FINANCIAL EFFECTS FROM INTRODUCTION OF EUROPEAN EGG MARKETING STANDARDS ON THE LAYER FARMS IN R. MACEDONIA

This paper presents the financial effects from introduction of the new EU method for grading the eggs according the size (weight) in 4 classes instead of Macedonian method of grading in 7 weight classes based on the comparative analyze of production records in three flocks of ISA commercial layers (Flock 1 - 18125, Flock 2 – 17587, Flock 3 - 16818). The comparison of the financial effects of the introduction of the EU grading system is made by the partial budgeting analysis. Application of European model for egg grading resulted in increased income of about 18-37 denars per average hen-day layer that improves the financial effects at the layer farms. Expressed per unit of production, egg grading based on the egg weight in 4 classes results in increased income per unit of production of 0.1-0.2 denars and is significant increase of the farm profitability knowing that each layer produces around 300 eggs during one production cycle of one year. Hence, the use of standards goes beyond marketing aspects, and can financially support the market without budgetary implications

Evaluating an information campaign about rural development policies in (FYR) Macedonia

This paper investigates the effects of an information campaign about a governmental rural development program (RDP) in the Former Yugoslav Republic of Macedonia on the farmers’ intention to participate in the RDP. In the course of a survey among farmers, the treatment group received an information brochure with relevant details on selected RDP measures, while the control group received no information. Even though the intervention had been planned as experiment, randomization was not properly conducted, requiring sample adjustments and controlling for observed covariates in the estimation process. The results suggest that while the intervention succeeded in informing farmers, it had a negative, albeit marginally statically significant, effect on farmers’ reported possibility and intention to use RDP support in the near future. Evidence from further outcome variables suggests that this may be due to the information about administrative burden associated with RDP participation provided in the brochure. We also find that the negative effect is driven by the subsample of unprofitable farmers

MACEDONIAN AGRICULTURAL CAPITAL MARKET AND SUPPORTING MECHANISMS: AN OVERVIEW

The Macedonian agricultural capital market is not efficient enough, although there have been some improvements due to the established supporting mechanisms. This paper aims to identify current gaps between agricultural financial services’ and mechanisms’ supply and demand on the agricultural capital market. In this regard, literature and other available secondary sources have been reviewed. Additionally, focused discussions with different stakeholders in the agricultural capital market were conducted, including representatives from the capital demand side (farmers and their associations), and supply side (banks, saving houses, and their associations), as well as supporting institutions and intermediaries (government institutions and donor projects that work towards improvement of farmers’ access to finance in the country). Crediting is one of the key drivers of agricultural and rural development. There are other external financial sources that should be considered, which could contribute in improved capital flow to the agricultural sector. The results revealed critical segments in the agricultural capital market based on the mismatches between the supply and demand for capital and supporting mechanisms, and suggest directions for further improvements of this market. The findings may serve as a baseline for future policy settings and enhancement of a more efficient development of the agricultural capital market in the country

Assessing technical efficiency of vegetable farms in North Macedonia

Farm economic performance measuring is important for farm management purposes and for assessing the impact of agricultural policy measures. Efficiency studies enable assessment of farm performance since highly efficient farms are considered to have higher potential for operating in a changing economic and technological environment. The aim of this paper is to assess the technical efficiency of vegetable farms in North Macedonia, utilising Data Envelopment Analysis, as a non-parametric approach estimating the relative efficiency of decision making units producing multiple outputs and using multiple inputs. The analysis is based on Farm Monitoring System data including 75 vegetable farms in 2011 survey. Apart from baseline scenario, additional scenarios include available agricultural policy support in 2011 and 2016. The average technical efficiency of vegetable farms is 0.62 considering constant returns to scale, i.e. 0.71 and 0.75 considering variable returns to scale (in output and input oriented perspective, respectively). With better farm management, technical efficiency score can be improved on average by 25%. Technical efficiency increases slightly with subsidies, on average by 2 to 3%. Analyses based on farm level data, are valuable when estimating the effects of implementation of agricultural policy as well as when creating new policy interventions

The role of rural development funds in EU pre-accession countries: the case of IPARD II

The European Union is a key strategical priority for the pre-accession countries in the Western Balkan and Turkey. The Instrument for Pre-Accession Assistance (IPA) assists countries aspiring for EU membership to prepare their institutional and administrative capacities for future compliance in all sectors including agriculture and rural development. Apart from the financing component, the role of IPARD is much broader in preparing the preaccession countries for effective implementation of structural and rural development funds upon accession. This paper aims to provide a comparative cross-country analysis on the IPARD programme 2014-2020 (IPARD II) funding of the current beneficiaries (Albania, Montenegro, North Macedonia, Serbia and Turkey). The main derived indicators include the use of IPARD II funding, measures and absorption rates. IPARD II payments are effectuated in all candidate countries from 2019, while payments started earlier in 2017 in Turkey and in 2018 in North Macedonia. With the prolonged start of the IPARD II programme, significant amount of the available funds remains unused, and the number of implemented measures is still limited. There are noticeable country differences in terms of expenditure among measures, but overall, the largest share of used funds so far is dedicated to investments in physical assets in primary production and processing. All countries have established some form of institutional and administrative capacities for implementing the agricultural and rural development policies, especially for the IPARD funds. Still, there is a need for additional capacity building, due to numerous factors, among which the dynamic environment with many continuously changing aspects (CAP reform, accession methodology, climate change or issues arising from the ongoing Covid-19 pandemics). Further promoting the programme, strengthening the national institutions’ set-up and capacity, aligning to the beneficiaries needs, and supporting them in preparing viable or sustainable projects are recommendations for better use of the current funds, as well as for the preparation of IPARD III cycle

Report on the Status of Organic Agriculture and Industry in North Macedonia

Report on the Status of Organic Agriculture and Industry in North Macedoni

Evaluation of nonclinical safety studies in support of development of paediatric pharmaceuticals

Uvod: Večina zdravil, ki se uporabljajo v pediatrični populaciji, ni bilo uradno razvitih za uporabo v tej starostni skupini. Razvoj zdravil je že sam po sebi zelo zapleten proces, še težje pa je razviti zdravila, ki so primerna tudi ali zgolj za pediatrične bolnike. Zato je Mednarodni svet za usklajevanje tehničnih zahtev glede zdravil za uporabo v humani medicini (ICHang. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) izdal številne smernice, za razvoj kakovostnih, varnih in učinkovitih zdravil za uporabo v pediatrični populaciji. Cilj: Cilji magistrske naloge so pregledati smernico ICH S11 »Neklinične študije varnosti v podporo razvoju pediatričnih farmacevtskih izdelkov«, smernice regulatornih organov Evropske agencije za zdravila in Ameriške agencije za hrano in zdravila, določiti razlike v priporočilih za neklinične študije za odrasle in otroke ter pregledati zdravila z indikacijami za uporabo v pediatrični populaciji, registriranih pri Evropski agenciji za zdravila za obdobje od 1. 1. 2011 do 31. 12. 2020. Metode: Za pregled potrebne dokumentacije smo uporabili podatkovne zbirke uradnih strani agencij: – podatkovno zbirko ICH: ICH S11 in ICH M3(R2), – podatkovno zbirko FDA: S11, – podatkovno zbirko EMA: S11, European public assesment report (EPARslo. Evropsko poročilo o oceni zdravila). Rezultati in razprava: Na podlagi pregleda dokumentov, uporabljenih v tej študiji, smo prišli do naslednjih rezultatov: – Zahteve, določene v smernici ICH S11, so sinhronizirane s strani obeh regulativnih organov, Evropske agencije za zdravila za Evropsko unijo in Agencije za hrano in zdravila za Združene države Amerike. – Še vedno obstaja več ključnih razlik med zahtevami, določenimi za neklinične študije za pediatrično populacijo in odrasle. – Za obdobje od 1. 1. 2011 do 31. 12. 2020 je bilo pri Evropski agenciji za zdravila registriranih 673 novih zdravil (to število ne vključuje cepiv in celične terapije) in 230 od teh je imelo indikacijo za pediatrično uporabo. Od vseh 230 zdravil jih je bilo le 14 registriranih za uporabo le v pediatrični populaciji. Zdravila za uporabo (tudi) v pediatrični populaciji so bila razvita za 14 različnih terapevtskih skupin. Zaključek: Smernice izdane s strani regulatornih organov EMA in FDA nakazujeta, da so zahteve za Evropsko unijo in Združene države Amerike sinhronizirane s smernico ICH S11. Še vedno obstaja velika razlika med zahtevami za razvoj nekliničnih študij med odraslo populacijo in otroki, kar je lahko izziv za farmacevtsko industrijo. Čeprav je bilo veliko zdravil registriranih pri EMA z indikacijo za uporabo (tudi) v pediatrični populaciji, je bil le majhen delež namenjen le pediatrični uporabi.Introduction: Most medicines used in the paediatric population have not been formally developed for use in this age group. Drug development itself is a very complex process, but in the case of the paediatric population, it is even more difficult to develop drugs that are also or only suitable for paediatric patients. As a result, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has issued a number of guidelines for the development of high-quality, safe and effective medicines for use in the paediatric population. Aim: This study aims to provide an overview of the guideline ICH S11 "Nonclinical safety testing in support of the development of paediatric pharmaceuticals", the guidelines of the regulatory bodies European Medicines Agency and United States’ Food and Drug Administration, to identify the differences in recommendations for nonclinical studies in adults and paediatrics, and to review the registered drugs with paediatric indications registered with the European Medicines Agency for the time period of 1.1.2011 – 31.12.2020. Methods: We used the official pages\u27 databases of the agencies to review the needed documentation: – the ICH database: ICH S11 and ICH M3(R2), – FDA database: S11 standard, – EMA database: S11 standard, European public assessment reports. Results and discussion: Based on the overview of the documents used for this study, we concluded the below results: – Requirements set out in the ICH S11 standard are synchronised by both regulatory bodies, the European Medicines Agency for the European Union and the Food and Drug Agency for the United States of America. – There are still several key differences between requirements set out for nonclinical studies for paediatrics and adults. – For the period of 1.1.2011 – 31.12.2020 on the European Medicines Agency there were registered 673 new medicines (with the exclusion of vaccines and cell therapy) and 230 of them had an indication for paediatric use. Out of all 230 medicines, only 14 were registered for use of the medicines only in paediatrics. The medicines with an indication for paediatrics population (also) were developed for 14 different therapeutic groups. Conclusion: Guidelines issued by the regulatory authorities EMA and FDA indicate that the requirements for the European Union and the United States of America are synchronized with the ICH S11 guideline. There is still a large gap between the requirements for the development of non-clinical studies between the adult population and children, which can be a challenge for the pharmaceutical industry. Although many medicinal products were registered with the EMA with an indication for use (also) in the paediatric population, only a small proportion were intended for paediatric use only

PARTIAL EQUILIBRIUM MODEL AS A TOOL FOR POLICY ANALYSIS IN AGRICULTURE: AN EMPIRICAL EVIDENCE OF MACEDONIA

Agricultural sector modeling based on partial equilibrium modelling of the supply and demand has become standard approach in the market outlooks and policy impact studies. The model builders and users reveal many pros and cons of the process and results of modelling. The Macedonian experience confirms some typical obstacles and at the same time faces some new ones with a local perspective. The paper provides a summary of the milestones in modelling the partial equilibrium model for the livestock-feed sector in Macedonia with main focus on the obstacles and limitations in the process. This experience is expected to be useful for the countries in the Western Balkan region planning to build a sector models based on partial equilibrium concept as a policy analysis tool

Assessing the Future Development of the Macedonian Agriculture: Partial equilibrium model of livestock-feed sector

The country is facing one of the biggest challenges since its independence – the process of the EU accession. Taking into consideration that „forecasting important economic events is source of power“ (Howitt, 2005), the aim of this paper is to develop a model in order to assess the impact of the EU membership on the Macedonian agriculture. The model is recursive, dynamic, multi-product partial equilibrium model for the meat, dairy and cereals sector in the Republic of Macedonia. It follows the AGMEMOD principles, hence comprising the local features of the Macedonian agriculture. The baseline scenario shows a positive growth of the pig meat, lamb meat and cow milk sectors. On the other hand, in the EU scenarios the most positive effect is expected in the extensive sectors, e.g the sheep and beef productions. The grains show modest growth on the supply side, but the projections on the net-trade demonstrate further deficit increase. The biggest gain in the EU scenarios comes from the higher level of prices, but also from the higher budgetary support. Compared with the experiences of the previous enlargements, the model confirms the expectations about the development of the selected sectors after the EU accession

Sheep meat balance in Republic of Macedonia Section 2 . Agricultural Economics and Rural Sociology Sheep meat balance in Republic of Macedonia

Abstract Sheep meat is a traditional product for the Republic of Macedonia, with a decreasing production trend in the last fifteen years. The aim of the paper is to analyze the changes in the sheep meat balance and to measure the declining tendency of this sub-sector. The results show that the number of sheep as well as the sheep meat production decreased by one-third in the research period (1995)(1996)(1997)(1998)(1999)(2000)(2001)(2002)(2003)(2004)(2005)(2006)(2007)(2008)(2009), whereas the meat exports increased by one-third. There are many factors contributing to this situation, resulting into an increased cost of production and a decreased the farmers' return. In the conclusion of the article it is stated that governmental actions could have a significant role in order to avoid further deterioration of this sub-sector with huge social meaning for the Republic of Macedonia