Diretrizes regulatórias aplicáveis à cadeia dos produtos para saúde

A ciência e a tecnologia cada vez mais vêm proporcionando avanços em produtos inovadores. Particularmente na área da saúde nota-se eminente sinergismo entre os materiais utilizados, suas propriedades de biocompatibilidade, biofuncionalidade, processabilidade, esterilidade e a área de aplicabilidade no organismo humano. O setor farmacêutico por apresentar grande complexidade exige conhecimentos multidisciplinares, atualizados e em conformidade às tendências internacionais. A Agência Nacional de Vigilância Sanitária (ANVISA) tem sob sua responsabilidade extensa diversidade de bens, serviços e produtos, dentre eles estão os correlatos, que também compreende os produtos para saúde. Os produtos para saúde são classificados conforme o seu risco, no Brasil podendo apresentar até quatro classes, sendo as classes III e IV as que caracterizam maior risco. Para alguns produtos, devido seu risco sanitário, é compulsório a Certificação de Conformidade pelo Instituto Nacional de Metrologia, Qualidade e Tecnologia (INMETRO) previamente a concessão de seu registro sanitário pela ANVISA. Dentre as normas técnicas aplicáveis pelo INMETRO estão as normas da Associação Brasileira de Normas Técnicas (ABNT) e na sua ausência, as normas da International Organization for Standardization (ISO). Outros requisitos técnicos e regulatórios devem ser contemplados com o propósito de comprovação da segurança e eficácia dos produtos. Entretanto, as regulamentações sanitárias inerentes a essa categoria de produtos ainda se encontram incipientes no país. A desenvoltura do setor produtivo nesse segmento pode ser evidenciada pelo aumento de novas solicitações na ANVISA e de seu crescimento na balança comercial. No entanto, observa-se pouco estudo e entendimento do setor regulado e regulador referente à relação mútua entre ANVISA, INMETRO e ABNT e quanto à regulação sanitária aplicável para obtenção da anuência do produto ao consumo. Na conjuntura das demandas apontadas o objetivo deste estudo foi avaliar o processo regulatório aplicável à cadeia produtiva dos produtos para saúde com a finalidade de compreender a relação entre ANVISA, INMETRO e ABNT na garantia da qualidade, segurança e eficácia dos produtos. A metodologia aplicada neste trabalho foi à pesquisa qualitativa. Com o auxílio da pesquisa documental constatou-se que o processo regulatório brasileiro é complexo, específico e robusto e apresenta estrutura e exigências semelhantes dos Estados Unidos e União Europeia. A fiscalização pós-uso é uma tendência internacional e a ANVISA vem adotando com frequência com intuito de acompanhar a qualidade dos produtos comercializados. As três instituições apresentam competências definidas e regulamentadas, bem como mecanismos de inter-relação por meio de conselhos consultivos. O estudo de caso caracterizou que o perfil dos profissionais do setor regulado apresenta em grande percentual formação na área da saúde e nível de pós-graduação, porém o nível de conhecimento dos principais conceitos relativos aos produtos para saúde é parcial, reforçando a necessidade de incentivos de capacitação de recursos humanos em regulação em saúde.

An economy with unrealistic indicators: an evaluation of the economic situation in Belarus and a forecast for 2013. OSW Commentary No. 103, 2013-02-20

The macroeconomic results achieved by Belarus in 2012 laid bare the weakness and the inefficiency of its economy. Belarus’s GDP and positive trade balance were growing in the first half of last year. However, this trend was reversed when Russia blocked the scheme of extremely lucrative manipulations in the re-export of Russian petroleum products by Belarus and when the demand for potassium fertilisers fell on the global market. It became clear once again that the outdated Belarusian model of a centrally planned economy is unable to generate sustainable growth, and the Belarusian economy needs thorough structural reforms. Nevertheless, President Alyaksandr Lukashenka consistently continues to block any changes in the system and at the same time expects that the economic indicators this year will reach levels far beyond the possibilities of the Belarusian economy. Therefore, there is a risk that the Belarusian government may employ – as they used to do – instruments aimed at artificially stimulating domestic demand, including money creation. This may upset the relative stability of state finances, which the regime managed to achieve last year. The worst case scenario would see a repeat of what happened in 2011, when a serious financial crisis occurred, forcing Minsk to make concessions (including selling the national network of gas pipelines) to Moscow, its only real source of loans. It thus cannot be ruled out that also this time the only way to recover from the slump will be to receive additional loan support and energy subsidies from Russia at the expense of selling further strategic companies to Russian investors.

An inexhaustible source of income? The significance of Belarusian refineries and the outlook for the future. OSW Commentary No. 81, 2012-06-20

Belarus generated a surplus at US$1.9 billion in foreign trade in goods and services in the first four months of 2012 as compared to a deficit of US$2.8 billion for the same timeframe a year earlier. Minsk owes this, its highest positive trade balance since 1991, mainly to a significant increase in exports of petroleum products manufactured by the refineries in Navapolatsk and Mazyr. This is a consequence of the favourable contract for supplies of Russian oil until 2015 which Belarus signed in December last year. This contract has resulted in a de facto resumption of Russia subsidising Belarus. The favourable conditions of Russian oil supplies will allow the Belarusian refineries to remain the driving force of the country’s economy, and the Belarusian government will not allow them to be privatised, which Russia has been seeking for years. The two refineries initiated an ambitious modernisation programme, which is aimed at increasing their output and improving the quality of their production. Owing to this, their share in the market of petroleum products in the region, including on the Polish market, may grow within the next few years.

What prospects for transport infrastructure and impacts on growth in southern and eastern Mediterranean countries? MEDPRO Report No. 3, February 2013

Lack of adequate infrastructure is a significant inhibitor to increased trade of the countries of the Mediterranean region. Bringing their transport infrastructure to standards comparable with countries of a similar per capita GDP will be costly but worthwhile. We compare the current quantities of six types of transport infrastructure with international benchmarks, and estimate the additional quantities needed to reach the benchmarks. We also estimate the cost of that infrastructure and express it as a percentage of GDP. Finally we make tentative estimates of how much trade might be generated and how this might impact on GDP. All the estimates are made for 11 southern and eastern Mediterranean countries (SEMCs) under four scenarios. The greatest need for additional infrastructure is for airport passenger terminals (between 52% and 56%), whereas the least is for more unpaved roads (between 7% and 13%). The investment (including maintenance) cost would be between 0.9% of GDP and 2.4% of GDP, although the investments in some countries would be between 1.4% and 4.5% of GDP. The impact on non-oil international trade would be substantial, but with differences between imports and exports. The overall trade balance of the 11 countries would be an improvement of between 5.4% and 17.2%, although some countries would continue to have a negative balance. A final assessment is made of the benefit ratio between the increase in GDP and the cost of transport investment. This varies between about 3 and 8, an indication of the high return to be expected from increased investment in transport infrastructure.

Filling the gap: open economy considerations for more reliable potential output estimates. Bruegel Working Paper 2015/11, October 2015

This paper argues that the Phillips curve relationship is not sufficient to trace back the output gap, because the effect of excess demand is not symmetric across tradeable and non-tradeable sectors. In the non-tradeable sector, excess demand creates excess employment and inflation via the Phillips curve, while in the tradeable sector much of the excess demand is absorbed by the trade balance. We set up an unobserved-components model including both a Phillips curve and a current account equation to estimate ‘sustainable output’ for 45 countries. Our estimates for many countries differ substantially from the potential output estimates of the European Commission, IMF and OECD. We assemble a comprehensive real-time dataset to estimate our model on data which was available in each year from 2004-15. Our model was able to identify correctly the sign of pre-crisis output gaps using real time data for countries such as the United States, Spain and Ireland, in contrast to the estimates of the three institutions, which estimated negative output gaps real-time, while their current estimates for the pre-crisis period suggest positive gaps. In the past five years the annual output gap estimate revisions of our model, the European Commission, IMF, OECD and the Hodrick-Prescott filter were broadly similar in the range of 0.5-1.0 percent of GDP for advanced countries. Such large revisions are worrisome, because the European fiscal framework can translate the imprecision in output gap estimates into poorly grounded fiscal policymaking in the EU.

Inventory investment and GDP characteristics in OECD countries

There are very few research studies on macroeconomic inventory behaviour of various countries. It is clear that macro inventories are the results of a large number of individual microdecisions. However, we believe that it is worth analysing how inventories develop in the individual countries and why we can see different tendencies. This paper is the newest piece in a series of studies on the above subject. We use the OECD database to analyse inventory trends between 1987 and 2004 in nine of the most developed economies of the world. Annual inventory investment data are used and their connections with other components of GDP expenditure (governmental and private consumption, investment in fixed assets and foreign trade balance as well as the annual growth rate of GDP) are examined by multi-variable statistical analysis. Conclusions include the steadily decreasing tendency of inventory fluctuations, the varying periods of higher and lower rates of inventory investments and the differences of main influencing factors by country.

Az agrárkereskedelem változása Magyarország és az Európai Unió között a csatlakozás után (The post-accession change in agricultural trading between Hungary and the EU)

2004-ben Magyarország kilenc közép-kelet-európai országgal együtt csatlakozott az Európai Unióhoz, ami számos változást idézett elő az agrárkereskedelem terén. A cikk célja, hogy a legfrissebb adatok és a szakirodalmi fejlemények tükrében bemutassa, hogyan alakult Magyarországon a mezőgazdasági alapanyagok és a feldolgozott termékek kereskedelme az Európai Unióval. A megnyilvánuló komparatív előnyök módszerét alkalmazva a cikk számos következtetésre jutott. Először is világossá vált, hogy a csatlakozás növelte az agrárkereskedelem intenzitását, ám negatív hatással volt a kereskedelem egyenlegére. Kimutatható továbbá, hogy Magyarország az alacsony hozzáadott értékű alapanyagexportra és a magas hozzáadott értékű feldolgozott termékek importjára koncentrált a csatlakozás után, noha ezek komparatív előnyei nagymértékben megváltoztak egy hatékony alkalmazkodási folyamat következtében. A változások tényét támasztják alá a különböző rövid és hosszú távú stabilitásvizsgálatok is, amelyek az agrártermékek megnövekedett versenyére utalnak az EU-15 piacán. Agrárpolitikai szempontból az elemzések alátámasztják a strukturális reformok szükségességét. / === / Numerous changes in agricultural trading from the EU accession of Hungary and nine other Central-East European countries in 2004. The article sets out to present, in the light of the latest figures and written contributions, how Hungary’s EU trade in agricultural raw and semi-processed products developed thereafter. It uses the method of manifest comparative advantages to reach its conclusions. First, it became clear that accession increased the intensity of agricultural trading, although it had a detrimental effect on the trade balance. It also appeared that post-accession Hungary was concentrating on exports of basic materials of low added value and imports of processed articles with high added value, although these comparative advantages were much altered by an effective process of adaptation. The fact of the changes is supported by various short and long-term stability examinations, which point to increased competition for agricultural products on EU15 markets. From the policy point of view, the analyses support the need for structural reforms.

Az EU csatlakozás hatása az új tagországok agrárkereskedelmére

2004-ben és 2007-ben tizenkét új tagország csatlakozott az Európai Unióhoz, számos változást okozva az európai mezőgazdaságban. Az egyik legfontosabb fordulat az egyes nemzetek mezőgazdasági- és élelmiszer-kereskedelmében következett be. Az eredmények azt mutatják, hogy az új tagországok mezőgazdasági- és élelmiszer-kereskedelmének intenzitása jelentősen nőtt a csatlakozás hatására, ugyanakkor a külkereskedelem mérlege ezen a területen nagymértékben romlott több országnál is. A számítások azt is alátámasztották, hogy jelentős koncentráció ment végbe a kereskedelmi partnerek és a termékek tekintetében egyaránt. Mindemellett egyértelművé vált az is, hogy az új tagországok kereskedelmének struktúrája meglehetősen egyoldalúvá vált: az alapanyagok exportálása mellett az importált javak döntő többsége a feldolgozott termékek köréből került ki. A komparatív előnyök vizsgálata rámutatott, hogy az új tagországok legfontosabb agrártermékei megnyilvánuló komparatív előnnyel bírtak a csatlakozás előtt és után is, habár a legtöbb esetben ezen előnyök komolyan csökkentek.. Döntéshozói szempontból vizsgálva az eredményeket egyértelműen megállapítható, hogy az új tagországokban strukturális változtatások szükségesek a negatív folyamatok megállítása érdekében. A legfontosabb stratégiai cél pedig elsősorban a magas hozzáadott értékű, hazai alapanyagokból készített termékek exportálása. ______ In 2004 and 2007 twelve New Member States (NMS) joined the European Union (EU), causing several changes in the field of agriculture. One of the major changes was the transformation of national agri-food trade. The aim of the paper is to analyse the effects of EU accession on NMS agri-food trade. Results suggest that the intensity of NMS agri-food trade has increased significantly after accession, though there was a serious deterioration in NMS agri-food trade balance in most cases. It has also become evident that NMS agri-food trade was highly concentrated by country and by product. Moreover, our analyses highlight one of the most important characteristics of NMS agri-food trade structure - the focus on agri-food raw materials in export together with agri-food processed products in import. Regarding comparative advantage, results suggest that relevant NMS agri-food products had a revealed comparative advantage before and after accession, though to a weakening extent. From the policy perspective, there is a clear need for structural changes in NMS agriculture and agri-food sector in order to tackle the negative tendencies of national agri-food trade. The most important long-term goal should be the production and export of higher value-added processed products based on domestic raw materials.

Perfil exportador e crescimento econômico: uma análise de painel para economias africanas

This study aims to evaluate the relationship between the export profile and the African GDP growth rate. Chapter 1 presents the literature on the subject and studies that analyze the specific case of Africa. There seems to be a consensus that exports contribute to economic growth. However, there is no consensus on the benefits that are incorporated from exported products. The divergence lies between the approach of the Natural Resources Curse, where concentration of exports in commodities does not contribute to economic growth. Another work line supports the idea there is no such relation. Chapter 2 presents, through descriptive analysis, macroeconomic and international trade data for African economies data. Based on data from 52 countries for the period 1990-2014, it can be observed that the African continent has improved in macroeconomic terms, with increased exports and economic growth rates, suggesting a positive relationship between the variables. Trade indicators show Africa's integration into the global economy, with European Union, USA, China and some emerging countries as main partners. In addition, the analysis showed that the export is concentrated in oil and agricultural commodities. Most African countries face a negative trade balance, depending of primary products exports with low added value and imports of manufactured goods. Finally, Chapter 3 presents an empirical research using panel data analysis. The results suggest, in general, evidences that exports are important for explaining the African economic growth rate of African economies can be stimulated by the expansion of the share of exports in GDP. The estimated coefficients are positive and statistically significant in both the fixed effect estimation, as the estimation by GMM System. The estimation of growth models for fixed or random effects indicates a direct and statistically significant relationship between export oil / minerals and the growth rate of African countries. Thus, the export profile turns out to be important to determine the growth rate. The results obtained from the estimates do not corroborate the literature arguments called Curse of Natural Resources for the period analyzed, since export natural resources, especially oil and minerals, were relevant to explain the performance of the growth rate of economies.

Les interconnexions électriques entre la France et ses voisins européens depuis 1970 : un vecteur méconnu de l'intégration européenne

Les ouvrages de transport d’électricité ont d’abord été pensés un par un, reliant un excédent de production à un besoin de consommation. Ils ont ainsi parfois très naturellement et dès l’origine traversé les frontières des États pour répondre à leur raison d’être. Les secteurs électriques se structurant fortement lorsque le virage électrique fut pris, les interconnexions entre pays furent conçues par les techniciens comme une mesure élémentaire de sûreté et d’équilibre de ce produit atypique qu’est l’électricité. En France plus particulièrement, lorsque la production électronucléaire se développa à partir des années 1970, ces interconnexions devinrent petit à petit sources de revenus pour l’entreprise nationale, et d’équilibre pour la balance commerciale nationale. L’intérêt grandissant porté au secteur électrique par les institutions européennes à la fin des années 1990 vient ébranler les acteurs économiques géographiques verticaux, et rebat les cartes des enjeux à adresser à une maille plus large que l’État nation. Dans ces transformations successives, les interconnexions aux frontières, et particulièrement aux frontières françaises, jouent ainsi un rôle tout à fait spécifique et de plus en plus structurant pour les économies ouvertes des pays européens. Les réseaux de transport électriques continuent ainsi une mutation entamée dans les années 1970 qui les a conduits de la condition de mal nécessaire à celle de vecteurs indispensables de transformation des économies européennes. L’objet de ce mémoire est d’illustrer la très grande capacité d’adaptation de ces organes industriels, économiques, sociétaux et politiques, dont on pourrait faussement penser qu’ils sont immobilisés par leur nature capitalistique, à travers les enjeux portés par les interconnexions aux frontières françaises. Les sources sont à la fois issues de données des opérateurs techniques, de la documentation – encore peu fréquente – sur ces sujets, ainsi que des statistiques officielles du ministère français. Cette capacité d’innovation et de développement de « couches de services » permet aujourd’hui aux grands réseaux de transport de traverser les époques et la variabilité des orientations de leurs environnements, durablement.

Les interconnexions électriques entre la France et ses voisins européens depuis 1970 : un vecteur méconnu de l'intégration européenne

Les ouvrages de transport d’électricité ont d’abord été pensés un par un, reliant un excédent de production à un besoin de consommation. Ils ont ainsi parfois très naturellement et dès l’origine traversé les frontières des États pour répondre à leur raison d’être. Les secteurs électriques se structurant fortement lorsque le virage électrique fut pris, les interconnexions entre pays furent conçues par les techniciens comme une mesure élémentaire de sûreté et d’équilibre de ce produit atypique qu’est l’électricité. En France plus particulièrement, lorsque la production électronucléaire se développa à partir des années 1970, ces interconnexions devinrent petit à petit sources de revenus pour l’entreprise nationale, et d’équilibre pour la balance commerciale nationale. L’intérêt grandissant porté au secteur électrique par les institutions européennes à la fin des années 1990 vient ébranler les acteurs économiques géographiques verticaux, et rebat les cartes des enjeux à adresser à une maille plus large que l’État nation. Dans ces transformations successives, les interconnexions aux frontières, et particulièrement aux frontières françaises, jouent ainsi un rôle tout à fait spécifique et de plus en plus structurant pour les économies ouvertes des pays européens. Les réseaux de transport électriques continuent ainsi une mutation entamée dans les années 1970 qui les a conduits de la condition de mal nécessaire à celle de vecteurs indispensables de transformation des économies européennes. L’objet de ce mémoire est d’illustrer la très grande capacité d’adaptation de ces organes industriels, économiques, sociétaux et politiques, dont on pourrait faussement penser qu’ils sont immobilisés par leur nature capitalistique, à travers les enjeux portés par les interconnexions aux frontières françaises. Les sources sont à la fois issues de données des opérateurs techniques, de la documentation – encore peu fréquente – sur ces sujets, ainsi que des statistiques officielles du ministère français. Cette capacité d’innovation et de développement de « couches de services » permet aujourd’hui aux grands réseaux de transport de traverser les époques et la variabilité des orientations de leurs environnements, durablement.

Empirical evidence of S-curves in the Colombian

The Marshall-Lerner condition, the J-curve and S-curve have emerged as theoretical and empirical foundations developed for the study of the interaction between exchange rates and international patterns of bilateral trade -- They have a significant bearing on thedevelopment of public policy, and are of equal interest to the academic and professional communities -- The most recently developed of these theories, the S-Curve, is named after the theorized short-run behavior to be found in the cross-correlation function of the real exchange rate and the trade balance -- Considering this theoretical context, the paper seeks empirical evidence of the existence of the S-Curve in the bilateral trade in commodity and non-commodity goods between Colombia and the United States and Venezuela, its main trading partners, for the yearly quarters between 1994:1 and 2009:4

Análisis del TLC entre Estados Unidos-Colombia en los estados de Idaho, Illinois e Indiana

La Escuela de Administración viene desarrollando proyectos de investigación encaminados a identificar las oportunidades de las empresas colombianas frente al Tratado de Libre Comercio con Estados Unidos. Por lo que este estudio busca entender por qué Estados Unidos es el principal socio de Colombia en términos de exportaciones. Dentro del presente estudio se presentan cifras de Colombia y Estados Unidos desde el año 2012 hasta el año 2015, los cuales permitieron identificar, analizar y estudiar la relación económica, el comportamiento en el tiempo y la evolución de ambos países. Con la entrada que tenía el TLC, el gobierno de Colombia y EE.UU. trataron de construir la confianza a mediano y largo plazo para los empresarios. Así que el trabajo se centró en analizar paso a paso las principales características que hicieron el TLC una de las relaciones más importantes que ha tenido hasta ahora el país, sin dejar de lado el contexto económico global y el contexto bilateral. Mediante WISER Trade la cual es una base de datos de flujos de comercio internacional, se recopilo la información necesaria para determinar cuáles son las principales oportunidades comerciales y se determinó que el sector agropecuario, y el sector industrial reflejan una alta competitividad con los Estados Americanos de Illinois, Indiana e Idaho, reflejando en las cifras de 2012 a 2015 un incremento en las exportaciones.

Diagnóstico del Tratado de Libre Comercio de Estados Unidos frente a las estrategias de internacionalización para las PYME de Colombia hacia Maryland y Massachusetts

La firma de Tratados de Libre Comercio se ha convertido en una influencia para el desarrollo de investigaciones que permitan determinar y evidenciar oportunidades que lleven al incremento de la balanza comercial lo cual entraña a su vez una serie de retos en cuanto a la competencia de las empresas locales en mercados foráneos para la exportación de productos y servicios más allá de las materias primas y la importación de ciertos bienes para la especialización y optimización en procesos operativos. El estudio de los antecedentes del TLC entre Colombia y Estados Unidos es fundamental para comenzar el diagnóstico del proyecto, de modo tal que se identifique el impacto que ha tenido a través del tiempo este acuerdo y la influencia que produce en los sectores económicos en Colombia el comportamiento de esta relación en la actualidad. Es necesario identificar las oportunidades de las PYME en Colombia, especialmente en las exportaciones hacia los estados de Maryland y Massachusetts; y determinar la demanda que se puede llegar a suplir en estos estados por parte de las PYMES de nuestro país, basados en las importaciones actuales que se están generando por parte de los mismos desde el mundo entero tomando como referencia Wiser y Trademap, bases de datos de comercio exterior.

Mercado internacional y balance de pagos = Commodity trade and the balance of payments

Incluye Bibliografía