Thesis (MBA)--Stellenbosch University, 2011. / This study analyses the effects of generic medicine competition on the market share growth and pricing of originator brand medicine in the South African private pharmaceutical market. The study is based on five years (2005 to 2011) of IMS Health market share data for 39 originator brand drugs that have been exposed to competition from generic substitutes from 2001. The results show that, for all the drug molecules included in the study pooled together, the price of an originator brand medicine relative to the weighted average price of its generics has a significant negative impact on the change of its market share. Results for the molecules pooled according to anatomical classes, as well as each molecule separately, show that in four out of the nine classes represented in the study and nine out of the 39 molecules the relative price of the originator brand medicine had a significant negative impact on its change in market share. The manufacturers and marketers of generic medicines would be well advised to offer their medicines at significantly discounted prices compared to the originator brands, as the results suggest that the market penetration of the generic product may depend heavily on the price the generics are offered at. Investigations into the prices of the originator brands in relation with the number of generic equivalents in the market show that the number of generics available in a specific market has a significant positive impact on the relative price of originators, thereby making originators relatively more expensive compared with their generic competitors, while at the same time the results show that the absolute price of the originator brand medicines declines as the number of generic equivalents in the market increases. This indicates that, from a policy perspective, reducing the barriers to entry for generic medicine once originator patents expire may have a significant role to play in reducing the cost of pharmaceutical drugs in the South African market.

Introduction: Due to the increase in healthcare costs, generic medicines have been adopted for used in both developed and developing countries. When a generic or ‘multisource interchangeable medicine’ is to be registered, studies that prove that the generic is equivalent to the Innovator Product (IP) are used. The generic medicine is required to prove that it will mirror the IP in terms of safety, quality and efficacy and, in South Africa, the Medicines Control Council (MCC) ensures that generic medicines meet these requirements. Generic medicines may be registered using bioequivalence data obtained from comparison with a domestic reference product (usually the local innovator product) or in certain cases, a foreign reference product (FRP). The bioequivalence data can either be from in vivo or in vitro studies. The MCC guidelines require that for modified release preparations, in vivo bioequivalence studies are done for approval of registration; the exception being if a proportionally higher dose has already been registered. No information is currently given to prescribers and dispensers or to the public about whether a generic product was registered against a foreign or domestic reference product. Aims and Objectives: 1.) To determine the number of generic medicines in a predetermined sample registered using a FRP as comparator and to document the transparency of pharmaceutical companies when approached to disclose information regarding the registration of these products. 2.) To describe and document the use of the Promotion of Access to Information Act (Act 2 of 2000) [PAIA] from the perspective of a ‘layperson’ in the context of medicines’ regulation, in both private and public bodies. Methods: 20 modified release and Biopharmaceutics Classification System (BCS) class IV products were selected from the ‘generics dictionary’ – a commercial publication – and letters were sent to the manufacturers of the products requesting information about the tests done to prove equivalence and whether they were performed against a domestic or foreign reference product. The same information was also requested from the MCC. The requests were all made using the Promotion of Access to Information Act (PAIA). Results: Nine companies were represented by the 20 products chosen. Information was obtained about thirteen products. Ten of these products were registered using FRPs. Four products were registered based only on comparative dissolution studies. Four companies provided the requested information, two companies responded by refusing the requests and three did not respond at all. The MCC refused the request for information even after an internal appeal was lodged. Conclusions: The Promotion of Access to information Act was unsuccessful in obtaining information from the public body, and partly successful in obtaining it from the private bodies. While the title of the Act seems to indicate that the Act can be used to obtain information as such, it only provides for access to specified records. The MCC and the pharmaceutical companies involved in the study were under no obligation to provide the information as the request had not complied with PAIA requirements. The use of FRPs for registration is a reality in the pharmaceutical industry in South Africa. Neither the public nor healthcare professionals who prescribe medicines or who are involved in dispensing generic medicines as substitutes are aware of whether or not a FRP has been used to register a generic. Interchangeability cannot necessarily be guaranteed if the reference product was not proven equivalent to the local innovator product. It is debatable as to whether or not this information would be of any particular benefit to members of the public. Prescribers may choose to write ‘no substitution’ on their prescriptions if they were unconvinced that an FRP is acceptable. This could have consequences for healthcare costs. Dispensers are the most vulnerable in South Africa as they are obliged by law to substitute generic medicines when innovator medicines have been prescribed. Dispensers’ views on the acceptability of the use of FRPs can be seen as irrelevant. In the end, as this study demonstrates, the only option in the present situation is to rely entirely on the MCC’s rigour in assessing applications for registration of generic medicines.

Thesis (MBA)--Stellenbosch University, 2000. / ENGLISH ABSTRACT: This study is essentially an investigation into perceptions that exist in the medical field with regards to generic medicines and generic substitution. The study was conducted via the sampling of a variety of physicians, specialists and pharmacists in the Cape Peninsula. The primary test for these perceptions was the application of a five page questionnaire that the targeted sample group had to complete. South Africa entered a new era on political, social and economic levels with the election of a new democratic government. The reality is that South Africa is becoming more and more a third world country with deteriorating systems of health care and education, as a direct result of a shortage of funds and inadequate management or total lack thereof. It has also become more and more evident recently that this country is experiencing a "brain-drain", in that experienced and highly qualified people are leaving the country for mostly other first world countries, because they can no longer operate efficiently and effectively under the constraints imposed upon them by a shrinking health care budget. Government and private health departments constantly have to face the battle of containing costs so that they can operate in the way that they are supposed to. Unfortunately, with the constant escalation in the prices of medicine every year combined with a limited availability of funds, the problem just becomes worse every day with patients and medical aids suffering the most. One possible way in which an attempt could be made to reduce costs is to decrease the expenses of medicine, making more money available in other areas, or that the need for more medicines could be satisfied via having more money available as a result of these savings. Generic medicines are known to be less expensive than their ethical counterparts and can therefore contribute greatly to savings in this area, seeing that generic medicines mostly sell at 40%-50% of the price of the original. There are obviously more issues involved than just costs: the ethical issue of moral support to the ethical manufacturers that have done all the research and development of the original drug that now becomes "copied"; the issue of.quality and reliability of these "copycat" medicines; and the issue of the role that people in the medical field, government and other bodies should play in containing costs. These issues were addressed in the form of statements in the questionnaire and opinions were tested to see what perceptions exist, so that the marketers of medicines would know how to formulate their marketing plans and strategies in order to attain a bigger market share, or how to protect their current share of the market. The information should also prove handy to government and private health care organisations that should endeavour to contain costs wherever they can, seeing that they operate within the constraint of an allocated budget. / AFRIKAANSE OPSOMMING: Hierdie studie projek is essensieel 'n ondersoek na persepsies wat bestaan in die mediese veld met betrekking tot generiese medisynes en generiese plaasvervanging. Vir die doel van die studie is "mediese veld" gedefinieer as die verskillende kategorieë van mediese dokters en aptekers wat elke dag met die vraagstuk te make het. Die steekproef was dus mediese dokters, spesialiste en aptekers in die Kaapse Skiereiland. Die primere toetsinstrument was 'n vyf-bladsy vraelys wat 35 stellings bevat het waarin 8 faktore verskans was waarvoor die navorser getoets het. Suid-Afrika het 'n nuwe era betree met die daarstelling en verkiesing van 'n nuwe demokratiese regering van nasionale eenheid waarin alle Suid-Afrikaners deelname het. Die realiteite van Suid-Afrika vandag is dat dit meer en meer sy derde wêreld komponente openbaar waarvan die bestaan vantevore deur die eerste wêreld komponent geïgnoreer is. Die resultaat is dat gesondheidsorg en opvoedkundige sisteme aan die verkrummel is vanweë 'n tekort aan fondse asook oneffektiewe bestuur. Dit is dan ook onvermydelik dat 'n groot aantalleiers en kenners op hierdie gebiede besluit om die land te verlaat en na hoofsaaklik eerste wêreld lande emigreer, waar hulle in 'n veel mindere mate te kampe het met die probleme van swak bestuur en veral onder befondsing in die onderskeie areas van hulle spesialiteit. Dit laat 'n gaping wat gevul moet word deur swakker bestuur wat die probleem vererger. Regering- en privaat mediese departemente gaan gebuk onder die las van krimpende begrotings en 'n stygende vraag na mediese sorg, medisynes en ander geriewe. Dit is ook 'n voldonge feit dat mediese tariewe bly styg, dat medisynes konstant al hoe duurder word en dat daagliks waargeneem word dat daar 'n ondervoorsiening van personeel en medikasie in hospitale en ander gesondheidsorganisasies is. Die partye wat aan die kortste end trek is die pasient en die mediese fondse. Een moontlike wyse waarop hierdie probleem van stygende kostes aangespreek kan word is om die uitgawes op medisynes te beperk sonder om minder medisynes te koop, sodat meer geld beskikbaar sal wees vir ander behoeftes. Dit is bekend dat generiese medisynes heelwat goedkoper is as hulle etiese "broers" en dat die gebruikmaking hiervan kan lei tot besparings so groot as selfs 60% en meer. Daar is duidelik meer vraagstukke betrokke rondom die hele aangeleentheid van generiese medisynes en generiese plaasvervanging soos: die etiese vraagstuk aangaande morele ondersteuning aan die etiese firmas wat al die navorsing en ontwikkeling van die oorspronklike produkte doen en wat nou net gedupliseer word deur die generiese vervaardigers; die vraagstuk aangaande die betroubaarheid en kwaliteit van hierdie "duplikate"; asook die vraagstuk rondom die rol wat persone in die mediese veld en regerings- en- privaatinstansies moet vervul in die bekamping van stygende kostes. Hierdie vraagstukke is geadresseer in die vraelyste as stellings en opinies is getoets om vas te stel wat die huidige persepsies rondom die aangeleentheid van generiese produkte en generiese plaasvervanging is. Die belang van die kennis van hierdie opinies en persepsies is dat dit onontbeerlike inligting verskaf aan die bemarkers van farmaseutiese produkte en medisynes aangesien 'n bemarkingsplan en bemarkingstrategie hier rondom gevorm kan word, sodat maniere uitgewerk kan word om markaandeel te vergroot of om markaandeel te behou.

Σήμερα η επιστήμη υπόσχεται νέες ανακαλύψεις που θα μας επιτρέπουν να ζούμε όχι μόνο περισσότερο αλλά και καλύτερα. Πρωτεύοντα ρόλο σε αυτή τη διαπίστωση κατέχει η φαρμακοβιομηχανία, όπου μέσω της συνεχούς έρευνας και ανάπτυξης παράγει νέα, καινοτόμα, πρωτότυπα φάρμακα. Τα πρωτότυπα φάρμακα εξακολουθούν να κατέχουν ηγετική θέση στην παγκόσμια φαρμακευτική αγορά, παρόλο που μετά τη λήξη της πατέντας τους δέχονται έντονες πιέσεις από την παραγωγή των αντίστοιχων γενοσήμων φαρμάκων. Είναι απαραίτητο να τονιστεί ο σημαντικός ρόλος των πρωτοτύπων στην προστασία της δημόσιας υγείας, όταν μάλιστα στην ελληνική αγορά έχουν εισέλθει μια πλειάδα γενόσημων φαρμάκων, υπό το μανδύα της οικονομικής κρίσης και της περιστολής των φαρμακευτικών δαπανών. Μέσα σε αυτό το πλαίσιο, η παρούσα διπλωματική εργασία προσπαθεί να αναζητήσει τους λόγους και τα κίνητρα της συνταγογράφησης των πρωτότυπων φαρμάκων από τους Έλληνες γιατρούς, μέσα σε ένα ταραχώδες συνεχώς μεταβαλλόμενο εξωτερικό περιβάλλον. Ουσιαστικά λοιπόν αναζητήσαμε ποιοι είναι αυτοί οι παράγοντες που κάνουν τους γιατρούς να συνταγογραφούν τα πρωτότυπα φάρμακα και πως αυτοί σχετίζονται με μια σειρά εξωτερικών παραγόντων. Τα ευρήματα της μελέτης προέκυψαν από τις απαντήσεις που έδωσαν 83 γιατροί διαφόρων ειδικοτήτων. Για την επιλογή των γιατρών δόθηκε έμφαση στη συμμετοχή ειδικοτήτων που έχουν υψηλή συνταγογράφηση, με κύριες ειδικότητες τους παθολόγους και τους ορθοπεδικούς. Η έρευνα πραγματοποιήθηκε σε γιατρούς των περιοχών των νομών Αχαΐας, Ηλείας και Κεφαλονιάς. Τα σημαντικότερα συμπεράσματα που προέκυψαν μετά τη στατιστική ανάλυση των απαντήσεων που δόθηκαν ήταν: 1) η πολύ μεγάλη αποδοχή που εξακολουθούν να έχουν τα πρωτότυπα φάρμακα από την ελληνική ιατρική κοινότητα, ακόμα και όταν υπάρχουν αντίστοιχα γενόσημα, 2) το ευρύτερο πλαίσιο των παραγόντων που επηρεάζουν τη συνταγογραφία των γιατρών είναι: α) η αποτελεσματικότητα, β) το κύρος/όνομα της φαρμακευτικής εταιρίας, γ) η τιμή του φαρμάκου, δ) η καινοτομία, ε) η ασφάλεια/ανεπιθύμητες ενέργειες, 3) οι εταιρίες με πρωτότυπα φάρμακα επηρεάζουν τη συνταγογραφία των γιατρών ανάλογα με το κύρος και το όνομά τους, 4) η άσχημη οικονομική κατάσταση που επικρατεί στη χώρα καθώς και τα μέτρα που έχουν ληφθεί στο χώρο της υγείας, δείχνουν να στρέφουν κάποιους γιατρούς από τα πρωτότυπα προς τα γενόσημα, 5) οι «διαμορφωτές γνώμης» επηρεάζουν σχετικά τη συνταγογραφία των Ελλήνων γιατρών, μόνο όμως όταν εμφανίζονται σε συνέδρια και συμπόσια ως ανεξάρτητοι επιστήμονες, ενώ δεν την επηρεάζουν καθόλου ως προσκεκλημένοι ομιλητές σε εταιρικές εκδηλώσεις, 6) οι πρακτικές marketing των εταιριών με πρωτότυπα υπερτερούν από τις αντίστοιχες των εταιριών με γενόσημα, 7) ο ιατρικός επισκέπτης επηρεάζει θετικά τη συνταγογραφία των γιατρών όταν είναι καλά ενημερωμένος για το φάρμακό του, 8) παρατηρείται τάση των γιατρών για χαμηλό ρίσκο στη συνταγογράφηση, 9) τα γενόσημα φάρμακα είναι πολύ πιο πιθανό να συνταγογραφηθούν σε αδύναμες οικονομικά και κοινωνικά ομάδες. Συμπερασματικά θα μπορούσαμε να πούμε πως οι Έλληνες γιατροί εξακολουθούν να εμπιστεύονται τόσο τα πρωτότυπα φάρμακα που προστατεύονται με πατέντα, όσο και τα πρωτότυπα εκτός πατέντας φαρμακευτικά σκευάσματα (σκευάσματα δηλαδή τα οποία αν και κυκλοφόρησαν ως πρωτότυπα έχουν απολέσει την προστασία της πατέντας τους). Παρόλο όμως που θεωρούν τα προαναφερθέντα φάρμακα αποτελεσματικά και αξιόπιστα, μια σειρά από εξωτερικούς παράγοντες τους δημιουργεί την τάση να κινηθούν προς την κατεύθυνση των γενοσήμων, περισσότερο από ότι στο πρόσφατο παρελθόν. / Today science promises new discoveries that will allow us to live not only longer but also better. The pharmaceutical industry plays a leading role to this fact where through continuous research and development, new, innovative, brand named drugs are produced. Brand named drugs continue to hold the leading place in the global pharmaceutical market, although after the expiration of their patent they face severe pressure from the production of their counterparts, generic drugs. It is essential to emphasize the important role that brand named drugs have to the protection of the public health, even though at the same time many unknown generic drugs have entered the Greek pharmaceutical market under the justification of the financial crisis and the containment of pharmaceutical expenditures. Under this prism, the present thesis tries to determine the reasons and the motivations of Greek physicians for prescribing brand names drugs, within a turbulent and constantly changing external environment. Our basic purpose was to discover the factors that make the physicians prescribebrand named drugs and how these factors were related with a number of external factors. The findings of this thesis are derived from the answers given by 83 doctors of different specialties. The specialties were those that have high prescription capability, with pathologists and orthopedics being the two most numerous specialties. The research was conducted with the participation of doctors from the counties of Achaia, Ilia and Cephalonia. The most important findings that came up after the statistical analysis of the answers given were: 1) The great acceptance that brand named drugs still have from the Greek medical community, even when their counterpart generics exist in the market 2) The main factors that influence the doctors prescriptions are: a) the efficacy of the medicine b) the prestige / name of the pharmaceutical company c) the price of the medicine d) the innovation of the medicine e) the safety / side effects 3) The pharmaceutical companies that produce brand named drugs influence the doctors prescriptions by their prestige and good name 4) The financial crisis in Greece and the measures that have been taken by the state for reducing the pharmaceutical expenditures seem to influence some doctors to prescribe more generics than they did in the past 5) “Opinion leaders” influence the prescription attitude of the Greek doctors only when they appear to congresses and forums as “independent” scientists. On the other hand they seem not to influence at all when they appear as speakers to any corporate event sponsored by a pharmaceutical company 6) Marketing practices of companies producing brand named drugs seem to be more effective than those that produce generic drugs 7) A medical representative that is well educated about his drug positively influences the prescription habits of the doctors 8) It is observed a tendency of doctors for taking low risk when they prescribe madicines to their patients 9) Generic drugs are more likely to be prescribed to low income and low social status groups of the population. In conclusion we can say that Greek doctors still trust not only the brand named drugs protected under patent, but also the off patent brand name drugs (brand named drugs that their patent has expired). Although they consider the aferementioned drugs effective and reliable, a number of external factors create a tendency for them to prescribe now more generic drugs than they used to prescribe in the recent past.

Στην Ελλάδα ο όρος “γενόσημα” φάρμακα έχει γίνει ευρέως γνωστός τον τελευταίο καιρό, παρ’ό,τι στην Ευρώπη και σε άλλες χώρες του κόσμου η χρήση γενοσήμων είναι γνωστή εδώ και δεκαετίες. Η παρούσα διπλωματική εργασία έχει σκοπό να μελετήσει τους παράγοντες που επηρεάζουν τη στάση ασθενών-καταναλωτών και επαγγελματιών υγείας ως προς τα γενόσημα φάρμακα. Πιο συγκεκριμένα, μελετώνται διάφοροι παράγοντες που βρέθηκαν μέσα από τη βιβλιογραφική ανασκόπηση ότι επηρεάζουν τις πεποιθήσεις των ασθενών-καταναλωτών και των επαγγελματιών υγείας. Αρχικά, έγινε μια βιβλιογραφική ανασκόπηση σε μελέτες της διεθνούς βιβλιογραφίας σχετικά με το θέμα των γενόσημων φαρμάκων. Στη συνέχεια, κατασκευάστηκαν δύο ερωτηματολόγια, ένα που απευθυνόταν σε ασθενείς-καταναλωτές και ένα που απευθυνόταν σε επαγγελματίες υγείας. Το πρώτο ερωτηματολόγιο συμπλήρωσαν 364 ασθενείς-καταναλωτές. Το δεύτερο συμπλήρωσαν 95 επαγγελματίες υγείας (ιατροί και φαρμακοποιοί). Τα στοιχεία που συλλέχθηκαν από τα ερωτηματολόγια αναλύθηκαν στη συνέχεια με τη βοήθεια του προγράμματος SPSS. Από τις αναλύσεις που έγιναν, διαπιστώσαμε πως στους περισσότερους πλέον ασθενείς ο όρος «γενόσημα φάρμακα» είναι γνώριμος αλλά, υπάρχει έλλειψη σωστής πληροφόρησης. Παρόλα αυτά, οι μισοί σχεδόν ασθενείς έχουν θετική στάση προς τα γενόσημα φάρμακα και είναι διατεθειμένοι να τα χρησιμοποιήσουν μετά από σύσταση του ιατρού κυρίως, ή και του φαρμακοποιού. Επίσης, οι πιο σημαντικοί λόγοι που τους ωθούν να αγοράσουν ένα φάρμακο είναι η ασφάλεια και η αποτελεσματικότητά του. Από τις αναλύσεις των απαντήσεων των επαγγελματιών υγείας διαπιστώσαμε πως υπάρχει έλλειψη γνώσεων και σωστής πληροφόρησης. Ενώ είναι πρόθυμοι να συνταγογραφήσουν/χορηγήσουν γενόσημα φάρμακα, παρόλα αυτά, προτιμάται η χρήση πρωτότυπων φαρμακευτικών σκευασμάτων, πιθανότατα λόγω της έλλειψης εμπιστοσύνης προς τον ΕΟΦ. Πιστεύεται πως η βελτίωση της αξιοπιστίας του Οργανισμού και η καλύτερη ενημέρωση των επαγγελματιών υγείας θα συμβάλει στην αύξηση χρήσης των γενοσήμων. Το κράτος έχει θεσπίσει ήδη αρκετά μέτρα για την αύξηση χρήσης των γενοσήμων. Προτείνεται όμως, να γίνει μια πιο ολοκληρωμένη προσπάθεια μέσα από τα κανάλια των επαγγελματιών υγείας, της φαρμακευτικής βιομηχανίας αλλά και των ασθενών-καταναλωτών, ώστε να αποδώσει η προσπάθεια αυτή και επιτευχθεί ο σκοπός της. / In Greece the term "generic" drugs has become widely known lately, although in Europe and other countries of the world, generics are known for decades. This thesis aims to study the factors that affect the attitude of patients-consumers and health professionals to generics. More specifically, it examines various factors found through the literature to influence the beliefs of patients, consumers and healthcare professionals. Initially, there was a literature review on studies of the literature on the subject of generic drugs. Then, we constructed two questionnaires, one aimed at patients-consumers and one that was aimed at health professionals. The first questionnaire was completed by 364 patient-consumers. The second was completed by 95 health professionals (doctors and pharmacists). The data collected from the questionnaires were then analyzed using the SPSS program. From the analyzes, we found that among most patients the term "generic" is familiar, but there is a lack of proper information. However, almost half patients have positive attitude towards generics and are willing to use them with the recommendation of a physician primarily, or a pharmacist. Also, the most important reasons that make them buy a drug is knowing it’s safe and effective. The analyzes of the responses of health professionals found that there is lack of knowledge and correct information among them. While they are willing to prescribe/dispense generics, however, original drugs are preferred, probably due to lack of confidence in the regional EMEA. According to them, improvement of the reliability of the Agency and better information of the health professionals will help increase the use of generics. The state has already adopted several measures to increase the use of generics. But it is proposed that a more integrated effort, through the channels of health professionals, pharmaceutical industry and patients and consumers should take place so that to this effort and purpose are achieved.

Generic drugs and generic substitution from the patient perspective I. Autor: Jana Novotná Supervisor: PharmDr. Josef Malý, Ph.D. Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University in Prague Introduction: Generic substitution and generic drugs are important instruments of drug policy in many countries, which allow to reduce price of medicines, while maintaining their quality. Experience shows that a prerequisite for the rational use of both instruments is sufficient awareness among both health professionals and patients. Objective: The aim of this study was to analyze the opinions, knowledge and experience of patients regarding generic drugs and generic substitution. Methods: Data were collected between 1 March 2015 and 31 March 2015 in a workplace practitioner in Prague. It was an observational survey. We contacted all patients who visited a doctor during that period. Patients had to agree to their inclusion in the investigation and also meet "inclusion criteria" (e.g., at least 18 years old, literate in Czech, long-term use at least one medicine). The questionnaire included 28 questions (4 open and 24 closed), focusing on socio-demographic characteristics and knowledge, opinions, experiences and self-activity of the respondent regarding generic...

Generic drugs and generic substitution from the patient perspective II. Autor: Martina Kůtková Tutor: PharmDr. Josef Malý, Ph.D. Department of Social and Clinical Pharmay, Faculty of Pharmacy in Hradec Králové, Charles University in Prague Introduction and aim: Generic drugs and generic substitution are an integral part of the healthcare systems of many countries. The aim of this thesis was to carry out an research which was focused on attitudes, opinions and experiences of patients (general public) regarding generic drugs and generic substitution and to analyze extracted results. Metodology: Data were collected since February to June 2016 in a workplace practicioner in Jičín. We asked all patients who came to the doctor's office during that period. Data were collected through printing anonymous questionnaire. The questionnaire was piloted. Patients got a cover letter with questionnaire together. Respondents were categorized based on the cover letter and the questionnaire was filled out by the respondents who the survey was focused on. The questionnaire included 36 questions (26 closed, 7 open and 3 half-open). The first part of the questionnaire (first 10 questions) was focused on socio- demographic characteristics of respondents. The rest of the questionnaire detected patient's knowledge of...

[pt] O propósito deste estudo é analisar o advento dos genéricos e verificar seu impacto nas estratégias competitivas implementadas por empresas da indústria farmacêutica brasileira. Este trabalho adota como base o estudo de Michael Porter sobre tipologias, identificando as estratégias relevantes e os grupamentos existentes nesse segmento industrial, buscando também relacionar o posicionamento estratégico assumido pelos laboratórios ao desempenho observado. O método de análise constitui-se do levantamento de uma base de dados obtida a partir de relatórios de consultorias especializadas, da identificação de indicadores estratégicos e de desempenho, bem como da implementação de procedimentos estatísticos. Busca-se ainda relacionar os posicionamentos e desempenhos identificados entre os anos de 1999 e 2002 aos resultados obtidos no estudo envolvendo o período imediatamente anterior ao advento dos genéricos, isto é, ao período compreendido entre os anos de 1995 e 1998, permitindo-se assim a elaboração de uma análise longitudinal da indústria. Os resultados obtidos sugerem um forte deslocamento no sentido de adoção de custos como arma estratégica, bem como demonstram uma perda de foco estratégico por parte dos laboratórios voltados à diferenciação. Por fim, o estudo também identifica indícios de queda na rentabilidade total da indústria. / [en] The aim of this study is to analyze the launching of generic drugs and verify their impact on competitive strategies implemented by Brazilian pharmaceutical companies during the period of 1999 to 2002. This research is based on Michael Porter´s studies on strategic typologies, identifying the relevant strategies and the existing groups in this industrial sector. The study also relates the strategic positioning of the pharmaceutical companies to the achieved performance. The methodology adopted is based on the analysis of collected database from reports of specialized consulting companies, the survey of strategy and performance indicators, as well as the implementation of statistical procedures. Furthermore, the relation of positioning and performance identified in this study to the results obtained in a previous one involving the pharmaceutical industry during the period immediately before the generic drugs launching, that is, the period between the years 1995 and 1998, is also investigated, thus allowing a longitudinal analysis of the Brazilian pharmaceutical industry. The results suggest a movement to adoption of cost as strategy, as well as demonstrate a loss of strategic focus of the pharmaceutical companies that are oriented to differentiation. Finally, the study also identifies a reduction yield trend of the pharmaceutical industry.

Em 1999, o mercado de medicamentos genéricos foi criado no Brasil. Com isso, iniciou-se uma nova fase do mercado farmacêutico brasileiro. Através de dados cedidos pela ANVISA sobre o mercado varejista brasileiro, objetivou-se testar em até que ponto a política de medicamentos genéricos tem logrado êxito. Foram utilizados dados em painel para analisar o impacto da entrada dos medicamentos genéricos sobre a estrutura do mercado, assim como o impacto nos preços e na quantidade vendida entre 2003 e 2007. Os resultados foram favoráveis à diminuição da concentração dos mercados relevantes da amostragem e também ao aumento da quantidade comercializada. Em relação aos preços, o modelo se mostrou pouco significativo, provavelmente pela política de medicamentos genéricos ser um instrumento indireto de controle de preços. De qualquer forma, os resultados encontrados parecem sugerir o bom andamento da política de medicamentos genéricos, o que é um alívio em se tratando de um mercado tão essencial para o bem-estar da população. / In 1999, the generic medicines market was created in Brazil. Thus, a new phase of the Brazilian pharmaceutical market began. Through data provided by ANVISA on the Brazilian retail market, aimed to test in how far the generic drug policy has been successful, we used panel data to analyze the impact of the entry of generic drugs on the market structure, as well as the impact on prices and quantities sold between 2003 and 2007. The results were favorable to the policy as they show decrease of the concentration level in the relevant markets of the sample and also increase of the quantity sold. Regarding prices, the model was negligible, probably due to generic drug policy being an instrument of indirect price control. Anyway, the results seem to suggest the progress of the generic drug policy, which is a relief when it comes to a market as essential for the welfare of the population.

[pt] O propósito desse estudo é analisar as estratégias competitivas implementadas por empresas da indústria farmacêutica brasileira. Este trabalho adota como base o estudo de Chrisman sobre tipologias, identificando as estratégias relevantes e os grupos existentes nessa indústria, relacionando o posicionamento estratégico adotado pelos laboratórios com seu desempenho no setor. Além disso, a pesquisa busca analisar impactos do advento dos genéricos nessa indústria. O método de análise utilizado constituí- se do levantamento de uma base de dados obtida a partir de relatórios de consultorias especializadas, da identificação de variáveis estratégicas e de desempenho e da implementação de procedimentos estatísticos. Os posicionamentos e desempenhos identificados entre os anos de 1999 e 2002 sugerem a adoção de redução de custos como arma estratégica, ao contrário do que acontecia antes no mercado, onde havia um foco maior em diferenciação. O estudo também sugere que os grandes laboratórios ainda conseguem obter um desempenho superior baseados em suas marcas reconhecidas e grande escala de operação, enquanto os laboratórios nacionais, de menor porte, estão investindo cada vez mais no segmento de medicamentos genéricos. / [en] The aim of this study is to analyze the competitive strategies implemented by Brazilian pharmaceutical companies. This research is based on Chrisman s studies on strategic typologies, identifying the relevant strategies and the existing groups in this industrial sector. The study also relates the strategic positioning of the pharmaceutical companies to the achieved performance and analyzes the impact of the generic drugs launching in the sector. The methodology adopted is based on the analysis of collected database from reports of specialized consulting companies, the survey of strategy and performance indicators, as well as the implementation of statistical procedures. The relation of positioning and performance identified in the period between the years 1999 and 2002 suggests a movement to adoption of cost strategy, against the differentiation oriented focus of the industrial sector before the generic drugs launching. The results also suggest that the great companies are still able to have a superior performance due to their well known marks and operation scale, while smaller companies tend to invest in the generic drugs segment.