Legal. Legal framework: Yes. Authorizing legislation: Ley N° Ley de Los Productos Farmaceuticos, Dispositivos Médicos y Productos Sanitarios (Nov. Relevant documents: Ley Nº ‑ Ley de los Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (Law No. on Pharmaceutical . Ley N° Ley de los Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (Law No. on pharmaceutical products.
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The data that support the findings of this study are available from the Peruvian Drug Regulatory Agency but restrictions apply to the availability of these data, and so are not publicly available. Data are however available from the author upon reasonable request and with permission of the Peruvian Drug Regulatory Agency. This study evaluated the registration of brand and generic anti-infectives before and after the agreement and implementation of the NDP and assessed the availability of anti-infectives in community pharmacies located in Arequipa-Peru.
In addition, ten retail pharmacies located in different socio-economic areas in Arequipa were sampled in August Descriptive statistics and chi-square test were used for the analysis. New registrations for brand and generic anti-infectives decreased from to to 60 and to 20 respectively. Re-registrations were from brand and generics in to 6 brand and 5 generics in Anti-infectives awaiting registration increased from 0 in to brand and generics in The retail pharmacy survey included anti-infectives.
These pharmacies carried Pharmacies in the low socio-economic area of the city had the highest proportion of generics High socio-economic areas had highest proportion of branded anti-infectives The new NDP reduced the number of brand and generic registrations; generics had the largest decline in registrations. Anti-infectives found in pharmacies located in low-income areas were more likely to be generics, and less likely to be currently registered by DIGEMID.
The potential reduction in generic registrations resulting from the implementation of the NDP as a consequence of the bilateral trade agreement could result in lower availability of low cost medicines, but may increase the safety, efficacy and quality of marketed medicines.
Free Trade Agreements FTA are controversial for threatening important aspects of health especially access to affordable medicines. Multilateral, bilateral, and regional FTAs, as part of economic globalization, have included trade in health insurance, pharmaceuticals, and health services making health care reform no longer just a matter of national policy. FTAs make it difficult for countries to transfer from market-based health care systems to publicly funded health care programs once health care markets are opened to competition [ 1 ].
Many FTAs include provisions such as government procurement, competition policy, intellectual property IP rights protection, e-commerce, and more [ 2 ]. The IP rights about patent protection explicitly the length of patent protection and second use patents and data exclusivity are the provisions that could restrict the most access to generic medicines, and unfortunately, they have become the norm in the US [ 34 ] and European trade agreements [ 5 ].
The FTA became effective on February 1, ; it aimed to improve the overall commercial and investment activity by eliminating or reducing tariffs on many goods including pharmaceuticals, accelerating the customs clearance process for US imports, and fortifying the protection of IP rights [ 6 ].
The IP chapter includes, among others, stronger protections for patents and test data as well as tough penalties for piracy and counterfeiting.
The agreement restricted the grounds for invalidating patents lej set up rules for protecting test data submitted for marketing approval of medicines article If the medicine is approved by the FDA marketing registration the term of protection starts running from the time of the first approval article According to Rangel [ 7 ], this would provide better access to medicines while maintaining strong protection for innovation.
The most important modifications related to the pharmaceutical sector were included in Article 5 that regulates data exclusivity, and Article 6 that replaced the requirements for the registration of pharmaceuticals, medical devices and sanitary products previously contained in Article 50 of the General Health Law of [ 9 ]. The General Health Law approved a simple procedure for the registration application process of pharmaceuticals that included an affidavit ensuring quality, safety and efficacy; analysis protocol from another country; and a free sale certificate.
A comparison between the registration laws before and after the Free Trade Agreement presenting the main changes related to medicines. The Supreme Decree —SA was issued to rule Lawparticularly the new requirements for the registration of pharmaceuticals, stating in part:. That, it is necessary to modify the system of registration of pharmaceutical products so that the health authority can demand certain information relevant to noo evaluation and determination of the safety and efficacy of said products …….
ley no 29459 pdf
However, the NDP did not define a timeline for implementation and it was not initiated until the enactment of Law in The objectives of Law were to adapt the national drug regulation to the requirements of the FTA, to implement new drug registration requirements, and to reach the objectives of the NDP of universal access and rational use of medicines.
The Law stipulates the time allowed to review applications and grant marketing approvals according to the new categories of medicines:. The fees for registration increased fold and includes control activities and health surveillance. The technical requirements and the application documentation increased requiring presentation of therapeutic equivalence studies to demonstrate interchangeability, information on safety and efficacy pre-clinical and clinical studiesa risk management plan for new medicines, Good Manufacturing Practice GMP certification, and analytical studies [ 14 ].
The technical information on safety and efficacy of the medicines must be submitted for registration and re-registration, but is not required for subsequent re-registrations unless it is required to address new safety and efficacy information. Registration and re-registration require studies of interchangeability; however, in vivo bioequivalent studies are only required for high risk medicines.
Law 29, also includes chapters regarding universal access and rational use of medicines, promotion and research [ 14 ]. The Peruvian health care system is divided into public and private sectors. The public health sector is financed by subsidies indirect contributions and by social security direct contributions. The government manages and finances health services and medicines through Integrated Health Insurance with a low cost or no cost to people below the poverty or extreme poverty levels respectively.
NISS provides free health care and medicines exclusively for salaried workers and their family members in their own hospitals and clinics. The private sector sells services to NISS in their clinics and doctor offices. The leyy and police have their own health system and infrastructure. The private health care system is mainly represented by clinics and other private entities like companies providing health insurance plans.
NISS performs centralized acquisitions of medicines and distributes them at a national level. Medicines are mostly distributed directly by the pharmaceutical manufacturers to hospitals and drugstore chains, also to large wholesalers, which mainly distribute brand imported medicines.
Small wholesalers mainly distribute medicines to independent private community pharmacies. Whereas, the constitution protects free market competition and bans price nk measures in the private sector. This study is intended to answer some 2949 the research questions that arise as a result of the signing of the trade agreement and the subsequent implementation of the NDP. For the case study, data were collected from 10 retail pharmacies located leyy different socio-economic strata in the southern city of Arequipa, the second most industrialized and commercial city of Peru.
The metropolitan area of the province of Arequipa has pharmacies and drugstores located among its 18 districts.
Ldy pharmacies 1 privately owned by a university community health center, and 1 2459 with independent owner were sampled from the low socioeconomic stratum representing 1. Two pharmacies each from different pharmacy chains, one located inside a private clinic were sampled in the districts of the high socio-economic stratum comprising a 1. The other 6 pharmacies 3 privately owned, and 3 from different pharmacy chains were representative of the middle socio-economic stratum comprising a 1.
The socio-economic strata were determined using the poverty level per district from a study based on a population census of [ 18 2945. The pharmacies were selected based on their location and type of pharmacy within the private sector.
A convenience, non-random sample was selected from three different socio-economic strata representative of the city. The impact of the regulations on the pharmaceutical market was estimated by creating a registration history for each anti-infective in the period of tobefore and after the implementation of both the FTA and the 294559.
The registration history included 8 statuses: For the case study, pharmacies were visited only once.
The data were collected from July 30 to August leey, The following information was recorded: The DIGEMID website index was used to update the information from the database until August for statuses 3 to 8 awaiting registration, expired, canceled, not approved, deserted or disregarded, and suspended registrations. The index is updated every month. The updated information was applied in the next part of the research, the case study.
A case study was performed to determine the availability of anti-infectives at retail pharmacies comparing these with the anti-infectives registered through DIGEMID. Data from the 10 retail pharmacies were matched with the anti-infectives DIGEMID database from January to Augustto record the registration history of each anti-infective. The proportion of generic and brand anti-infectives sold in each retail pharmacy was also calculated as well as their country of origin.
ley no pdf – PDF Files
The registration expiration date and the ATC pharmacological-chemical class were determined for products with statuses 4 to 8. Microsoft Office Excel was used to perform descriptive statistics. Mann-Whitney U test was performed when the chi-squared test determined statistically significant differences within the proportions. There were antibacterials; antimycotics; antimycobacterials; and antivirals. The number of anti-infectives that were re-registered declined from in to 11 in The awaiting registrations started with 48 inincreasing to in The number of registrations that expired from to went down and then up; in there were expired registrations, in there wereand in there were Furthermore, the canceled nk increased from 10 in to 99 in and dropped again to 14 in The proportions of brand anti-infectives new registrations were greater than the ones for generics throughout 294599 study period, 294599 this difference was even greater from to Number and proportion of new registrations of brand and generic anti-infectives from January to April The proportions for brand 229459 generics were quite similar from to In brand anti-infectives reached There were no anti-infectives re-registered through the first four months of Number and proportion of brand and generic anti-infectives re-registered from to The proportions for brand anti-infectives were In contrast, the proportions for generics were The awaiting registrations numbers gradually increased from to for both types of medicines.
A total of anti-infectives were identified from ten community pharmacies in Arequipa, Peru. Brand and generic anti-infectives available at 10 retail pharmacies cluster by socio-economic strata.
The non-Peruvian anti-infectives increased according to the socioeconomic stratum. In the case of generics Fig. However, the other two strata showed an opposite behavior: Peruvian and non-Peruvian generic anti-infectives available at 10 pharmacies in Arequipa-Peru divided by socio-economic strata. The higher proportion of new registrations was observed in the pharmacies of the low socio-economic stratum; however, re-registrations were almost the same in the three strata as well as for those awaiting registration.
Expired anti-infectives status 4 were found in pharmacies in all three strata. Registry statuses of anti-infectives by socio-economic strata from 10 retail pharmacies at Arequipa, Peru. There were 82 anti-infectives with statuses 4 to 8 found in the 10 retail pharmacies by August Of the anti-infectives with status 4 expired registration43 were brand and 9 were generic products; and from these, 33 were of Peruvian origin and 19 of non-Peruvian origin.
Also, 18 of these anti-infectives had a registration expiration date of ; 14 had a registration expiration date of ; and 9 had a registration expiration date of Furthermore, this table shows the ATC classification for anti-infectives with statuses 4 to 8 found in the retail pharmacies.