Regulation by the Minister of Health of September 30, 2002. Polish, as well European, legislation also addresses a very broad range of aspects involved in wholesaling, specifying the detailed responsibilities of a pharmaceutical wholesaler (PwC 2013). The sale and advertising of pharmaceuticals is subject to supervision by the Main Pharmaceutical Inspectorate [Główny Inspektorat Farmaceutyczny—GIF]. At the same time, a medicine may not be marketed over-the-counter unless permission is granted by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products [Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych—URLP]. Other important actors in Poland’s pharmaceutical market include: the Polish Chamber of Physicians and Dentists [Naczelna Izba Lekarska], the Polish Pharmaceutical Chamber [Naczelna Izba Aptekarska], the Polish Chamber of the Pharmaceutical Industry and Medical Products POLFARMED [Polska Izba Przemysłu Farmaceutycznego i Wyrobów Medycznych POLFARMED], and the Polish Association of the Self-Medication Industry [Polskie Stowarzyszenie Producentów Leków Dostępnych bez Recepty—PASMI]. The so called “Reimbursement Law”—the Act of May 12, 2011 on Reimbursement for the Purchase of Medicines, Special Purpose Foods, and Medical Products (Journal of Laws, 2011, No. 122, item 696)—came into force on January 1, 2012. The law introduced new rules for the reimbursement of pharmaceutical purchases, including regulated prices and margins for publicly funded medicines as well as restrictions on pharmacy advertising. The pharmaceutical law does not allow drug manufacturers to target advertisements for prescription-only medicines directly at patients, while it is possible to target these at physicians. Then law became more strict at the beginning of 2012 when a complete ban on advertising by pharmacies came into effect. The issue of Internet advertising for OTC drugs closely parallels that of alcohol advertising. Since the legislation does not address the new online medium directly, there are no explicit guidelines, such as those governing TV or radio commercials. This leaves much room for interpretation. As a result, regulations intended for other media are applied but prove inadequate or unintelligible in the context. Practices are therefore diverse, with each company endeavoring to do online whatever their law departments or firms deem acceptable (Loedl 2015). An area that appears critical to the growth of online pharmacies is legislation on e-health, for example, on electronic prescribing. At the end of 2015, there were ten European countries that had already had some experience with e-prescriptions for reimbursable medicines, but Poland was not among them, thus there was an absence of legislation and links between the health care system and pharmacies. A concern that has just recently afflicted the pharmaceutical market is that of parallel exports—a term denoting uncontrolled flow of pharmaceutical products to countries where they can be sold at a considerably higher price, resulting in a shortage of medicines in Poland. To mitigate the problem, on May 7, 2015 amendments were enacted to the UPF law. The amendments require companies to report their stock levels and sales figures daily, and impose an obligation to inform the pharmaceutical inspection authority of any intent to export pharmaceuticals (UOKIK 2015). In parallel, EU member states are working on regulations to prevent drug forgery, and Poland is not an exception here. Technology advances constitute another major group of factors influencing the leadership development goals examples of the pharmaceutical industry. Advances in genetics, biotechnology, nanotechnology, and other sciences will remain key drivers of growth in the sector. Simultaneously, the Internet revolution has triggered the emergence of e-commerce as a new drug marketing and distribution channel, including access via mobile devices, such as smartphones. In Poland, between 2004 and 2014, the total e-commerce market increased from PLN 2 bn to PLN 29 bn (interaktywnie.com 2015). According to the Centre for Retail Research, in 2015, online sales represented 3.3% of retail sales nationwide. This is still below the average for other European countries, where e-commerce contributes 8.4% of total sales (and at the higher end: 11.6% in Germany and 15.2% in the UK). However, the e-commerce segment of Poland’s market is now catching up very quickly. Since 2010, its growth has run at an impressive two-digit rate, and is commonly believed to have further growth potential. In 2014, Poland was ranked 24th among the 30 European countries covered by the PI Research (2016) in terms of the expansion of e-commerce, primarily because most Polish customers continued to refrain from buying online. In a survey focused on the e-commerce sector and conducted at the request of the Chamber of Digital Economy [Izba Gospodarki Elektronicznej] only 55% of Polish Internet users admitted to having hands-on experience of online purchases. In terms of private sector digital services, digital competences of staff, and the quality of e-government, Poland stands as low as 28th place in the PI ranking. At the same time, it is one of the fastest countries to catch up across Europe (PI Research 2016). The key economic factors are the following: GDP growth rate, inflation rate, average personal income, policy toward parallel trade, drug prices, and drug reimbursement rate. Prior to 2010, the pharmaceutical sector showed growth dynamics exceeding the annual GDP growth rate (Fig. 1). A decline in the sector’s financial indicators was observed in 2011–2012 and was associated with changes in the drug reimbursement regime. Its condition improved in 2013–2015. A social factors on which the development of the pharmaceutical sector is contingent are demographics, including population breakdown by sex, age, residence, as well as average life expectancy. In the future, Poland is going to increasingly see the overlapping of two trends: the average lifespan becoming longer on the one hand, and the ageing of society on the other. Compared to mid-twentieth century, the average life expectancy in Poland is 17–20 years longer, depending on sex, approximately 74 for men and 82 for women. Furthermore, elderly persons represent a larger proportion of society each year. It is estimated that, in 2035, 23% of Polish people will be above 65 years. In 2050, every third Pole will be above that age. Surveys performed by GUS show that each year is marked with an increase in the number of patients suffering from chronic diseases. The prevalence of hypertension grows at a rate of 2%, and of diabetes—at 2.5% annually. Cardiovascular diseases account for nearly 27% of deaths below the age of 65 and for 24% of work disabilities. These factors obviously incur significant medical, social, and economic costs. More than 76% of Polish people use drugs and dietary supplements, of which 40% take painkillers; nearly 40% of the adult population do not use the services of physicians, half of whom indicate time constraints as the main reason, while the other half—long waiting-times for healthcare services. This means that this social group purchases OTC medicines. Opineo.pl has established that Poles take four pills per day on average. The French are the only nation across Europe to surpass Poles in their dependence on medicines. Among political factors, it is the incumbent government’s decisions that make the greatest impact on the pharmaceutical industry, such as those on the future evolution trajectory of the healthcare system, including the public health insurance fund (NFZ). In addition, the Polish government has to implement regulations defined at the EU level. As with other economic sectors, the pharmaceutical industry must make more effort to conform to natural environment protection regulations and requirements. At the same time, specific weather conditions or changes of seasons tend to have adverse effects on health, causing illnesses and complaints and hence boosting demand for medication. There is also the issue of waste, unused and dumped out-of-date medicines, as well as disposal of pharmaceuticals returned to pharmacies requiring the management of reverse flows.
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