Drug safety as a means of consumer protection: The approximation of laws in the EC medicinal products market and its limitations

The paper characterizes the present state of the approximation of laws in the EC medicinal products market and analyses the deficiencies of harmonization in different areas of drug safety law (marketing authorization, post-marketing control, coordination procedures). But even where the level of legalization and approximation of laws is high, different safety decisions are taken by national authorities. The approximation of laws does not automatically produce uniform safety decisions across the Community. Drug law can only set a framework for consumer protection; it cannot totally programme individual safety decisions. Therefore the paper proposes a European medicinal products authority which should be provided with the competence to decide on new medicinal products (pre-and post-marketing control). The consumer/patient interest in optimal drug safety should be integrated into the procedure of decision-making by a right of participation. Knowledgeable experts, authorized by consumer organizations, should be members of the advisory committee, a step that would help to institutionalize the needed critical discourse on medicinal product safety.

---

Arzneimittelsicherheit als ein Mittel des Verbraucherschutzes: die Rechtsangleichung auf dem europäischen Arzneitmittelmarkt und ihre Grenzen

Zusammenfassung Der Beitrag beschäftigt sich mit dem Thema unter rechtstheoretischer, rechtspraktischer und rechtspolitischer Perspektive.Rechtspolitisch geht es um die Umsetzung des Konzepts Verbraucherschutz/Patientenschutz durch Arzeimittelsicherheitsrecht. Dieses Konzept kann man als paternalistisch im Gegensatz zu den Ansätzen Informationsrechte oder Beteiligungsrechte bezeichnen, weil es durch eine Vorgabe von Sicherheitsstandards (Qualität, Wirksamkeit, Unbedenklichkeit) einen optimalen Schutz der Verbraucher/Patienten zu garantieren versucht.Rechtspraktisch wird die erreichte Rechtsangleichung durch die EG-Richtlinien und Empfehlungen dargestellt, aber es werden auch die Defizite der sicherheitsrechtlichen Harmonisierung herausgearbeitet. Solche Defizite bestehen kaum im Zulassungsrecht; wünschenswert wären dort zusätzlich Angleichungen der Verfahrensregeln für klinische Arzneimittelprüfungen und die rechtliche Regelung des Schutzes für Probanden und Patienten. Demgegenüber ist das Recht der Nachmarktkontrolle für Arzneimittel kaum angeglichen und sowohl im Bereich von Verfahren, Informationssammlung und Informationsbewertung harmonisierungsbedürftig. Insbesondere eine computerisierte Zusammenschaltung der unterschiedlichen Informationssystem über unerwünschte Arzneimittelwirkungen wäre vernünftig. Ebenfalls verbesserungsbedürftig sind die europäischen Koordinationsprozeduren (Mehrstaaten-, Konzertierungsverfahren) für Arzneimittelsicherheitsentscheidungen (Zulassungen, Überwachungsentscheidungen).Rechtstheoretisch werden die Grenzen der Rechtsangleichung als Folge der generalklauselartigen Weite der Sicherheitsstandards analysiert, die nur im Vollzug des Gesetzeszwecks durch Entscheidungsketten präzisiert und konkretisiert werden können. Eine unabweisbare Folge dieser Situation ist die Möglichkeit und Wahrscheinlichkeit unterschiedlicher nationaler Zulassungs- und Nachmarktkontrollentscheidungen.Der Beitrag analysiert die gegenwärtig diskutierten Lösungen (gegenseitige Anerkennung, erweiterte Koordinierungsprozeduren, europäische Arzneimittelbehörde) und bevorzugt eine einheitliche, wissenschaftlich beratene europäische Arzneimittelbehörde. Unter dem Gesichtspunkt einer Verbesserung des Verbraucherschutzes wird vorgeschlagen, Verbraucherorganisationen die Möglichkeit zu geben, ihre wissenschaftlichen Repräsentanten in das beratende Gremium zu senden, um auf diese Weise einen kritischen Diskurs über Arzneimittelsicherheit zu institutionalisieren.

---

---

Dieter Hart is Professor of Civil Law at the Faculty of Law, University of Bremen, POB 330440, D-2800 Bremen 33, FRG.     

The Unintended Consequences of Education Policies on South African Participation and Unemployment

In the late 1990s, the South African Department of Education implemented two policies that were meant to reduce the large number of over‐aged learners in the school system: schools were no longer allowed to accept students who were more than two years older than the correct grade age, and students could not be held back more than once in each of four schooling phases. Our analysis uses school administrative data and household survey data to show that these policies coincided with a decrease in school enrolment of at least 400,000 and possibly more than 900,000 learners. These policies appear to have pushed many students into the labour market at earlier ages than was observed for previous generations, which explains much of the sudden increase in labour force participation and unemployment during this period. However, since these individuals would probably have entered the labour market sooner if not for their poor employment prospects, we argue that the resulting increase in unemployment signifies a more accurate reflection of disguised unemployment that already existed in the mid‐1990s rather than a deterioration of labour market conditions.     

An analysis of the effect of the economic situation on modeling and forecasting the diffusion of wireless communications in Finland

In this paper, the diffusion of wireless communications in Finland is studied. The objectives are to find factors which have affected the diffusion process and to forecast the diffusion of wireless communications in Finland. The diffusion process is based on the epidemic diffusion theory. The data consists of annual wireless subscribers of networks based on Nordic Mobile Telephone (NMT) and Global System for Mobile Communications (GSM) standards in 1981-1998. The data is fitted into the logistic model by means of nonlinear least squares after writing two parameters of the logistic model as functions of certain variables. The results show that the economic situation has affected the relative growth rate, and that the wireless network coverage has affected the number of potential adopters. By extrapolating the logistic model, a forecast with a confidence interval of wireless communications subscriber rates in Finland is made. The forecast shows that the final penetration rate will be some 91.7% in 2009. The model predicts the actual figures of year 1999 very accurately. Finally, the time derivatives of the diffusion process are analyzed; they clarify the effect of economic situation on the diffusion.     

Neoclassical Growth, Manufacturing Agglomeration, and Terms of Trade

This study reverses the prediction of geography and growth models that trade integration may cause income divergence. Moreover, a new dynamic welfare gain of trade openness is identified. These results are obtained from embedding a new economic geography model into a neoclassical growth model. Starting from symmetric countries, a country that accumulates more capital than the other increases its home market size, improves its terms of trade, and lowers its relative consumption price index, because trade costs drive a wedge in between relative producer and consumption price indices. Both effects in turn tend to increase its marginal revenue product of capital relative to the other country (divergence forces), while factor substitution diminishes its marginal revenue product of capital (convergence force). Reducing trade costs decreases the wedge and weakens the divergence forces, while the convergence force is unaffected. Hence, divergence is more likely with higher rather than lower trade costs.     

Home-Market and Factor-Endowment Effects in a Gravity Approach

This paper shows how the home-market effect can be estimated in the generalized gravity equation of Bergstrand, taking into account traditional comparative advantage effects arising from differences in factor endowment. The empirical results suggest the presence of significant home-market effects for differentiated goods in many manufacturing industries which may be capital intensive or labour intensive. At the same time, our results suggest that home-market effects can only be detected for data disaggregated at the industry level and not for aggregated data. JEL no. F 12     

A PROPERTY TAXATION MECHANISM WITH SELF‐ASSESSMENT

This paper analyzes a variant of the classic idea for property taxation based on owner's self‐assessment. To induce reporting of market values tax authorities announce to purchase some of the properties randomly at declared values under certain conditions. These conditions are based on properties of the distribution of declared values. It is proven that a unique Nash equilibrium of this taxation game among tax payers exists in which all of them report market values and tax authorities do not purchase any property.     

US-Klimaschutzpolitik nach der Wahl

Zusammenfassung  Die USA wollen Ende 2009 gemeinsam mit über 190 L?ndern ein neues Klimaschutzabkommen aushandeln. Schon w?hrend des Wahlkampfes hatte Obama der Klimapolitik der Bush-Regierung eine Absage erteilt und selbst ehrgeizige Klimaschutzziele formuliert. Ob oder in welcher Form sich diese Ziele angesichts einer schw?chelnden US-Wirtschaft realisieren lassen, bleibt abzuwarten. Wie sind die Aussichten für ein neues Klimaschutzabkommen? Welche Position nehmen die USA gegenüber den Schwellen- und Entwicklungsl?ndern ein? Prof. Dr. Dieter Cansier, 68, lehrte Volkswirtschaftslehre, insbesondere Finanzwissenschaft, an der Universit?t Tübingen.     

Perfect competition in an oligopoly (including bilateral monopoly)

We show that if limit orders are required to vary smoothly, then strategic (Nash) equilibria of the double auction mechanism yield competitive (Walras) allocations. It is not necessary to have competitors on any side of any market: smooth trading is a substitute for price wars. In particular, Nash equilibria are Walrasian even in a bilateral monopoly.